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

NCT06525571 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cysview

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.

DEVICE

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

Cystoscopy procedure

Sponsors & Collaborators

Principal Investigators

  • Armine Smith, MD · Sibley Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2027-01-04
Completion
2028-01-04
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06525571 on ClinicalTrials.gov