Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-21 @ 1:52 AM
Study NCT ID:
NCT03376360
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2017-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Medical Imaging Quantization in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2017-11-24', 'studyFirstSubmitQcDate': '2017-12-15', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between Gleason score and dynamic parameters on PET and MRI', 'timeFrame': 'when anatomopathological report is available, an average of 3 months after the PET/CT', 'description': 'study the potential correlation between dynamic parameters on PET and MRI'}], 'secondaryOutcomes': [{'measure': 'reconstructions on 18F-choline PET', 'timeFrame': 'when all 18F-choline PET are performed, an average of 6 months', 'description': 'determine the mean influx from each reconstruction which is the closest to the objective value'}, {'measure': 'best "fitting" on PET and MRI', 'timeFrame': 'when all MRI are performed, an average of 6 months', 'description': 'the Akaike Criteria Information was chose to choose the best fit'}, {'measure': 'comparison between data (PSA, TNM stage, EFS and OS)', 'timeFrame': '01/05/2017', 'description': 'comparison between data (PSA, TNM stage, EFS and OS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'Fcholine', 'positron emission tomography', 'MRI'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Prostate cancer is the most common cancer in men over 50 years old and the third leading cause of cancer death. Because of the variety of prostate cancers, different treatments exist.\n\nSeveral criteria guide this management in daily practice: PSA level; TNM stage (digital rectal examination, trans-rectal ultrasound and classical visual imaging) and pathological differentiation with the Gleason score, to which can be added other prognostic criteria: growth and doubling time of the serum PSA, number of positive biopsies and percentage of cancer lesions by biopsy.\n\nFunctional imaging by PET and MRI is increasingly used in daily clinical practice to characterize prostate cancer, either during initial discovery or during recurrence. In this context, it is the qualitative visual analysis that is mainly used. Quantitative image analysis could add new criteria to guide patient management.\n\nConsequently, the objective of this study were:\n\n* Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer\n* Comparison the quantitative parameters obtained by 18F-Choline PET / CT and both perfusion MRI and histological parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with prostate cancer histologically proven included in Brest University Hospital between 01/07/2012 and 01/10/2015 and underwent F-choline PET/CT and pelvic MRI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with prostate cancer histologically proven included in Brest University Hospital between 01/07/2012 and 01/10/2015 and underwent F-choline PET/CT and pelvic MRI Patient consent\n\nExclusion Criteria:\n\nNo lesion on dynamic acquisition on PET/CT and/or on pelvic MRI'}, 'identificationModule': {'nctId': 'NCT03376360', 'acronym': 'QUIP', 'briefTitle': 'Functional Medical Imaging Quantization in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer: Preliminary Results Concerning the Length of the Acquisition', 'orgStudyIdInfo': {'id': 'QUIP'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}