NCT06525571 · Johns Hopkins University
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
Residual disease burden
Time frame: Up to 24 months
The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals.
Minimal residual disease burden
Time frame: Up to 24 months
Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Washington D.C., District of Columbia
- Baltimore, Maryland
Collaborators
Photocure ASA
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 18, 2025 · Source of record for eligibility and locations