NCT00785694WithdrawnPhase 4
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- GE Healthcare
- Locations
- 1
- Primary Endpoint
- Rate of bladder cancer recurrence
Study Overview
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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
B
Experimental
One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.
Intervention: hexaminolevulinate (Drug)
Outcomes
Primary Outcomes
Rate of bladder cancer recurrence
Time Frame: 12 Months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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