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Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Sponsor: Johns Hopkins University
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-12-20
Completion Date
2028-01-04
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
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.
Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Cystoscopy procedure
Locations (2)
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States