Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-03-09 @ 7:03 AM
Study NCT ID:
NCT03808792
Status:
UNKNOWN
Last Update Posted:
2019-01-18
First Post:
2018-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Study in Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2018-10-28', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Method Friendly Questionnaire', 'timeFrame': '24 months', 'description': "Evaluation of patients' experience of the imaging modalities using Patient Method Friendly Questionnaire.\n\nThe aim of the questionnaire is to evaluate the overall experience through the different imaging methods and to evaluate relevant factors that may had a negative impact on the examination. The answers should be in a 4-point scale (1-very disappointing; 2-disappointing; 3- satisfied; 4-very satisfied) except the level of pain that should be in a 10-scale of pain (1 - no pain; 10 - maximum pain)"}, {'measure': 'Excluded patients', 'timeFrame': '24 months', 'description': 'Monitorization of excluded patients using an evaluation form filled by the principal investigator or study coordinator in each center. It has to be chosen one of the next options:\n\n1. Age \\<18 or \\> 80 years old\n2. Poor performance status ECOG \\>3\n3. Histologic report of biopsy of a non-gynecologic cancer\n4. Contraindications to upfront LPS or LPT (only tru-cut biopsy +/- NACT)\n5. Contraindications to CT\n6. Consent not given by the patient (denial or withdrawal of oral informed consent)\n7. Absence of insurance\n8. Time between ultrasound and surgery more than 4 weeks\n9. Current pregnancy\n10. Death\n11. Others, please specify:'}, {'measure': 'Record of choice of treatment', 'timeFrame': '24 months', 'description': 'Record of multidisciplinary team choice of primary surgery or neoadjuvant chemotherapy to clarify personal and external factors in decision making'}], 'primaryOutcomes': [{'measure': 'Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan.', 'timeFrame': '24 months', 'description': 'Optimal debulking is defined as residual disease \\<1cm'}], 'secondaryOutcomes': [{'measure': 'Assessment of the diagnostic performance in the detection of involvement of individual sites relevant for clinical management and in the detection of 24 individual sites described in the evaluation form.', 'timeFrame': '24 months', 'description': '1. Detection of involvement of individual sites relevant for clinical management:\n\n * Rectosigmoid\n * Colon (except ileocecum)\n * Ileocaecum\n * Lesser omentum\n * Small intestine\n * Liver\n * Diaphragm\n * Pleura\n2. Detection of 24 individual sites described in the evaluation form (17 peritoneal sites and 7 lymph nodes sites).\n\nThe aim is to clarify the diagnostic performance of the different imaging methods in the assessment of tumor extent in form of peritoneal carcinomatosis and metastatic lymph nodes. The investigators want to establish the overall accuracy of each imaging modality in all the metastatic sites. The major interest lies in the sites that determine the extent of surgery and optimal cytoreduction, in particular bowel resection, lesser omentum, superficial liver metastases, diaphragm or pleura.'}, {'measure': 'Prediction model of achievement of optimal cytoreduction.', 'timeFrame': '24 months', 'description': 'Prediction of optimal cytoreduction based on preoperative imaging. Optimal cytoreduction is defined as no residual tumor left at the end of surgery (R0).'}, {'measure': 'Markers influencing accuracy - FIGO stage', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods:\n\nFIGO stage - it will be analised if the accuracy of the imaging methods change between early stages (I-II) and late stages (III-IV) of the disease'}, {'measure': 'Markers influencing accuracy - Histological type', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods:\n\nHistological type - it will be analised if the accuracy of the imaging methods change between serous type and other histological types'}, {'measure': 'Markers influencing accuracy - Origin', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods: Origin - it will be analised if the accuracy of the imaging methods change between ovarian origin and tubal origin'}, {'measure': 'Markers influencing accuracy - Intraperitoneal fluid', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods:\n\nIntraperitoenal fluid - it will be analised if the accuracy of the imaging methods change between \\< or = 400 mL and \\> 400 mL'}, {'measure': 'Markers influencing accuracy - Age', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods:\n\nAge - it will be analised if the accuracy of the imaging methods change between women with \\< or = 65 and \\> 65 years old'}, {'measure': 'Markers influencing accuracy - CA 125', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods:\n\nCA 125 - it will be analised if the accuracy of the imaging methods change between \\< or = 300 U/mL and \\> 300 U/mL'}, {'measure': 'Markers influencing accuracy - Postmenopausal status', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods:\n\nPostmenopausal status - it will be analised if the accuracy of the imaging methods change between premnopausal and postmenopausal status'}, {'measure': 'Markers influencing accuracy - Body mass index', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods:\n\nBody mass índex - it will be analised if the accuracy of the imaging methods change between \\< or = 25 kg/m2 and \\> 25 kg/m2'}, {'measure': 'Markers influencing accuracy - Image quality', 'timeFrame': '24 months', 'description': 'Assessment of markers influencing diagnostic accuracy of individual methods:\n\nImage quality - it will be analised if the accuracy of the imaging methods change between good, moderate and poor image quality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovarian cancer', 'Ultrasound', 'CT', 'WB-DW/MRI', 'Imaging'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '40247746', 'type': 'DERIVED', 'citation': "Fischerova D, Pinto P, Pesta M, Blasko M, Moruzzi MC, Testa AC, Franchi D, Chiappa V, Alcazar JL, Wiesnerova M, Cibula D, Valentin L; collaborators. Ultrasound examiners' ability to describe ovarian cancer spread using preacquired ultrasound videoclips from a selected patient sample with high prevalence of cancer spread. Ultrasound Obstet Gynecol. 2025 May;65(5):641-652. doi: 10.1002/uog.29208. Epub 2025 Apr 18."