Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-02-22 @ 10:56 PM
Study NCT ID:
NCT02792959
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'A.Cazeau@bordeaux.unicancer.fr', 'phone': '0556337860', 'title': 'Dr. Anne Laure Cazeau, Coordinating Investigator', 'organization': 'Institute Bergonie'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events are recorded from the first visit (J0 inclusion) until 4 weeks after the third PET/MRI examination. Beyond this period, only SAE likely to be related to the research or the medical device or to the procedure of implementation of the medical device are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anemia', 'notes': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Sinus tachycardia', 'notes': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Abdominal pain', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Ascites', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Bloating', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Constipation', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Diarrhea', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Nausea', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Fatigue', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Fever', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Allergic reaction', 'notes': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Bronchial infection', 'notes': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Enterocolitis infectious', 'notes': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Peritoneal infection', 'notes': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Urinary tract infection', 'notes': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Creatinine increased', 'notes': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Neutrophil count decreased', 'notes': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Platelet count decreased', 'notes': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Musculoskeletal and connective tissue disorder - Other, specify', 'notes': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Myalgia', 'notes': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Peripheral sensory neuropathy', 'notes': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Cystitis noninfective', 'notes': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Renal and urinary disorders - Other, specify', 'notes': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Reproductive system and breast disorders - Other, specify', 'notes': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Vaginal hemorrhage', 'notes': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Pleural effusion', 'notes': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Alopecia', 'notes': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Nail discoloration', 'notes': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Hypertension', 'notes': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Thromboembolic event', 'notes': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}], 'seriousEvents': [{'term': 'Anemia', 'notes': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Colonic obstruction', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Vomiting', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Sepsis', 'notes': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Supra-diaphragmatic', 'categories': [{'measurements': [{'value': '0.992', 'groupId': 'OG000', 'lowerLimit': '0.969', 'upperLimit': '0.998'}]}]}, {'title': 'Sus-mesocolic', 'categories': [{'measurements': [{'value': '0.997', 'groupId': 'OG000', 'lowerLimit': '0.987', 'upperLimit': '0.999'}]}]}, {'title': 'Sub-mesocolic', 'categories': [{'measurements': [{'value': '0.983', 'groupId': 'OG000', 'lowerLimit': '0.937', 'upperLimit': '0.996'}]}]}, {'title': 'Pelvis', 'categories': [{'measurements': [{'value': '0.997', 'groupId': 'OG000', 'lowerLimit': '0.988', 'upperLimit': '0.999'}]}]}, {'title': 'Viscera', 'categories': [{'measurements': [{'value': '0.951', 'groupId': 'OG000', 'lowerLimit': '0.826', 'upperLimit': '0.987'}]}]}, {'title': 'ADP', 'categories': [{'measurements': [{'value': '0.960', 'groupId': 'OG000', 'lowerLimit': '0.853', 'upperLimit': '0.990'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-therapeutic', 'description': 'Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.', 'unitOfMeasure': 'proportion of agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable population'}, {'type': 'PRIMARY', 'title': 'Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Supra-diaphragmatic', 'categories': [{'measurements': [{'value': '0.996', 'groupId': 'OG000', 'lowerLimit': '0.984', 'upperLimit': '0.999'}]}]}, {'title': 'Sus-mesocolic', 'categories': [{'measurements': [{'value': '0.999', 'groupId': 'OG000', 'lowerLimit': '0.993', 'upperLimit': '1.000'}]}]}, {'title': 'Sub-mesocolic', 'categories': [{'measurements': [{'value': '0.992', 'groupId': 'OG000', 'lowerLimit': '0.968', 'upperLimit': '0.998'}]}]}, {'title': 'Pelvis', 'categories': [{'measurements': [{'value': '0.998', 'groupId': 'OG000', 'lowerLimit': '0.994', 'upperLimit': '1.000'}]}]}, {'title': 'Viscera', 'categories': [{'measurements': [{'value': '0.975', 'groupId': 'OG000', 'lowerLimit': '0.905', 'upperLimit': '0.994'}]}]}, {'title': 'ADP', 'categories': [{'measurements': [{'value': '0.980', 'groupId': 'OG000', 'lowerLimit': '0.921', 'upperLimit': '0.995'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-therapeutic', 'description': 'Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography.\n\nThe functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.', 'unitOfMeasure': 'proportion of agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable population'}, {'type': 'PRIMARY', 'title': 'Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Supra-diaphragmatic', 'categories': [{'measurements': [{'value': '0.482', 'groupId': 'OG000', 'lowerLimit': '-0.079', 'upperLimit': '0.833'}]}]}, {'title': 'Sus-mesocolic', 'categories': [{'measurements': [{'value': '0.450', 'groupId': 'OG000', 'lowerLimit': '-0.165', 'upperLimit': '0.824'}]}]}, {'title': 'Sub-mesocolic', 'categories': [{'measurements': [{'value': '0.137', 'groupId': 'OG000', 'lowerLimit': '-0.606', 'upperLimit': '0.698'}]}]}, {'title': 'Pelvis', 'categories': [{'measurements': [{'value': '0.747', 'groupId': 'OG000', 'lowerLimit': '0.298', 'upperLimit': '0.929'}]}]}, {'title': 'Viscera', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000', 'lowerLimit': '-0.586', 'upperLimit': '0.616'}]}]}, {'title': 'ADP', 'categories': [{'measurements': [{'value': '0.881', 'groupId': 'OG000', 'lowerLimit': '0.614', 'upperLimit': '0.969'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-therapeutic', 'description': 'Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography.\n\nThe functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.', 'unitOfMeasure': 'proportion of agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable population'}, {'type': 'PRIMARY', 'title': 'Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - 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'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For patients with lesions (by location) after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions) and nine had sus-mesocolic lesions.'