Trials Today

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

Purpose

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.

Condition

Bladder Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Blue light Cystoscopy	Patients with bladder tumors will undergo BLC TURBT	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. Other names: Hexyl aminolevulinate (HAL) Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system Cystoscopy procedure Other names: Cystoscopy equipment to detect Cysview uptake in the bladder tumors
Active Comparator White light Cystoscopy	Patients with bladder tumors will undergo WLC TURBT	Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system Cystoscopy procedure Other names: Cystoscopy equipment to detect Cysview uptake in the bladder tumors

Recruiting Locations

Sibley Memorial Hospital
Washington, District of Columbia 20016

Johns Hopkins University School of Medicine
Baltimore, Maryland 21287

Contact:
Rana Harb
410-502-5500
rharb1@jhmi.edu

More Details

NCT ID: NCT06525571
Status: Recruiting
Sponsor: Johns Hopkins University

Study Contact

Riziki Covington
2026605561
rcoving5@jh.edu

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.