Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
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:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Recurrence of Bladder Cancer After Transurethral Resection With Hexvix|
- Rate of bladder cancer recurrence [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.
Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.
Other Name: Hexvix
No Intervention: A
Multiple instillations of mitomycin C after transurethral resection in white light alone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785694
|GE Healthcare Medical Diagnostics|
|Velizy Cedex, Morane Saulnier, France, 78457|
|Study Director:||Jean-Paul Antonini||GE Healthcare|