Blue Light Cystoscopy With Cysview® Registry
BLCCR
1 other identifier
observational
4,400
1 country
23
Brief Summary
Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2014
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 6, 2016
CompletedFirst Posted
Study publicly available on registry
January 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
December 18, 2025
December 1, 2025
14.7 years
January 6, 2016
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
False-positive detection rates
5 years
Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone
5 years
Proportion of patients with adverse events considered causally related to Cysview in repeat administration.
5 years
Recurrence Rates
5 years
Cystectomy Rate
5 years
Study Arms (1)
Blue Light Cystoscopy with Cysview®
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.
Interventions
Instillation in bladder
Cystoscopy procedure
Eligibility Criteria
Patients indicated for transurethral resection of the bladder.
You may qualify if:
- Adult \>18 years old
- Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy
You may not qualify if:
- Porphyria
- Gross hematuria
- Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Photocurelead
- Catalyst Pharmaceutical Researchcollaborator
Study Sites (23)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Emory University School of Medicine
Atlanta, Georgia, 30097, United States
Northwestern University
Chicago, Illinois, 60611, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins Medicine
Baltimore, Maryland, 21224, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
NYU Langone's Perlmutter Cancer Center
New York, New York, 10016, United States
Stony Brook Urology
Stony Brook, New York, 11794, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Ohio State University
Columbus, Ohio, 43210, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
UT Southwestern
Dallas, Texas, 75390, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
University of Washington Medicine
Seattle, Washington, 98195, United States
Charleston Area Medical Center
Charleston, West Virginia, 25301, United States
Related Publications (12)
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
BACKGROUNDAlsyouf 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 necessary in high-risk NMIBC if the initial TURBT was performed with blue light? Urol Oncol. 2023 Feb;41(2):109.e9-109.e14. doi: 10.1016/j.urolonc.2022.10.026. Epub 2022 Nov 24.
PMID: 36435710RESULTLadi-Seyedian SS, Ghoreifi A, Konety B, Pohar K, Holzbeierlein JM, Taylor J, 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. Racial Differences in the Detection Rate of Bladder Cancer Using Blue Light Cystoscopy: Insights from a Multicenter Registry. Cancers (Basel). 2024 Mar 24;16(7):1268. doi: 10.3390/cancers16071268.
PMID: 38610946RESULTPerez-Londono A, et al. Performance of the EORTC and CUETO risk prediction models in contemporary patients undergoing transurethral resection of bladder tumor with blue light cystoscopy. J Urol. 2025;213(5 Suppl):e105.
RESULTPerez-Londono A, et al. Predicting recurrence and progression in contemporary patients with NMIBC undergoing blue light cystoscopy-aided transurethral resection of bladder tumor. J Urol. 2025;213(5 Suppl):e101.
RESULTGhoreifi A, Daneshmand S. Technical Considerations to Minimize False-Positive Findings in Blue Light Cystoscopy for Nonmuscle-Invasive Bladder Cancer. J Urol. 2025 Jan;213(1):5-7. doi: 10.1097/JU.0000000000004250. Epub 2024 Sep 16. No abstract available.
PMID: 39284074RESULTBazargani 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.
RESULTChappidi 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 Calmette-Guerin Bladder Cancer Recurrence Detection: Implications for Clinical Trial Recruitment and Study Comparisons. J Urol. 2022 Mar;207(3):534-540. doi: 10.1097/JU.0000000000002308. Epub 2021 Oct 25.
PMID: 34694916RESULTDaneshmand 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 Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. J Urol. 2018 May;199(5):1158-1165. doi: 10.1016/j.juro.2017.11.096. Epub 2017 Dec 2.
PMID: 29203268RESULTAhmadi 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.
PMID: 34637596RESULTDaneshmand 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 prospective multicenter registry. Urol Oncol. 2018 Aug;36(8):361.e1-361.e6. doi: 10.1016/j.urolonc.2018.04.013. Epub 2018 May 30.
PMID: 29859728RESULTMatulewicz 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 Oncol. 2021 Dec;39(12):833.e19-833.e26. doi: 10.1016/j.urolonc.2021.04.028. Epub 2021 May 28.
PMID: 34053856RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siamak Daneshmand, MD
University of Southern California
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2016
First Posted
January 21, 2016
Study Start
April 1, 2014
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
December 18, 2025
Record last verified: 2025-12