Comparing blue light and white light methods for bladder cancer surgery
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT06525571 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with high-risk non-muscle invasive bladder cancer who are undergoing TURBT.
Not a fit: Patients with variant histology, muscle-invasive bladder cancer, or active urinary tract infections may not benefit from this study.
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 performed: Previous studies have shown promising results with blue light cystoscopy, indicating potential advantages over traditional methods.
Eligibility criteria
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 this trial is running
Washington D.C., District of Columbia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.