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

Johns Hopkins University

Status and phase: Enrolling; Phase 3

Conditions: Bladder Cancer

Treatments: Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system; Drug: Cysview

Study type: Interventional

Funder types: Other

Identifiers

NCT06525571

IRB00442199

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Blue light Cystoscopy

Experimental group

Description:

Patients with bladder tumors will undergo BLC TURBT

Treatment:

Drug: Cysview

Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

White light Cystoscopy

Active Comparator group

Description:

Patients with bladder tumors will undergo WLC TURBT

Treatment:

Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system