Bladder Cancer
Conditions
Keywords
Blue light cystoscopy, Cysview
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.
Interventions
DRUGCysview
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.
Cystoscopy procedure
Sponsors
Photocure ASA
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual disease burden | Up to 24 months | The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals. |
| Minimal residual disease burden | Up to 24 months | Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 24 months | Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause. |
Countries
United States
Contacts
Primary ContactDomani Rodriguez
Backup ContactArmine Smith, MD
Outcome results
None listed