Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-27 @ 3:13 AM
Study NCT ID:
NCT02971995
Status:
COMPLETED
Last Update Posted:
2016-11-23
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081364', 'term': 'Multiparametric Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of image guided prostate biopsy in the zones detected by the TEP scan', 'timeFrame': 'at inclusion'}], 'secondaryOutcomes': [{'measure': 'Number of image guided prostate biopsy in the zones detected by the mpMRI', 'timeFrame': 'at inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasm', 'Positron-Emission Tomography', 'Fluorocholine']}, 'descriptionModule': {'briefSummary': 'Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection).\n\nThe goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspicion of prostate cancer\n* Patients who performed prostate mpMRI and F-Choline 18 PET scan\n* Patient capable of receiving clear informations\n* Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)\n* Patient covered by a healthcare insurance\n\nExclusion Criteria:\n\n* Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan'}, 'identificationModule': {'nctId': 'NCT02971995', 'acronym': 'PROSTEPIRM', 'briefTitle': 'Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies in Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'OBS025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prostate cancer/TEP scan', 'interventionNames': ['Device: PET Scan ou TEP-TDM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prostate cancer/mpMRI', 'interventionNames': ['Device: mpMRI']}], 'interventions': [{'name': 'PET Scan ou TEP-TDM', 'type': 'DEVICE', 'description': 'Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy', 'armGroupLabels': ['Prostate cancer/TEP scan']}, {'name': 'mpMRI', 'type': 'DEVICE', 'description': 'Performance of the mpMRI in order to determine the place where to take the biopsy', 'armGroupLabels': ['Prostate cancer/mpMRI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean Louis Bonnal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GHICL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}