RECRUITINGPhase 3INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients undergoing TURBT for radiographic or cystoscopic positive tumor - 18+ years old - Upper tract evaluated using standard of care throughout duration of the study - Induction intravesical therapy initiated within four weeks of TURBT Who Should NOT Join This Trial: - Variant histology consisting of less than 50% urothelial carcinoma - History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer - Prior history of pelvic radiation - Active urinary tract infection (UTI) - Patients who are noncompliant with the study protocol Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients undergoing TURBT for radiographic or cystoscopic positive tumor * 18+ years old * Upper tract evaluated using standard of care throughout duration of the study * Induction intravesical therapy initiated within four weeks of TURBT Exclusion Criteria: * Variant histology consisting of less than 50% urothelial carcinoma * History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer * Prior history of pelvic radiation * Active urinary tract infection (UTI) * Patients who are noncompliant with the study protocol

Treatments Being Tested

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