Cysview
DrugBlue 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.
Other names: Hexyl aminolevulinate (HAL)
NCT Number: NCT06525571
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Sibley Memorial Hospital, Washington D.C., District of Columbia, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Hexyl aminolevulinate (HAL)
Cystoscopy procedure
Other names: Cystoscopy equipment to detect Cysview uptake in the bladder tumors
Time frame: 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.
Time frame: Up to 24 months
Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals.
Time frame: 24 months
Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause.
Contact information is provided by the study sponsor or research team.
Armine Smith, MD
CONTACT
Domani Rodriguez
CONTACT
Johns Hopkins University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06963346
Bladder Cancer, Female Urogenital Diseases
Tampa, Florida, United States
View Trial DetailsNCT07660055
Bladder Cancer, Breast Cancer
Darlinghurst, New South Wales, Australia
View Trial DetailsNCT07419295
Bladder Cancer, Female Urogenital Diseases
Traverse City, Michigan, United States
View Trial DetailsNCT06465069
Adnexal Diseases, Advanced Solid Tumor
Duarte, California, United States
View Trial Details