Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Sponsor
GE Healthcare
Study ID
NCT00785694
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • hexaminolevulinate — DRUG
    Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.

Study Details

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).

Key Dates

Start date
Dec 31, 2008
Status verified
Apr 2015
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: B
    One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.
  • No Intervention: A
    Multiple instillations of mitomycin C after transurethral resection in white light alone.

Primary Outcome Measure

Rate of bladder cancer recurrence [ Time Frame: 12 Months ]

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