Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06525571

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

Led by Johns Hopkins University · Updated on 2025-11-18

200

Participants Needed

2

Research Sites

158 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

P

Photocure ASA

Collaborating Sponsor

AI-Summary

What this Trial Is About

Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.

CONDITIONS

Official Title

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing TURBT for radiographic or cystoscopic positive tumor
  • 18+ years old
  • Upper tract evaluated using standard of care throughout duration of the study
  • Induction intravesical therapy initiated within four weeks of TURBT
Not Eligible

You will not qualify if you...

  • Variant histology consisting of less than 50% urothelial carcinoma
  • History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer
  • Prior history of pelvic radiation
  • Active urinary tract infection (UTI)
  • Patients who are noncompliant with the study protocol

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States, 20016

Actively Recruiting

2

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

D

Domani Rodriguez

CONTACT

A

Armine Smith, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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