drugset / Trial / NCT06525571

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

NCT06525571

Phase 3 Recruiting 200 enrolled Johns Hopkins University Photocure ASA · collab
RandomizedParallel-groupOpen-labelOther

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 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.

Timeline

Start
2024-12-20
Primary completion
2027-01-04
Completion
2028-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject hexaminolevulinate Small molecule