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

INTRODUCTION

• Org Study ID: IRB00442199
• Secondary ID: N/A
• NCT ID: NCT06525571
• Sponsor: Johns Hopkins University

DESCRIPTION

We are studying two ways to look inside the bladder during surgery to remove bladder cancer. One way uses regular white light (WLC), and the other uses blue light (BLC), which makes cancer areas glow and easier to see. This study is for patients with high-risk, non-muscle-invasive bladder cancer (HR NMIBC) to see which method helps remove cancer more completely and lowers the chances of it coming back.

With blue-light cystoscopy (BLC), doctors might see cancer more clearly, helping them remove it better during surgery. After surgery, we will check for any remaining cancer using standard tools like bladder exams and urine tests. We will also use a new urine test that looks for tiny traces of cancer to track if any cancer is left behind. Participants in the study will be randomly chosen to have surgery with either white light or blue light.

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.

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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.

• Overall Status
  Recruiting
• Start Date
  December 20, 2024
• Phase
  Phase 3
• Study Type
  Interventional