Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Sponsor: Johns Hopkins University
ClinicalTrials ID:NCT06525571
This trial compares blue-light and white-light cystoscopy in TURBT for high-risk NMIBC. It evaluates MRD burden reduction and recurrence-free survival. Eligible participants are 18+ with positive tumors, undergoing standard care, and starting intravesical therapy within four weeks. Interventions include Cysview (HAL) and the Karl Storz D-Light C PDD system.
Patient Parameters
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Program Overview
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.
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.
Eligibility Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sibley Memorial Hospital | 20016 | Washington | District of Columbia |
| Johns Hopkins University School of Medicine | 21287 | Baltimore | Maryland |
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