}, {'type': 'PRIMARY', 'title': 'Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Supra-diaphragmatic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.964', 'groupId': 'OG000', 'lowerLimit': '0.826', 'upperLimit': '0.993'}]}]}, {'title': 'Sus-mesocolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.791', 'groupId': 'OG000', 'lowerLimit': '0.073', 'upperLimit': '0.953'}]}]}, {'title': 'Sub-mesocolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.868', 'groupId': 'OG000', 'lowerLimit': '0.463', 'upperLimit': '0.967'}]}]}, {'title': 'Pelvis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.162', 'groupId': 'OG000', 'lowerLimit': '-1.753', 'upperLimit': '0.780'}]}]}, {'title': 'Viscera', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.814', 'groupId': 'OG000', 'lowerLimit': '0.311', 'upperLimit': '0.953'}]}]}, {'title': 'ADP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.891', 'groupId': 'OG000', 'lowerLimit': '0.485', 'upperLimit': '0.978'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.', 'unitOfMeasure': 'proportion of agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For patients with lesions (by location) after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions) and nine had sus-mesocolic lesions.'}, {'type': 'SECONDARY', 'title': 'Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVmax', 'categories': [{'measurements': [{'value': '-0.091', 'groupId': 'OG000', 'lowerLimit': '-0.679', 'upperLimit': '0.575'}]}]}, {'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter MTV', 'categories': [{'measurements': [{'value': '-0.030', 'groupId': 'OG000', 'lowerLimit': '-0.647', 'upperLimit': '0.612'}]}]}, {'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN', 'categories': [{'measurements': [{'value': '-0.212', 'groupId': 'OG000', 'lowerLimit': '-0.737', 'upperLimit': '0.491'}]}]}, {'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL', 'categories': [{'measurements': [{'value': '-0.212', 'groupId': 'OG000', 'lowerLimit': '-0.737', 'upperLimit': '0.491'}]}]}, {'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG', 'categories': [{'measurements': [{'value': '-0.164', 'groupId': 'OG000', 'lowerLimit': '-0.715', 'upperLimit': '0.526'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse.\n\nThe appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.\n\nThe disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.\n\nRelative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.', 'unitOfMeasure': "Spearman's correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable population'}, {'type': 'SECONDARY', 'title': 'Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVmax', 'categories': [{'measurements': [{'value': '0.811', 'groupId': 'OG000', 'lowerLimit': '0.082', 'upperLimit': '0.967'}]}]}, {'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter MTV', 'categories': [{'measurements': [{'value': '0.775', 'groupId': 'OG000', 'lowerLimit': '-0.012', 'upperLimit': '0.960'}]}]}, {'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN', 'categories': [{'measurements': [{'value': '0.811', 'groupId': 'OG000', 'lowerLimit': '0.082', 'upperLimit': '0.967'}]}]}, {'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL', 'categories': [{'measurements': [{'value': '0.811', 'groupId': 'OG000', 'lowerLimit': '0.082', 'upperLimit': '0.967'}]}]}, {'title': 'Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG', 'categories': [{'measurements': [{'value': '0.775', 'groupId': 'OG000', 'lowerLimit': '-0.012', 'upperLimit': '0.960'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse.\n\nThe appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.\n\nThe disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.\n\nRelative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.', 'unitOfMeasure': "Spearman's correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable population'}, {'type': 'SECONDARY', 'title': 'Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Relative variations between pre-therapeutic and after one cycle of chemotherapy', 'categories': [{'measurements': [{'value': '0.103', 'groupId': 'OG000', 'lowerLimit': '-0.567', 'upperLimit': '0.685'}]}]}, {'title': 'Relative variations between pre-therapeutic and after four cycles of chemotherapy', 'categories': [{'measurements': [{'value': '-0.571', 'groupId': 'OG000', 'lowerLimit': '-0.919', 'upperLimit': '0.361'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nThe appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.\n\nThe disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.', 'unitOfMeasure': "Spearman's correlation coefficient", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complete Surgery Resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'categories': [{'measurements': [{'value': '-25.4', 'spread': '33.1', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '-9.6', 'spread': '29.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.602', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.273', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-67.3', 'spread': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.3', 'spread': '31.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.067', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.361', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of SUVmax by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'categories': [{'measurements': [{'value': '-94.7', 'spread': '11.4', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '12.9', 'spread': '52.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4,390', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-38.5', 'spread': '47.6', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '5.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.091', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of MTV by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.8', 'spread': '28.8', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.6', 'spread': '22.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.794', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.068', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of SUVN by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-65.2', 'spread': '29.4', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.2', 'spread': '30.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.067', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.361', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of SUVN by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-63.5', 'spread': '52.4', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.2', 'spread': '12.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1,091', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of TLG by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-97.7', 'spread': '9.4', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '18.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.390', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of TLG by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.9', 'spread': '31.9', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.8', 'spread': '11.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.794', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.068', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of TLG by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-66.9', 'spread': '29.0', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.7', 'spread': '33.