Blue Light Cystoscopy With Cysview® Registry

Bladder Cancer Clinical Trial

— BLCCR  

Official title:

Blue Light Cystoscopy With Cysview® Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02660645
• Other study ID #: BLCCR-001
• Status: Recruiting
• Start date: April 2014
• Est. completion date: December 2028

Study information

• Verified date: March 2023
• Source: Photocure
• Contact: Chad McKee, PhD
• Phone: (919) 780-0417
• Email: chad.mckee[@]photocure.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

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 information / eligibility

• Status: Recruiting
• Enrollment: 4400
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult >18 years old
• Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy

Exclusion Criteria:

• Porphyria
• Gross hematuria
• Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Hexaminolevulinate hydrochloride (HCL)
Instillation in bladder

Device:
• Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Cystoscopy procedure

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Ohio State University	Columbus	Ohio
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California Los Angeles	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	NYU Langone's Perlmutter Cancer Center	New York	New York
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Mayo Clinic	Phoenix	Arizona
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington Medicine	Seattle	Washington
United States	Stony Brook Urology	Stony Brook	New York
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Lexington Medical Center	West Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Photocure	Catalyst Pharmaceutical Research

Country where clinical trial is conducted

United States, 

References & Publications (7)

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 cysto — View Citation

Alsyouf M, 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. Is a restaging TURBT ne — View Citation

Bazargani ST, Shah SH, Djaladat H, et al. Blue Light Cystoscopy For Diagnosis of Urothelial Bladder Cancer: Results: From A Prospective Registry. Poster presented at: The Annual meeting of Society of Urologic Oncology; December 2015; Washington, D.C.

Chappidi MR, Yang H, Meng MV, Bivalacqua TJ, Daneshmand S, Holzbeierlein JM, Kaimakliotis HZ, Konety B, Liao JC, Pohar K, Steinberg GD, Taylor JM, Tyson MD, Willard B, Lotan Y, Porten SP, Kates M. Utility of Blue Light Cystoscopy for Post-bacillus Calmett — View Citation

Daneshmand S, Bazargani ST, Bivalacqua TJ, Holzbeierlein JM, Willard B, Taylor JM, Liao JC, Pohar K, Tierney J, Konety B; Blue Light Cystoscopy with Cysview Registry Group. Blue light cystoscopy for the diagnosis of bladder cancer: Results from the US pro — View Citation

Daneshmand S, Patel S, Lotan Y, Pohar K, Trabulsi E, Woods M, Downs T, Huang W, Jones J, O'Donnell M, Bivalacqua T, DeCastro J, Steinberg G, Kamat A, Resnick M, Konety B, Schoenberg M, Jones JS; Flexible Blue Light Study Group Collaborators. Efficacy and — View Citation

Matulewicz RS, Ravvaz K, Weissert JA, Porten S, Steinberg GD; Blue Light Cystoscopy with Cysview Registry Group. Association of smoking status and recurrence of non-muscle invasive bladder cancer among patients managed with blue light cystoscopy. Urol Onc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of detection of bladder malignancies	Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.	5 years
Secondary	False-positive detection rates	Rates of false-positive lesion biopsies based on pathological findings	5 years
Secondary	Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone	Rate of additional margin detection with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone	5 years
Secondary	Proportion of patients with adverse events considered causally related to Cysview in repeat administration.	Adverse events reporting	5 years
Secondary	Recurrence Rates	Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview	5 years
Secondary	Cystectomy Rate	Proportion of patients who have a cystectomy performed	5 years