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Blue Light Resection for High-Risk Non-Muscle Invasive Bladder Cancer

This study is looking at how well a procedure called blue light cystoscopy (BLC) works for people with high-risk non-muscle invasive bladder cancer. BLC uses a drug called Cysview (hexyl aminolevulinate) and a special device (Karl Storz D-Light C Photodynamic Diagnostic system) to help doctors see bladder tumors more clearly during surgery. The goal is to see if BLC can remove more of the cancer compared to standard white light cystoscopy (WLC), which might lead to less cancer coming back. You could join if you are 18 or older and are having surgery for a bladder tumor. The study will measure how much cancer is left after surgery and if the cancer returns over 24 months. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 200 participants who will be randomly assigned to either the white light cystoscopy or blue light cystoscopy group.
What's involved
You will undergo a TURBT procedure and begin intravesical therapy within four weeks of the TURBT. Your upper tract will be evaluated using standard care throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Your residual disease burden and minimal residual disease burden will be measured for up to 24 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06525571

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

Recruiting
PHASE3Ages 18+Interventional
Johns Hopkins University
~200 participants
Updated 2025-11-18 on ClinicalTrials.gov
What's tested:CysviewKarl Storz D-Light C Photodynamic Diagnostic (PDD) system

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Residual disease burden
Measured over Up to 24 months
+1 more outcome measured

Conditions

Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT06525571

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins University School of Medicine

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • Sibley Memorial Hospital

    Washington D.C., District of Columbiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Armine Smith, MD · PRINCIPAL_INVESTIGATOR · Sibley Memorial Hospital

Who to contact

Domani Rodriguez
[email protected]
2026605561
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Residual disease burdenUp 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 burdenUp to 24 months

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