Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-12 @ 3:52 AM
Study NCT ID:
NCT03157856
Status:
TERMINATED
Last Update Posted:
2019-01-15
First Post:
2017-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Results obtained on the first 8 patients shown an expected glandular membrane specific labeling associated with non-specific labeling of fibro-muscular tissue.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).', 'timeFrame': '14 months', 'description': 'Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard).', 'timeFrame': '14 months', 'description': 'Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluorescence imaging technique', 'Biopsies from resected prostate', 'Medical device'], 'conditions': ['Cancer Prostate']}, 'descriptionModule': {'briefSummary': 'In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:\n\n1. / the FEMTO-ST institute medical device,\n2. / the confocal microscope that will be used to measure fluorescence spectra of biological samples.', 'detailedDescription': 'For this protocol, 12 patients will be included.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with indication for radical prostatectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male patient over 18 years old\n* patient with indication for radical prostatectomy\n* patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.\n\n * patient affiliated to French social security system or equivalent\n * patient who have signed a non-opposition form\n\nExclusion Criteria:\n\n* patient with contraindication to radical prostatectomy\n* patient with remedial prostatectomy\n* patient with normal preoperative MRI or with absence of tumoral area\n* patient with history of hormonal therapy\n* person deprived of freedom by judicial or administrative decision\n* person under legal protection\n* person hospitalized for psychiatric care.'}, 'identificationModule': {'nctId': 'NCT03157856', 'acronym': 'Bio-Prost', 'briefTitle': 'Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection', 'orgStudyIdInfo': {'id': '38RC17.019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental: fluorescence assessment', 'description': 'Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue.', 'interventionNames': ['Other: Fluorescence assessment']}], 'interventions': [{'name': 'Fluorescence assessment', 'type': 'OTHER', 'description': 'All subjects of the study are going to have a radical prostatectomy. The FEMTO-ST medical device is used on 3 fresh biopsies (2 healthy and 1 malignant) which will be prelevated from the resected prostate in order to determine the prostatic or non-prostatic nature of tissue.', 'armGroupLabels': ['Experimental: fluorescence assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble Alpes University Hospital - Urology department', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble Alpes University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean Luc Descotes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble Alpes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'TIMC-IMAG', 'class': 'OTHER'}, {'name': 'Clinical Investigation Centre for Innovative Technology Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}