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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system; Drug: Cysview

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Armine Smith, MD; Phone Number: 2026605561; Email: asmit165@jhmi.edu
• Study Contact Backup: Name: Domani Rodriguez; Phone Number: 2026605561; Email: drodri59@jh.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Recruiting
      • Sibley Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Rana Harb; Phone Number: 410-502-5500; Email: rharb1@jhmi.edu
      • Contact: Faizah Karim; Email: fkarim4@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue light Cystoscopy; Patients with bladder tumors will undergo BLC TURBT	Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system; Cystoscopy procedure; Other Names: Cystoscopy equipment to detect Cysview uptake in the bladder tumors; 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.; Other Names: Hexyl aminolevulinate (HAL)
Active Comparator: White light Cystoscopy; Patients with bladder tumors will undergo WLC TURBT	Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system; Cystoscopy procedure; Other Names: Cystoscopy equipment to detect Cysview uptake in the bladder tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual disease burden	The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals.	Up to 24 months
Minimal residual disease burden	Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival	Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause.	24 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Photocure ASA
• Investigators: Principal Investigator: Armine Smith, MD, Sibley Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2028

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cysview; Blue light cystoscopy
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Therapeutics; Drug Therapy; Drug Delivery Systems; 5-aminolevulinic acid hexyl ester
• Other Study ID Numbers: IRB00442199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes