Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-04-21 @ 9:56 AM
Study NCT ID:
NCT02857634
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confocal Microscopy Dual Band in the Management of Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Using PDD, urothelial lesions will be resected. The samples will be immediately investigated effect under confocal microscopy (Cellvizio dual band) in order to keep the fluoresceine effect. After confocal microscopy samples will be fixed in formalin and prepare for the pathologist that will confirm the diagnosis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the nucleo-cytoplasmic ratio of cells', 'timeFrame': 'at inclusion', 'description': 'In order to perform comparison between benign versus malignant cytology, significant differences between cytoplasmic areas and nuclear areas will be determine to stablish a value of nucleo-cytoplasmic ratio'}], 'secondaryOutcomes': [{'measure': 'Number of neoplastic lesions identified by Cellvizio compared to number of lesions identified by pathology', 'timeFrame': 'through the study completion, an average of 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary Bladder cancer', 'diagnosis', 'Cellvizio Dual Band'], 'conditions': ['Urinary Bladder Neoplasm']}, 'descriptionModule': {'briefSummary': 'Bladder cancer is one of the most common cancer worldwide and the second most frequent urological cancer. The photodynamic diagnosis technique (PDD) currently used (Hexvix®) has improved tumor detection but with a high false positive rate. Indeed, the main limitation of the PDD is its lack of specificity, ranging from 35 to 66%. The association of this technique with new technologies such as the Cellvizio Dual Band featuring simultaneous dual wavelength illumination and detection, could improve the identification of tumoral lesions. The objective of this study is to demonstrate the efficacy of Cellvizio dual band technique for the diagnosis of tumors bladders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients following a tumor resection of the bladder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having 18 years old or more\n* Patients with a bladder carcinoma and with indication of tumor resection under Hexvix procedure.\n* Patients giving consent to participate in the study\n\nExclusion Criteria:\n\n-No consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT02857634', 'acronym': 'HEXVISIO', 'briefTitle': 'Confocal Microscopy Dual Band in the Management of Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Study of the Contribution of Confocal Microscopy Dual Band in the Management of Bladder Cancer', 'orgStudyIdInfo': {'id': 'RC-P0035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bladder tumor resection', 'interventionNames': ['Device: Cellvizio dual band']}], 'interventions': [{'name': 'Cellvizio dual band', 'type': 'DEVICE', 'description': 'Using fluorescence cytoscopy, lesions in the bladder will be resected. The samples will be immediately observed in order to keep the fluorescein effect under confocal microscopy (Cellvizio dual band). After confocal microscopy samples will be fixed in formalin and prepare for the pathologist that will confirm the diagnosis. The Cellvizio system can be used to observe a resected sample ex vivo, offering a cellular-level view of internal tissue. This technique allows the visualization of the microstructure of the tissue in real-time which may improve targeted sampling, provide earlier disease detection and help patient management. The Cellvizio system includes miniaturized optics, optical fiber bundles, high-speed scanning and advanced image processing components.', 'armGroupLabels': ['Bladder tumor resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59462', 'city': 'Lomme', 'state': 'Nord', 'country': 'France', 'facility': "Groupement des Hôpitaux de l'Institut Catholique de Lille", 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}], 'overallOfficials': [{'name': 'Jean-Louis Bonnal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Urologie, Groupement des hôpitaux de l'Institut Catholique de Lille"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}