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

Phase 3

Recruiting

• Conditions: Bladder Cancer
• Interventions: Drug: Cysview; Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

• Registration Number: NCT06525571
• Lead Sponsor: Johns Hopkins University

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-29
• Study Start: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2027-01-04
• Study Completion: 2028-01-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blue light Cystoscopy	Cysview	Patients with bladder tumors will undergo BLC TURBT
White light Cystoscopy	Karl Storz D-Light C Photodynamic Diagnostic (PDD) system	Patients with bladder tumors will undergo WLC TURBT
Blue light Cystoscopy	Karl Storz D-Light C Photodynamic Diagnostic (PDD) system	Patients with bladder tumors will undergo BLC TURBT

Primary Outcome Measures

Name	Time	Method
Residual disease burden	Up to 24 months	The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals.
Minimal residual disease burden	Up to 24 months	Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals.

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival	24 months	Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause.

Trial Locations

Locations (2)

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States