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.390', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of TLG by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '209.7', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '25.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.602', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.273', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of ADC by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': 'Partial response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '274.5', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.0', 'spread': '40.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.192', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.705', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'alpha=5%'}], 'paramType': 'MEDIAN', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).', 'unitOfMeasure': 'change in relative variance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative variations of SUVmax by response : 8 partial response and 2 stable disease'}, {'type': 'SECONDARY', 'title': 'Peritoneal Extent Assessed by Fagotti Score Using MRI Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'categories': [{'title': '4', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '8', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '10', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '12', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-therapeutic', 'description': 'The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread.\n\nThe Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases.\n\nThe sum of subscale values corresponds to Fagotti score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peritoneal Extent Assessed by Fagotti Score Using MRI Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '8', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '10', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery', 'description': 'TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread.\n\nThe Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases.\n\nThe sum of subscales corresponds to Fagotti score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '98.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 months', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival as Per RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'classes': [{'title': '9 months', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '98.5'}]}]}, {'title': '13 months', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000', 'lowerLimit': '38.1', 'upperLimit': '94.3'}]}]}, {'title': '14 months', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '88.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9, 13, 14 months', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The first steering committee (which met on 30th June, 2015) decided that one patient was not assessable for primary endpoint and had to be replaced. This patient deceased after the first line chemotherapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Functional Imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)\n\nFunctional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1\n\nFunctional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67.0', 'groupId': 'BG000', 'lowerLimit': '41.8', 'upperLimit': '77.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Proven epithelial carcinoma of gynaecological origin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Location of the tumour', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Ovaries', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Trunk', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Primitive peritoneal', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histological type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Serous', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Other type', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage of the tumour', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'III-c', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'IV', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The stage of tumour is graded from I-a to IV-c. The higher the stage number/letter is, the further the cancer has spread.', 'unitOfMeasure': 'Participants'}, {'title': 'Total Fagotti Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': '4', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '8', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '10', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '12', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not available', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy. The higher the stage number is, the further the cancer has spread.\n\nThe Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases.\n\nThe sum of all subscale values corresponds to Fagotti score.', 'unitOfMeasure': 'Participants'}, {'title': 'Performance status ECOG', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not available', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '0', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Performance status ECOG questionnaire is a tool for measuring the degree of autonomy of a person through his or her ability to carry out certain tasks of daily life.\n\nThe score ranges from 0 (able to carry out the same activity as before the illness without any restrictions) and stage 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) to stade 4 (unable to take care of himself, bedridden or in a chair all the time).', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'BG000', 'lowerLimit': '54.0', 'upperLimit': '78.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '164.0', 'groupId': 'BG000', 'lowerLimit': '150.0', 'upperLimit': '173.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of measurable initial lesions', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '5', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of non-target lesions', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': '2', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '5', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sum of the diameters', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '176.0', 'groupId': 'BG000', 'lowerLimit': '70.0', 'upperLimit': '310.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'diameters', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-25', 'studyFirstSubmitDate': '2016-04-26', 'resultsFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-25', 'studyFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pre-therapeutic', 'description': 'Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pre-therapeutic', 'description': 'Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography.\n\nThe functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pre-therapeutic', 'description': 'Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography.\n\nThe functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pre-therapeutic', 'description': 'Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography.\n\nThe functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pretherapeutic', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging.\n\nThe Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pretherapeutic', 'description': 'Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging.\n\nThe Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET).