Recruiting
Phase 3

WLC vs. BLC

Sponsor:

Johns Hopkins University

Code:

NCT06525571

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cysview

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

Study Details

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.

Conditions

Bladder Cancer

Study ID

NCT06525571

Start date

Dec 20, 2024

Status verified date

Nov, 2025

Completion date

Jan 4, 2028

Anticipated

Primary completion date

Jan 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Blue light Cystoscopy

Patients with bladder tumors will undergo BLC TURBT

active comparator: White light Cystoscopy

Patients with bladder tumors will undergo WLC TURBT

Interventions

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.

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

Cystoscopy procedure

Primary outcome measure

  • Residual disease burden [ Time Frame: Up to 24 months ]
  • Minimal residual disease burden [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Domani Rodriguez

2026605561drodri59@jh.edu

Armine Smith, MD

2026605561asmit165@jhmi.edu

Locations

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Rana Harb

410-502-5500rharb1@jhmi.edu

Faizah Karim

fkarim4@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • Blue light cystoscopy
  • Cysview

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-18.