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RecruitingNCT02660645BLCCRUpdated Dec 18, 2025

Blue Light Cystoscopy With Cysview® Registry

An observational study in Bladder Cancer, sponsored by Photocure. Recruiting at 23 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Photocure · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
4,400
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Bladder Cancer

Keywords

  • Cysview
  • Hexaminolevulinate
  • Hexvix
  • NMIBC
  • BLCC
  • Blue Light Cystoscopy with Cysview
  • Cystoscopy
  • TURBT
  • TUR
  • Fluorescent cystoscopy
  • Non-muscle invasive bladder cancer (NMIBC)
  • Transurethral resection (TUR)
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 4,400 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Photocure is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients indicated for transurethral resection of the bladder.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Porphyria
  • Gross hematuria
  • Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
4,400 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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.

    Drug: Hexaminolevulinate hydrochloride (HCL) · Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

Interventions

  • DrugHexaminolevulinate hydrochloride (HCL)

    Instillation in bladder

    Also known as: Cysview®, Hexvix®

  • DeviceKarl Storz D-Light C Photodynamic Diagnostic (PDD) system

    Cystoscopy procedure

06

What researchers measure

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.

    Time frame: 5 years

Secondary outcomes

  1. False-positive detection rates

    Rates of false-positive lesion biopsies based on pathological findings

    Time frame: 5 years

  2. 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

    Time frame: 5 years

  3. Proportion of patients with adverse events considered causally related to Cysview in repeat administration.

    Adverse events reporting

    Time frame: 5 years

  4. Recurrence Rates

    Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview

    Time frame: 5 years

  5. Cystectomy Rate

    Proportion of patients who have a cystectomy performed

    Time frame: 5 years

07

Study locations

21 of 23 sites recruiting
  • The University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    • Charles Peyton, MD · Contact · ccpeyton@uab.edu
    • Charles Peyton, MD · Principal investigator
    Recruiting
  • Mayo Clinic
    Phoenix, Arizona 85054, United States
    • Mark Tyson, MD, MPH · Contact · tyson.mark@mayo.edu
    • Mark Tyson, MD, MPH · Principal investigator
    Recruiting
  • USC/Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
    • Ileana Aldana · Contact · ileana.aldana@med.usc.edu · 323-865-0702
    • Sia Daneshmand, MD · Principal investigator
    • Anne Schuckman, MD · Sub investigator
    • Mihir Desai, MD · Sub investigator
    • Hooman Djaladat, MD · Sub investigator
    • Gerhard Fuchs, MD · Sub investigator
    • Virinder Bhardwaj, MD · Sub investigator
    Recruiting
  • University of California Los Angeles
    Los Angeles, California 90095, United States
    • Karim Chamie, MD · Contact · 310-794-7700
    • Karim Chamie, MD · Principal investigator
    Recruiting
  • VA Palo Alto Health Care System
    Palo Alto, California 94304, United States
    • Dorothy Trivedi · Contact · dtrivedi@stanford.edu
    • Joseph Liao, MD · Principal investigator
    • James Crotty, MD · Sub investigator
    • John Leppert, MD · Sub investigator
    • John Lavelle, MD · Sub investigator
    Recruiting
  • University of California, San Francisco
    San Francisco, California 94143, United States
    • Sima Porten, MD, MPH · Contact · Sima.Porten@ucsf.edu · 415-885-3695
    • Sima Porten, MD, MPH · Principal investigator
    Recruiting
  • Sibley Memorial Hospital
    Washington D.C., District of Columbia 20016, United States
    • Armine Smith, MD · Contact · 202-660-5561
    • Armine Smith, MD · Principal investigator
    Recruiting
  • Emory University School of Medicine
    Atlanta, Georgia 30097, United States
    • Vikram Narayan, MD · Contact · (404) 778-4898
    • Vikram Narayan, MD · Principal investigator
