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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | January 4, 2027 |
| Study ends | January 4, 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT06525571 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
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.