Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-03-01 @ 12:17 AM
Study NCT ID:
NCT03105869
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2017-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'test and retest in a single group of patient'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reproducibility of the results', 'timeFrame': '2 weeks', 'description': 'Comparison of the number and location of identified lesions and comparison of lesion uptake'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['repeatability', 'positron emission tomography (PET)', 'fluorocholine'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer', 'detailedDescription': 'A second PET/CT with fluorocholine is performed within 2 weeks after a first examination performed in patient referred for an initial prostate cancer or a biological suspicion of relapse.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* biological suspicion of relapse of prostate cancer or initial staging of prostate cancer\n* positive PET/CT with fluororocholine\n\nExclusion criteria :\n\n-none'}, 'identificationModule': {'nctId': 'NCT03105869', 'briefTitle': 'Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium', 'orgStudyIdInfo': {'id': 'RECHOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fluorocholine PET/CT', 'description': 'all patients will undergo a second PET/CT with fluorocholine', 'interventionNames': ['Diagnostic Test: fluorocholine PET/CT']}], 'interventions': [{'name': 'fluorocholine PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'standard diagnostic PET/CT procedure', 'armGroupLabels': ['fluorocholine PET/CT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catherine CHEZE LE REST', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Poitiers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}