Status:

RECRUITING

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

Lead Sponsor:

Johns Hopkins University

Collaborating Sponsors:

Photocure ASA

Conditions:

Bladder Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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...

Detailed Description

Objectives are as follows: Primary i) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

December 20 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 4 2028

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06525571

Start Date

December 20 2024

End Date

January 4 2028

Last Update

November 18 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Sibley Memorial Hospital

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

2

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287