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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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Bladder Cancer

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Trial Information

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.


Inclusion Criteria:



- Patients scheduled for treatment of primary or recurrent non-muscle invasive bladder
cancer

- Patients greater than 18 years of age

- No tumors in the upper tract (kidneys or ureters)

- No previous pelvic radiation

Exclusion Criteria:

- Gross hematuria at the time of resection making visualization with NBI not possible

- Participation in other clinical studies with investigations drugs concurrently or
within 30 days.

- Pregnancy

- Conditions associated with a risk of poor compliance or unwilling to follow up

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

At 3 months and 1 year after treatment

Safety Issue:

No

Principal Investigator

Mitchell Humphreys, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

10-004660

NCT ID:

NCT01180478

Start Date:

August 2010

Completion Date:

August 2013

Related Keywords:

  • Bladder Cancer
  • Bladder Cancer
  • Urothelial carcinoma
  • Stage pTa or pT1
  • NMIBC Ta/T1
  • Narrow Band Imaging
  • White Light Cystoscopy
  • Transurethral resection
  • Superficial bladder tumor
  • Positive urine cytology
  • Urinary Bladder Neoplasms

Name

Location

Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404