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Trial Title:
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
NCT ID:
NCT06525571
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Aminolevulinic Acid
Conditions: Keywords:
Blue light cystoscopy
Cysview
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cysview
Description:
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.
Arm group label:
Blue light Cystoscopy
Other name:
Hexyl aminolevulinate (HAL)
Intervention type:
Device
Intervention name:
Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Description:
Cystoscopy procedure
Arm group label:
Blue light Cystoscopy
Arm group label:
White light Cystoscopy
Other name:
Cystoscopy equipment to detect Cysview uptake in the bladder tumors
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 4, 2025
Completion date:
January 4, 2028
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Collaborator:
Agency:
Photocure ASA
Agency class:
Other
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06525571
