Status:
WITHDRAWN
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
Lead Sponsor:
GE Healthcare
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 mitomyc...
Eligibility Criteria
Inclusion
- The subject is not of childbearing potential and signed informed consent.
- 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.
Exclusion
- The subject was previously included in this study.
- The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).
- 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.
- The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.
- The subject has gross haematuria.
- The subject has a history of porphyria.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00785694
Start Date
December 1 2008
End Date
August 1 2011
Last Update
April 24 2015
Active Locations (1)
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1
GE Healthcare Medical Diagnostics
Vélizy-Villacoublay, Morane Saulnier, France, 78457