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RECRUITING
NCT06525571
PHASE3

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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

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

Locations (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States