Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT00785694
Status:
WITHDRAWN
Last Update Posted:
2015-04-24
First Post:
2008-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C419924', 'term': '5-aminolevulinic acid hexyl ester'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Rejected ethics approval in UK and Holland', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-23', 'studyFirstSubmitDate': '2008-11-04', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of bladder cancer recurrence', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is not of childbearing potential and signed informed consent.\n* Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.\n\nExclusion Criteria:\n\n* The subject was previously included in this study.\n* The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).\n* The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.\n* The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.\n* The subject has gross haematuria.\n* The subject has a history of porphyria.'}, 'identificationModule': {'nctId': 'NCT00785694', 'briefTitle': 'Recurrence of Bladder Cancer After Transurethral Resection With Hexvix', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Recurrence of Bladder Cancer After Transurethral Resection With Hexvix', 'orgStudyIdInfo': {'id': 'GE-196-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.', 'interventionNames': ['Drug: hexaminolevulinate']}, {'type': 'NO_INTERVENTION', 'label': 'A', 'description': 'Multiple instillations of mitomycin C after transurethral resection in white light alone.'}], 'interventions': [{'name': 'hexaminolevulinate', 'type': 'DRUG', 'otherNames': ['Hexvix'], 'description': 'Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78457', 'city': 'Vélizy-Villacoublay', 'state': 'Morane Saulnier', 'country': 'France', 'facility': 'GE Healthcare Medical Diagnostics', 'geoPoint': {'lat': 48.78198, 'lon': 2.19395}}], 'overallOfficials': [{'name': 'Jean-Paul Antonini', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GE Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}