Blue Light Cystoscopy With Cysview® Registry (BLCCR)

December 10, 2025 updated by: Photocure
Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • The University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Charles Peyton, MD
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Mark Tyson, MD, MPH
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
        • Contact:
          • Karim Chamie, MD
          • Phone Number: 310-794-7700
        • Principal Investigator:
          • Karim Chamie, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Cancer Center
        • Sub-Investigator:
          • Anne Schuckman, MD
        • Sub-Investigator:
          • Mihir Desai, MD
        • Sub-Investigator:
          • Hooman Djaladat, MD
        • Sub-Investigator:
          • Gerhard Fuchs, MD
        • Sub-Investigator:
          • Virinder Bhardwaj, MD
        • Principal Investigator:
          • Sia Daneshmand, MD
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • VA Palo Alto Health Care System
        • Contact:
        • Principal Investigator:
          • Joseph Liao, MD
        • Sub-Investigator:
          • James Crotty, MD
        • Sub-Investigator:
          • John Leppert, MD
        • Sub-Investigator:
          • John Lavelle, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Sima Porten, MD, MPH
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
        • Principal Investigator:
          • Armine Smith, MD
        • Contact:
          • Armine Smith, MD
          • Phone Number: 202-660-5561
    • Georgia
      • Atlanta, Georgia, United States, 30097
        • Recruiting
        • Emory University School of Medicine
        • Principal Investigator:
          • Vikram Narayan, MD
        • Sub-Investigator:
          • Shreyas Joshi, MD
        • Contact:
          • Vikram Narayan, MD
          • Phone Number: (404) 778-4898
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
          • Clay Arnett
        • Principal Investigator:
          • Joshua Meeks, MD
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Northshore University Health System
        • Contact:
          • Adam Vanderloo
        • Principal Investigator:
          • Kristian Novakovic, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Contact:
        • Principal Investigator:
          • Hristos Z Kaimakliotis, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • John Taylor, MD, MS
        • Sub-Investigator:
          • Jeffrey Holzbeierlein, MD, FACS
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Medicine
        • Contact:
        • Principal Investigator:
          • Max Kates, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Hamed Ahmadi, MD
        • Sub-Investigator:
          • Subodh Regmi, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone's Perlmutter Cancer Center
        • Principal Investigator:
          • Gary Steinberg, MD
        • Contact:
          • Gary Steinberg, MD
          • Phone Number: 646-825-6300
      • Stony Brook, New York, United States, 11794
        • Suspended
        • Stony Brook Urology
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Kamal S Pohar, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Wexner Medical Center
        • Contact:
        • Sub-Investigator:
          • Megan Merrill, DO
        • Sub-Investigator:
          • Ahmad Shabsigh, MD
        • Sub-Investigator:
          • David Sharp, MD
        • Principal Investigator:
          • Kamal Pohar, MD
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Recruiting
        • Lexington Medical Center
        • Contact:
        • Principal Investigator:
          • T. Brian Willard, MD
        • Sub-Investigator:
          • David Lamb, MD
        • Sub-Investigator:
          • Scott Sweazy, MD
        • Sub-Investigator:
          • Keith Birghtbill, MD
        • Sub-Investigator:
          • Michael Stotzer, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern
        • Principal Investigator:
          • Yair Lotan, MD
        • Sub-Investigator:
          • Aditya Bagrodia, MD
        • Contact:
          • Yair Lotan, MD
          • Phone Number: 214-645-8787
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E. DeBakey VA Medical Center
        • Contact:
        • Principal Investigator:
          • Jennifer Taylor, MD, MPH
        • Sub-Investigator:
          • Jeffrey Jones, MD
        • Sub-Investigator:
          • Sidney Worsham, MD
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medicine
        • Principal Investigator:
          • John Gore, MD
        • Contact:
          • John Gore, MD
          • Phone Number: (206) 598-4294
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Terminated
        • Charleston Area Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients indicated for transurethral resection of the bladder.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Instillation in bladder
Other Names:
  • Cysview®
  • Hexvix®
Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Cystoscopy procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of detection of bladder malignancies
Time Frame: 5 years
Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
False-positive detection rates
Time Frame: 5 years
Rates of false-positive lesion biopsies based on pathological findings
5 years
Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone
Time Frame: 5 years
Rate of additional margin detection 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.
Time Frame: 5 years
Adverse events reporting
5 years
Recurrence Rates
Time Frame: 5 years
Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview
5 years
Cystectomy Rate
Time Frame: 5 years
Proportion of patients who have a cystectomy performed
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Photocure

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Catalyst Pharmaceutical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Siamak Daneshmand, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BLCCR-001

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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