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

NCT ID: NCT06525571

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2028-01-04

Brief Summary

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.

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Blue light Cystoscopy

Patients with bladder tumors will undergo BLC TURBT

Group Type: EXPERIMENTAL

Cysview

Intervention Type: 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

Intervention Type: DEVICE

Cystoscopy procedure

White light Cystoscopy

Patients with bladder tumors will undergo WLC TURBT

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Cystoscopy procedure

Interventions

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.

Intervention Type: DRUG

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

Cystoscopy procedure

Intervention Type: DEVICE

Other Intervention Names

Hexyl aminolevulinate (HAL); Cystoscopy equipment to detect Cysview uptake in the bladder tumors

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Photocure ASA

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armine Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Sibley Memorial Hospital

Locations

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Domani Rodriguez

Role: CONTACT

drodri59@jh.edu

2026605561

Armine Smith, MD

Role: CONTACT

asmit165@jhmi.edu

2026605561

Facility Contacts

Rana Harb

Role: primary

rharb1@jhmi.edu

410-502-5500

Faizah Karim

Role: backup

fkarim4@jh.edu

Other Identifiers

IRB00442199

Identifier Type: -

Identifier Source: org_study_id