NCT06525571

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
20mo left

Started Dec 2024

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Dec 2024Jan 2028

First Submitted

Initial submission to the registry

July 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2028

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

July 24, 2024

Last Update Submit

November 17, 2025

Conditions

Bladder Cancer

Keywords

Blue light cystoscopyCysview

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Recurrence-free survival

    24 months

Study Arms (2)

Blue light Cystoscopy

EXPERIMENTAL

Patients with bladder tumors will undergo BLC TURBT

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

White light Cystoscopy

ACTIVE COMPARATOR

Patients with bladder tumors will undergo WLC TURBT

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

Interventions

CysviewDRUG

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.

Also known as: Hexyl aminolevulinate (HAL)
Blue light Cystoscopy
Karl Storz D-Light C Photodynamic Diagnostic (PDD) systemDEVICE

Cystoscopy procedure

Also known as: Cystoscopy equipment to detect Cysview uptake in the bladder tumors
Blue light CystoscopyWhite light Cystoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing TURBT for radiographic or cystoscopic positive tumor
  • + years old
  • Upper tract evaluated using standard of care throughout duration of the study
  • Induction intravesical therapy initiated within four weeks of TURBT

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

5-aminolevulinic acid hexyl esterDrug Delivery Systems

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Armine Smith, MD

    Sibley Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Domani Rodriguez

CONTACT

2026605561drodri59@jh.edu

Armine Smith, MD

CONTACT

2026605561asmit165@jhmi.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2024

First Posted

July 29, 2024

Study Start

December 20, 2024

Primary Completion (Estimated)

January 4, 2027

Study Completion (Estimated)

January 4, 2028

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)