\n\nThe functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) .\n\nThe functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemoterapy, 3 weeks', 'description': 'Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).\n\nThe functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).\n\nThe functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) .\n\nThe functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET).\n\nThe functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemoterapy, 12 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV).\n\nThe functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).\n\nThe functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pre-therapeutic', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET).\n\nThe functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pre-therapeutic', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) .\n\nThe imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pre-therapeutic', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV).\n\nThe functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pre-therapeutic', 'description': 'Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography.\n\nThe functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pretherapeutic', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'Pretherapeutic', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) .\n\nThe Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemoterapy, 3 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET).\n\nThe functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After once cycle of chemoterapy, 3 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET).\n\nThe functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemoterapy, 3 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).\n\nThe functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After once cycle of chemotherapy, 3 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).\n\nThe functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemoterapy, 12 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET).\n\nThe functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemoterapy, 12 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET).\n\nThe functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycle of chemoterapy, 12 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET).\n\nThe functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET).\n\nThe functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}, {'measure': 'Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).\n\nThe Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.'}], 'secondaryOutcomes': [{'measure': 'Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse.\n\nThe appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.\n\nThe disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.\n\nRelative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.'}, {'measure': 'Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse.\n\nThe appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.\n\nThe disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.\n\nRelative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.'}, {'measure': 'Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125', 'timeFrame': 'After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nThe appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.\n\nThe disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.'}, {'measure': 'Complete Surgery Resection', 'timeFrame': 'Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1', 'timeFrame': 'After one cycle of chemotherapy, 3 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1', 'timeFrame': 'After four cycles of chemotherapy, 12 weeks', 'description': 'In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.\n\nRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).'}, {'measure': 'Peritoneal Extent Assessed by Fagotti Score Using MRI Data', 'timeFrame': 'Pre-therapeutic', 'description': 'The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread.\n\nThe Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases.\n\nThe sum of subscale values corresponds to Fagotti score.'}, {'measure': 'Peritoneal Extent Assessed by Fagotti Score Using MRI Data', 'timeFrame': 'Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery', 'description': 'TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread.\n\nThe Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases.\n\nThe sum of subscales corresponds to Fagotti score.'}, {'measure': 'Overall Survival', 'timeFrame': '10 months'}, {'measure': 'Progression-free Survival as Per RECIST v1.1', 'timeFrame': '9, 13, 14 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.e-cancer.fr/Professionnels-de-sante/Le-registre-des-essais-cliniques/Le-registre-des-essais-cliniques', 'label': "Registre des essais cliniques de l'Institut National du Cancer"}, {'url': 'https://www.bergonie.fr/essais_cliniques/', 'label': "Site internet du promoteur, l'Institut Bergonié"}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.', 'detailedDescription': 'This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated\n* Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy.\n* During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset.\n* A life expectancy of greater than three months\n* An eligible patient for Paclitaxel and Carboplatine based chemotherapy.\n* Membership of a social security scheme\n* Patient information and signed, dated written informed consent\n\nExclusion Criteria:\n\n* Pre-treated using chemotherapy, radiology, or surgery for an ovarian cancer.\n* Contraindication to MRI with the injection of contrast product, i.e, the first three months pregnancy, claustrophobia, major allergic antecedents, pacemaker, some surgery clips, some heart valves, cava filter, implanter pumps, cochlear implants, metallic extraneous malter.\n* Uncontrolled diabetes\n* Pregnancy and nursing\n* Other uncontrolled medical conditions as thyroid pathology, neuropsychiatric disease, infection, coronary insufficiency or grade 3 - 4 heart disease established by association "New York Heart"\n* Patient deprived of liberty and legally protect adult, or not in position to give consent.'}, 'identificationModule': {'nctId': 'NCT02792959', 'acronym': 'IMOVA', 'briefTitle': 'Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)', 'orgStudyIdInfo': {'id': 'IB 2013-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional imaging', 'description': 'A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)', 'interventionNames': ['Device: Functional Imaging previous the second course', 'Device: Functional Imaging previous the surgery']}], 'interventions': [{'name': 'Functional Imaging previous the second course', 'type': 'DEVICE', 'description': 'Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1', 'armGroupLabels': ['Functional imaging']}, {'name': 'Functional Imaging previous the surgery', 'type': 'DEVICE', 'description': 'Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval', 'armGroupLabels': ['Functional imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'state': 'Gironde', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Anne-Laure CAZEAU, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Bergonié'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'Ligue contre le cancer, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}