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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Johns Hopkins University
Study ID
NCT06525571
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cysview — DRUG
    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 — DEVICE
    Cystoscopy procedure

Study Details

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.

Key Dates

Start date
Dec 20, 2024
Status verified
Nov 2025
Primary completion
Jan 4, 2027
Completion
Jan 4, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
Johns Hopkins University School of MedicineBaltimoreMaryland21287
Rana Harb
[email protected]
410-502-5500
Faizah Karim
[email protected]

Find similar trials in Washington D.C., DC

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Sibley Memorial Hospital· Washington D.C., DCJohns Hopkins University School of Medicine· Baltimore, MD

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