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RecruitingInterventionalPhase 3

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

NCT ID: NCT06525571Sponsor: Johns Hopkins UniversityLast updated: 2025-11-18

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.

Arms & 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

Outcome measures

Primary

  • Residual disease burden

    The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals.

    Time frame: Up to 24 months

  • Minimal residual disease burden

    Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals.

    Time frame: Up to 24 months

Secondary

  • Recurrence-free survival

    Time frame: 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016

Recruiting

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

Recruiting
Rana Harb · Contact
410-502-5500rharb1@jhmi.edu
Faizah Karim · Contact
fkarim4@jh.edu
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection | Cancerify