AzTrials
AzTrials

Bladder CancerBLCCRNCT02660645

Blue Light Cystoscopy With Cysview® Registry

An observational study of Bladder Cancer, run by Photocure at 23 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Hexaminolevulinate hydrochloride (HCL) and Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Type of treatment
Medical device
How many people
4,400 participants
Where
23 sitesUnited States
Study dates
Apr 2014to Dec 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients indicated for transurethral resection of the bladder.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chad McKee, PhD contact

(919) 780-0417

chad.mckee@photocure.com

23 sites in 1 country

United States23 sites, 21 recruiting

  • Emory University School of Medicine

    Atlanta, Georgia, 30097

    Vikram Narayan, MD, (404) 778-4898

    Vikram Narayan, MD

    Recruiting

  • Johns Hopkins Medicine

    Baltimore, Maryland, 21224

    Morgan De Carli, Mdecarl2@jhmi.edu

    Max Kates, MD

    Recruiting

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Charles Peyton, MD, ccpeyton@uab.edu

    Charles Peyton, MD

    Recruiting

  • Charleston Area Medical Center

    Charleston, West Virginia, 25301

    Terminated

  • Northwestern University

    Chicago, Illinois, 60611

    Clay Arnett

    Joshua Meeks, MD

    Recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Kamal Pohar, MD, kamal.pohar@osumc.edu

    Kamal Pohar, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Rachel Link, CCRP, rachel.link@osumc.edu

    Kamal S Pohar, MD

    Recruiting

  • UT Southwestern

    Dallas, Texas, 75390

    Yair Lotan, MD, 214-645-8787

    Yair Lotan, MD

    Recruiting

  • Northshore University Health System

    Evanston, Illinois, 60201

    Adam Vanderloo

    Kristian Novakovic, MD

    Recruiting

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

    Ashley Jones, BS, CCRP, 713-791-1414 ext. 26694, Ashley.Jones2@bcm.edu

    Jennifer Taylor, MD, MPH

    Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

    Lehman G Jennifer, RN, CCRP, jgeck@iu.edu

    Hristos Z Kaimakliotis, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Jane Ledesma, 913-588-8721, jledesma2@kumc.edu

    John Taylor, MD, MS

    Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Ileana Aldana, 323-865-0702, ileana.aldana@med.usc.edu

    Sia Daneshmand, MD

    Recruiting

  • University of California Los Angeles

    Los Angeles, California, 90095

    Karim Chamie, MD, 310-794-7700

    Karim Chamie, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Maressa Twedt, 612-626-6661, twedt050@umn.edu

    Hamed Ahmadi, MD

    Recruiting

  • NYU Langone's Perlmutter Cancer Center

    New York, New York, 10016

    Gary Steinberg, MD, 646-825-6300

    Gary Steinberg, MD

    Recruiting

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

    Dorothy Trivedi, dtrivedi@stanford.edu

    Joseph Liao, MD

    Recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Mark Tyson, MD, MPH, tyson.mark@mayo.edu

    Mark Tyson, MD, MPH

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Sima Porten, MD, MPH, 415-885-3695, Sima.Porten@ucsf.edu

    Sima Porten, MD, MPH

    Recruiting

  • University of Washington Medicine

    Seattle, Washington, 98195

    John Gore, MD, (206) 598-4294

    John Gore, MD

    Recruiting

  • Stony Brook Urology

    Stony Brook, New York, 11794

    Suspended

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

    Armine Smith, MD, 202-660-5561

    Armine Smith, MD

    Recruiting

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

    Nicol Brandon, 704-414-2870 ext. 2809, Nicol.brandon@carolinaurologypartners.com

    T. Brian Willard, MD

    Recruiting

Other trials in United States

About this study

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.

Conditions
Bladder Cancer
Being tested
Hexaminolevulinate hydrochloride (HCL), Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
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)
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hexaminolevulinate hydrochloride (HCL)Drug

    Also called Cysview®, Hexvix®

    Instillation in bladder

  • Karl Storz D-Light C Photodynamic Diagnostic (PDD) systemDevice

    Cystoscopy procedure

Study groups in NCT02660645
Study groupRoleWhat they receive
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.
Receives: Drug: Hexaminolevulinate hydrochloride (HCL); Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of detection of bladder malignancies

    Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.

    Measured: 5 years

Secondary outcomes (5)

  1. False-positive detection rates

    Rates of false-positive lesion biopsies based on pathological findings

    Measured: 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

    Measured: 5 years

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

    Adverse events reporting

    Measured: 5 years

  4. Recurrence Rates

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

    Measured: 5 years

  5. Cystectomy Rate

    Proportion of patients who have a cystectomy performed

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2016 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
4,400 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02660645
Sponsor's protocol ID
BLCCR-001
Acronym
BLCCR
Status last verified
Dec 2025
First submitted
6 Jan 2016
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No

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, Kaul S, Fleishman 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, Gershman B. Performance of the EORTC and CUETO risk prediction models in contemporary patients undergoing transurethral resection of bladder tumor with blue light cystoscopy. Urol Oncol. 2026 Sep 15:S1078-1439(26)00695-2. doi: 10.1016/j.urolonc.2026.08.005. Online ahead of print.

    PubMed 42744708

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by Photocure at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chad McKee, PhD ((919) 780-0417, chad.mckee@photocure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of detection of bladder malignancies (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02660645, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in