RecruitingPhase 3NCT06525571

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


Sponsor

Johns Hopkins University

Enrollment

200 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking outcomes for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are treated using blue light cystoscopy during their bladder tumor removal surgery (TURBT). Blue light technology makes cancer cells glow, helping surgeons more accurately detect and remove tumors. Researchers want to see if this approach improves long-term outcomes. **You may be eligible if...** - You are 18 or older - You are having TURBT surgery for a bladder tumor seen on imaging or scope - You start an intravesical (directly into the bladder) therapy within four weeks of surgery - Your upper urinary tract (kidneys and ureters) will be evaluated as part of standard care throughout the study **You may NOT be eligible if...** - Your tumor has less than 50% urothelial (bladder lining) cell type - You have or have had cancer in the upper urinary tract, or muscle-invasive bladder cancer - You have previously had pelvic radiation - You currently have an active urinary tract infection - You are unlikely to follow the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCysview

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.

DEVICEKarl 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

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NCT06525571


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