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NCT Number: NCT06525571

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sibley Memorial Hospital, Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

Objectives are as follows:

Primary i) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among patients with a high-grade tumor at time of resection ii) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among all evaluable study participants.

Secondary i) Among all evaluable study participants: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.

ii) Among patients undergoing intravesical induction: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Hexyl aminolevulinate (HAL)

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

Device

Cystoscopy procedure

Other names: Cystoscopy equipment to detect Cysview uptake in the bladder tumors

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Recurrence-free survival

    Time frame: 24 months

    Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Armine Smith, MD

CONTACT

[email protected]

2026605561

Domani Rodriguez

CONTACT

[email protected]

2026605561

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Photocure ASA

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 29, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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