Blue Light Cystoscopy With Cysview® Registry
Summary
Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
Detailed description
Data will be captured on specific patient types undergoing Blue Light Cystoscopy with Cysview for known or suspected non-muscle invasive bladder cancer. Specific clinical questions will be asked. 1. What is the incremental detection rate with Blue Light Cystoscopy with Cysview over conventional white light cystoscopy in each of the seven (7) patient populations? Does this translate into lower recurrence/progression rate? 2. How do the six (6) tumor variables used in the European Association of Urology (EAU) risk tables (primary/secondary, recurrence rate, size, multifocality, grade, and history of carcinoma in situ (CIS))6 affect this incremental rate? 3. How does an abnormal cytology or positive or negative fluorescent in situ hybridization (FISH) affect the likelihood that Blue Light Cystoscopy with Cysview will detect more cancers than white light? 4. What are the performance characteristics of Blue Light Cystoscopy with Cysview within eight (8) weeks of Bacillus Calmette-Guérin (BCG) with respect to improved tumor detection and false positive rate compared to conventional white light cystoscopy? 5. What is the incremental Blue Light Cystoscopy with Cysview detection rate over random bladder biopsies alone in patients being evaluated for routine three month restaging (group 4) or occult disease (group 5)? 6. What are the performance characteristics of Blue Light Cystoscopy with Cysview after repeated Blue Light Cystoscopy with Cysview evaluations with respect to improved tumor detection, false positive rate and safety compared to conventional white light? 7. Does an abnormal urinalysis help identify patients with inflammation more likely to have false positive Blue Light Cystoscopy with Cysview results? 8. What is the practical learning curve for becoming "proficient" with Blue Light Cystoscopy with Cysview? 9. What is the overall false positive rate with Blue Light Cystoscopy with Cysview? 10. Can Blue Light Cystoscopy with Cysview make the resection more complete? If yes, is this due to improved margins and/or additional tumors seen under blue light? 11. What are the performance characteristics of BLC™ with Cysview® on patients with variant histology? 12. How does BLC™ with Cysview® impact detection of tumors in surveillance and patient management decisions? 13. How does BLC™ with Cysview® impact management of small tumors during office biopsy/fulguration? 14. How can BLC impact patient selection for bladder cancer sparing drugs? 15. Does the combination of BLC with urine biomarkers guide appropriate therapy and or change management? 16. Does BL have an impact on long term outcomes such as recurrence or progression? 17. Can AI models be optimized and validated to accurately predict patient response to intravesical therapy (such as BCG or intravesical chemotherapy) in non-muscle invasive bladder cancer? 18. How concordant are the predictions of AI algorithms with treatment decisions documented in real-world clinical registries? 19. How do AI-predicted responses correlate with patient outcomes, including recurrence and progression, within predefined clinical subgroups such as 'BCG-naïve' or 'no prior intravesical treatment'? 20. What is the potential impact of implementing AI-based predictive models on changes in management (e.g., treatment selection, patient management, and overall care outcomes)? The Blue Light Cystoscopy with Cysview Registry is a web-based program supported by Global Vision Technologies. Data will be captured longitudinally over five (5) years on patients from each enrolled site. Each center will enter their respective site's patient data electronically.
Arms & interventions
- DrugHexaminolevulinate hydrochloride (HCL)
Instillation in bladder
- DeviceKarl Storz D-Light C Photodynamic Diagnostic (PDD) system
Cystoscopy procedure
Outcome measures
Primary
Rate of detection of bladder malignancies
Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.
Time frame: 5 years
Secondary
False-positive detection rates
Time frame: 5 years
Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone
Time frame: 5 years
Proportion of patients with adverse events considered causally related to Cysview in repeat administration.
Time frame: 5 years
Recurrence Rates
Time frame: 5 years
Cystectomy Rate
Time frame: 5 years
Eligibility criteria
Study locations (23)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Mayo Clinic
Phoenix, Arizona, 85054
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of California Los Angeles
Los Angeles, California, 90095
VA Palo Alto Health Care System
Palo Alto, California, 94304
University of California, San Francisco
San Francisco, California, 94143
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Emory University School of Medicine
Atlanta, Georgia, 30097
Northwestern University
Chicago, Illinois, 60611
Northshore University Health System
Evanston, Illinois, 60201
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Johns Hopkins Medicine
Baltimore, Maryland, 21224
University of Minnesota
Minneapolis, Minnesota, 55455
NYU Langone's Perlmutter Cancer Center
New York, New York, 10016
Stony Brook Urology
Stony Brook, New York, 11794
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Ohio State University
Columbus, Ohio, 43210
Lexington Medical Center
West Columbia, South Carolina, 29169
UT Southwestern
Dallas, Texas, 75390
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
University of Washington Medicine
Seattle, Washington, 98195
Charleston Area Medical Center
Charleston, West Virginia, 25301
References
- Ghoreifi A, et al. Upstaging and risk migration with blue light cystoscopy for non-muscle-invasive bladder cancer: Results from a prospective multi-center registry. J Clin Oncol. 2025 Feb;43(5 Suppl):686. https://doi.org/10.1200/JCO.2025.43.5_suppl.686
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- Ahmadi H, Ladi-Seyedian SS, Konety B, Pohar K, Holzbeierlein JM, Kates M, Willard B, Taylor JM, Liao JC, Kaimakliotis HZ, Porten SP, Steinberg GD, Tyson MD, Lotan Y, Daneshmand S; Blue Light Cystoscopy with Cysview Registry Group. Role of blue-light cystoscopy in detecting invasive bladder tumours: data from a multi-institutional registry. BJU Int. 2022 Jul;130(1):62-67. doi: 10.1111/bju.15614. Epub 2021 Oct 26.(PubMed)
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