Blue Light Cystoscopy With Cysview® Registry
- Conditions
- Bladder Cancer
- Interventions
- Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
- Registration Number
- NCT02660645
- Lead Sponsor
- Photocure
- Brief 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?
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4400
- Adult >18 years old
- Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy
- Porphyria
- Gross hematuria
- Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Blue Light Cystoscopy with Cysview® Hexaminolevulinate hydrochloride (HCL) Bladder cancer patients who have undergone Blue light cystoscopy with Hexaminolevulinate hydrochloride (Cysview®) 100mg in 50 milliliters (mL) reconstituted solution instilled intravesically into bladder prior to cystoscopy in operating room (OR). Retention time: 1-3 hours. The Karl Storz D-Light C Photodynamic Diagnostic (PDD) system is used for the cystoscopy procedure at the OR examination. Blue Light Cystoscopy with Cysview® Karl Storz D-Light C Photodynamic Diagnostic (PDD) system Bladder cancer patients who have undergone Blue light cystoscopy with Hexaminolevulinate hydrochloride (Cysview®) 100mg in 50 milliliters (mL) reconstituted solution instilled intravesically into bladder prior to cystoscopy in operating room (OR). Retention time: 1-3 hours. The Karl Storz D-Light C Photodynamic Diagnostic (PDD) system is used for the cystoscopy procedure at the OR examination.
- Primary Outcome Measures
Name Time Method Rate of detection of bladder malignancies 5 years Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.
- Secondary Outcome Measures
Name Time Method Cystectomy Rate 5 years Proportion of patients who have a cystectomy performed
Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone 5 years Rate of additional margin detection with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone
False-positive detection rates 5 years Rates of false-positive lesion biopsies based on pathological findings
Proportion of patients with adverse events considered causally related to Cysview in repeat administration. 5 years Adverse events reporting
Recurrence Rates 5 years Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview
Trial Locations
- Locations (23)
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Northshore University Health System
🇺🇸Evanston, Illinois, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
NYU Langone's Perlmutter Cancer Center
🇺🇸New York, New York, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Stony Brook Urology
🇺🇸Stony Brook, New York, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
University of Washington Medicine
🇺🇸Seattle, Washington, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Medicine
🇺🇸Baltimore, Maryland, United States
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States