Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Johns Hopkins University
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.
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 surveilla…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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
Interventions
- DrugCysview
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.
- DeviceKarl Storz D-Light C Photodynamic Diagnostic (PDD) system
Cystoscopy procedure
Locations (2)
- Sibley Memorial HospitalWashington D.C., District of Columbia
- Johns Hopkins University School of MedicineBaltimore, Maryland