Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 and up

Comparing blue light and white light methods for bladder cancer surgery

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

Run by Johns Hopkins University · NCT06525571 · Data updated 2026-11-12

This study is testing whether using blue light during bladder cancer surgery can help patients with high-risk non-muscle invasive bladder cancer have better outcomes than using regular white light.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorJohns Hopkins University
Academic / other
Drugs / interventionsradiation
Locations2 sites (Washington D.C., District of Columbia and 1 other locations)
StatusRecruiting
StartedDecember 20, 2024
Main results expectedJanuary 4, 2027
Study endsJanuary 4, 2028
Registry record updatedNovember 3, 2026
Trial IDNCT06525571 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with high-risk non-muscle invasive bladder cancer who are undergoing TURBT.

Probably not a fit

Patients with variant histology, muscle-invasive bladder cancer, or active urinary tract infections may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of blue light cystoscopy (BLC) versus white light cystoscopy (WLC) in patients with high-risk non-muscle invasive bladder cancer (NMIBC) undergoing transurethral resection of bladder tumor (TURBT). Patients will be randomly assigned to receive either BLC or WLC, and the study will evaluate outcomes such as the reduction in minimal residual disease (MRD) burden and recurrence-free survival at 12 and 24 months. The trial utilizes advanced imaging techniques and urine next-generation sequencing to assess treatment efficacy and disease recurrence.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with bladder cancer.

How similar studies have gone: Previous studies have shown promising results with blue light cystoscopy, indicating potential advantages over traditional methods.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Sibley Memorial Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Armine Smith, MD — Sibley Memorial Hospital
  • Study coordinator: Domani Rodriguez
  • Email: drodri59@jh.edu
  • Phone: 2026605561

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.