NCT06525571

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 patients with a high-grade tumor at time of resection ii) 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 all evaluable study participants. Secondary i) Among all evaluable study participants: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm. ii) Among patients undergoing intravesical induction: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Cysview	Blue light cystoscopy uses hexyl aminolevulinate (HAL, branded in the United States as Cysview), a prodrug which accumulates in the bladder tumors and improves the tumor's visualization.
DEVICE	Karl Storz D-Light C Photodynamic Diagnostic (PDD) system	Cystoscopy procedure

Timeline

• Start date: 2024-12-20
• Primary completion: 2027-01-04
• Completion: 2028-01-04
• First posted: 2024-07-29
• Last updated: 2025-11-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study