Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4400 participants
OBSERVATIONAL
2014-04-30
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Hexaminolevulinate hydrochloride (HCL)
Instillation in bladder
Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Cystoscopy procedure
Interventions
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Hexaminolevulinate hydrochloride (HCL)
Instillation in bladder
Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Cystoscopy procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy
Exclusion Criteria
* Gross hematuria
* Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives
18 Years
ALL
No
Sponsors
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Catalyst Pharmaceutical Research
INDUSTRY
Photocure
INDUSTRY
Responsible Party
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Principal Investigators
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Siamak Daneshmand, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Northshore University Health System
Evanston, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
NYU Langone's Perlmutter Cancer Center
New York, New York, United States
Stony Brook Urology
Stony Brook, New York, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Lexington Medical Center
West Columbia, South Carolina, United States
UT Southwestern
Dallas, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
University of Washington Medicine
Seattle, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Charles Peyton, MD
Role: primary
Mark Tyson, MD, MPH
Role: primary
Ileana Aldana
Role: primary
Karim Chamie, MD
Role: primary
Dorothy Trivedi
Role: primary
Sima Porten, MD, MPH
Role: primary
Armine Smith, MD
Role: primary
Vikram Narayan, MD
Role: primary
Clay Arnett
Role: primary
Adam Vanderloo
Role: primary
Lehman G Jennifer, RN, CCRP
Role: primary
Jane Ledesma
Role: primary
Morgan De Carli
Role: primary
Maressa Twedt
Role: primary
Gary Steinberg, MD
Role: primary
Kamal Pohar, MD
Role: primary
Rachel Link, CCRP
Role: primary
Nicol Brandon
Role: primary
Yair Lotan, MD
Role: primary
Ashley Jones, BS, CCRP
Role: primary
John Gore, MD
Role: primary
References
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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
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 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.
Ladi-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.
Perez-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.
Perez-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.
Ghoreifi 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.
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 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.
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 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.
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.
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 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.
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 Oncol. 2021 Dec;39(12):833.e19-833.e26. doi: 10.1016/j.urolonc.2021.04.028. Epub 2021 May 28.
Other Identifiers
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BLCCR-001
Identifier Type: -
Identifier Source: org_study_id