    • Shreyas Joshi, MD · Sub investigator
    Recruiting
  • Northwestern University
    Chicago, Illinois 60611, United States
    • Clay Arnett · Contact
    • Joshua Meeks, MD · Principal investigator
    Recruiting
  • Northshore University Health System
    Evanston, Illinois 60201, United States
    • Adam Vanderloo · Contact
    • Kristian Novakovic, MD · Principal investigator
    Recruiting
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
    • Lehman G Jennifer, RN, CCRP · Contact · jgeck@iu.edu
    • Hristos Z Kaimakliotis, MD · Principal investigator
    Recruiting
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    • Jane Ledesma · Contact · jledesma2@kumc.edu · 913-588-8721
    • John Taylor, MD, MS · Principal investigator
    • Jeffrey Holzbeierlein, MD, FACS · Sub investigator
    Recruiting
  • Johns Hopkins Medicine
    Baltimore, Maryland 21224, United States
    • Morgan De Carli · Contact · Mdecarl2@jhmi.edu
    • Max Kates, MD · Principal investigator
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
    • Maressa Twedt · Contact · twedt050@umn.edu · 612-626-6661
    • Hamed Ahmadi, MD · Principal investigator
    • Subodh Regmi, MD · Sub investigator
    Recruiting
  • NYU Langone's Perlmutter Cancer Center
    New York, New York 10016, United States
    • Gary Steinberg, MD · Contact · 646-825-6300
    • Gary Steinberg, MD · Principal investigator
    Recruiting
  • Stony Brook Urology
    Stony Brook, New York 11794, United States
    Suspended
  • Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
    • Kamal Pohar, MD · Contact · kamal.pohar@osumc.edu
    • Kamal Pohar, MD · Principal investigator
    • Megan Merrill, DO · Sub investigator
    • Ahmad Shabsigh, MD · Sub investigator
    • David Sharp, MD · Sub investigator
    Recruiting
  • Ohio State University
    Columbus, Ohio 43210, United States
    Recruiting
  • Lexington Medical Center
    West Columbia, South Carolina 29169, United States
    • Nicol Brandon · Contact · Nicol.brandon@carolinaurologypartners.com · 704-414-2870
    • T. Brian Willard, MD · Principal investigator
    • David Lamb, MD · Sub investigator
    • Scott Sweazy, MD · Sub investigator
    • Keith Birghtbill, MD · Sub investigator
    • Michael Stotzer, MD · Sub investigator
    Recruiting
  • UT Southwestern
    Dallas, Texas 75390, United States
    • Yair Lotan, MD · Contact · 214-645-8787
    • Yair Lotan, MD · Principal investigator
    • Aditya Bagrodia, MD · Sub investigator
    Recruiting
  • Michael E. DeBakey VA Medical Center
    Houston, Texas 77030, United States
    • Ashley Jones, BS, CCRP · Contact · Ashley.Jones2@bcm.edu · 713-791-1414
    • Jennifer Taylor, MD, MPH · Principal investigator
    • Jeffrey Jones, MD · Sub investigator
    • Sidney Worsham, MD · Sub investigator
    Recruiting
  • University of Washington Medicine
    Seattle, Washington 98195, United States
    • John Gore, MD · Contact · (206) 598-4294
    • John Gore, MD · Principal investigator
    Recruiting
  • Charleston Area Medical Center
    Charleston, West Virginia 25301, United States
    Terminated
08

References and documents

Publications

  • 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. PubMed 36435710 ↗
  • 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. PubMed 38610946 ↗
  • 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. PubMed 39284074 ↗
  • 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. PubMed 34694916 ↗
  • 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. PubMed 29203268 ↗
  • 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 34637596 ↗
  • 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. PubMed 29859728 ↗
  • 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. PubMed 34053856 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02660645
Lead sponsor
Photocure
Collaborators
Catalyst Pharmaceutical Research
Responsible party
Sponsor
First posted
Jan 21, 2016
Start date
Apr 2014
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Dec 18, 2025

Study contacts

Chad McKee, PhD
Contact
chad.mckee@photocure.com
(919) 780-0417
Siamak Daneshmand, MD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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