}, {'pmid': '38531539', 'type': 'DERIVED', 'citation': 'Pinto P, Valentin L, Borcinova M, Wiesnerova M, Filip F, Burgetova A, Masek M, Lambert L, Chiappa V, Franchi D, Testa AC, Moro F, Avesani G, Panico C, Alessi S, Pricolo P, Vigorito R, Calareso G, Kocian R, Slama J, Fagotti A, Urbinati AMV, Signorelli M, Bertolina F, Cibula D, Fischerova D. Patient satisfaction with ultrasound, whole-body CT and whole-body diffusion-weighted MRI for pre-operative ovarian cancer staging: a multicenter prospective cross-sectional survey. Int J Gynecol Cancer. 2024 Jun 3;34(6):871-878. doi: 10.1136/ijgc-2023-005264.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is the assessment of tumour sites critical for the achievement of optimal cytoreduction in patients with advanced ovarian cancer using Ultrasound, CT and WB-DWI/MRI. The study uses an equivalence design with a hypothesis that cases with non-resectable disease identified by Index test (Ultrasound, CT and WB-DWI MRI) are equivalent to a portion of cases identified during surgery.', 'detailedDescription': 'Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer using subjective assessment by experienced sonographer (principal investigator) will be enrolled in the study and send to surgical planning. During surgical planning, the CT and MRI will be scheduled and the patient ́s consent will be requested if inclusion criteria are fulfilled. Please note, tumors with atypical morphology and/or tumor spread suspicious for secondary ovarian cancer will be first subjected to a tru-cut biopsy and will be included if histopathology confirms adnexal or peritoneal cancer.\n\nUltrasound will be always performed by the principal investigator in each center. Principal investigator is an ultrasound expert with level II or III EFSUMB accreditation (http://www.efsumb.org/). Operators performing ultrasound scan and radiologists performing CT or MRI will be well instructed and educated about standardized approach and criteria of inoperability. Sonographers and radiologists will be blinded to the results of other imaging modalities. If a patient already had CT or WB-DWI/MRI done by the referring hospital, the study radiologists will decide about the quality of imaging and necessity to repeat CT or WB-DWI/MRI.\n\nThe decision to treat by PDS (primary debulking surgery), or by NACT (neoadjuvant chemotherapy) with IDS (interval debulking surgery) will be based on departmental guidelines taking into account medical comorbidities and disease-related factors. If a patient is indicated for NACT a tru-cut biopsy or/and a diagnostic laparoscopy are performed. The clinicians will document why the primary debulking surgery was not considered. The surgery (laparoscopy, primary or interval debulking surgery) should always be performed within four weeks after the index test. Patients without surgical exploration will be excluded.\n\nSurgeons performing laparoscopy will describe site to site involvement and in case of inoperability will take a biopsy and document reasons for abandoning laparotomy. In operable cases surgeons performing laparotomy will describe site to site involvement and where applicable reasons for not achieving optimal cytoreduction defined as no residual tumor left in situ at the end of surgery (R0).\n\nIf the patient has only ultrasound and CT (and not WB-DWI/MRI) she can still be included in the study. Similarly if the patient undergoes interval debulking surgery she can be included in the study if the index tests will be performed less than 4 week before IDS.\n\nClinical data and four evaluation forms will be filled in (Ultrasound, CT, MRI, Surgery) immediately after the procedure using electronic database. The evaluation form from histopathology will be filled when available by principal investigator. The database cannot be saved unless all the information required are filled in and it will not be available to any other investigator. Data will be submitted for statistical analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer', 'genderDescription': 'Female patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer using subjective assessment by experienced sonographer.\n2. Surgery (PDS or IDS) within 4 weeks from the index test.\n3. 18 \\> Age \\< 80.\n4. ECOG (Eastern Cooperative Oncology Group) grade \\< 3.\n5. Patients after NACT can be included.\n\nExclusion Criteria:\n\n1. Lesions suspected as being borderline ovarian tumors (BOT) on ultrasound.\n2. Patients with supradiaphragmatic metastases\n3. Contraindications to CT\n4. Medical contraindications to surgery\n5. Refusal or withdrawal of written informed consent\n6. Time lapse between ultrasound and surgery more than 4 weeks\n7. Current pregnancy'}, 'identificationModule': {'nctId': 'NCT03808792', 'acronym': 'ISAAC', 'briefTitle': 'Imaging Study in Advanced Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'A Comparison Between Ultrasound, CT (CT) and Whole-body Diffusion-weighted MRI (WB-DWI/MRI) in the Assessment of Operability in Patients With Ovarian Cancer', 'orgStudyIdInfo': {'id': 'č.j. 29/18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ovarian cancer patients', 'description': 'Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer submitted to the index test (Ultrasound, CT and WB/DWI-MRI) with perspective of primary surgery', 'interventionNames': ['Diagnostic Test: Ultrasound, CT and WB-DWI/MRI']}], 'interventions': [{'name': 'Ultrasound, CT and WB-DWI/MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Preoperative assessment with Ultrasound, CT and WB-DWI/MRI', 'armGroupLabels': ['Ovarian cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15000', 'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Daniela Fischerová, MD, PhD', 'role': 'CONTACT', 'email': 'daniela.fischerova@seznam.cz', 'phone': '+420603285097'}], 'facility': 'Gynecologic Oncology Center in Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Patrícia Pinto, MD', 'role': 'CONTACT', 'email': 'aplpinto@gmail.com', 'phone': '+351912414130'}, {'name': 'Daniela Fischerová, MD, PhD', 'role': 'CONTACT', 'email': 'daniela.fischerova@seznam.cz', 'phone': '+420603285097'}], 'overallOfficials': [{'name': 'Daniela Fischerová, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital in Prague and 1st Medical Faculty of the Charles University, Prague, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ana Patrícia Pinto', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}