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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Maryland
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
Contact Information
Primary
Riziki Covington
rcoving5@jh.edu
2026605561
Backup
Armine Smith, MD
asmit165@jhmi.edu
2026605561
Time Frame
Start Date: 2024-12-20
Estimated Completion Date: 2028-01-04
Participants
Target number of participants: 200
Treatments
Experimental: Blue light Cystoscopy
Patients with bladder tumors will undergo BLC TURBT
Active_comparator: White light Cystoscopy
Patients with bladder tumors will undergo WLC TURBT
Related Therapeutic Areas
Sponsors
Collaborators: Photocure ASA
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov