A Multi-center, International Study to Compare Use of Narrow Band Imaging (NBI) Versus White Light(WL) During Transurethral Resection of Bladder Tumors (TURB) to Asses Recurrence of Bladder Cancer in Terms of Safety and Efficacy
Currently bladder tumors are diagnosed visually with standard cystoscopy that uses white
light, or light that is generated encompassing the entire visual spectrum. Some tumors such
as carcinoma in situ may not be visible using white light and require patients to undergo
random bladder biopsies in order to find the cancer. Recently the development of
photodynamic agents have been shown to enhance these procedures to accomplish better
resection and identify over-looked tumors. However, these methods often require the
instillation of dyes into the bladder as well as specialized cystoscopes. Narrow band
imaging (NBI) is now available which uses a special filter to limit the light to only
certain wavelengths which allows the identification of areas of increased vascularity or
abnormalities without the need for dyes. NBI has been investigated in gastro-intestinal
disease and found to be beneficial. Early reports in urology suggest that this technology
may reduce the number of tumors that are missed which could impact the recurrence rate of
bladder tumors, but this is not known at this time.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recurrence rate at 1 year following Narrow Band Imaging and TURB (Arm A) versus White Light Trans Urethral Resection of Bladder cancer (TURB) (Arm B) in patients with non muscle invasive (pTa/T1) bladder cancer.
At 3 months and 1 year after treatment
No
Mitchell Humphreys, MD
Principal Investigator
Mayo Clinic
United States: Institutional Review Board
10-004660
NCT01180478
August 2010
August 2013
Name | Location |
---|---|
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |