Blue Light Cystoscopy With Cysview® Registry (BLCCR)

March 27, 2023 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

Recruiting

Conditions

Intervention / Treatment

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?

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

Observational

Enrollment (Anticipated)

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 Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • The University of Alabama at Birmingham
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
        • Contact:
          • Karim Chamie, MD
          • Phone Number: 310-794-7700
      • 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
      • 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, 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
        • Contact:
          • Vikram Narayan, MD
          • Phone Number: 404-778-4898
        • Principal Investigator:
          • Vikram Narayan, MD
        • Sub-Investigator:
          • Shreyas Joshi, 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:
    • 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
    • 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
        • Contact:
          • John Gore, MD
          • Phone Number: 206-598-4294
        • Principal Investigator:
          • John Gore, MD
    • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

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

Photocure

Collaborators

Catalyst Pharmaceutical Research

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

April 1, 2014

Primary Completion (Anticipated)

December 1, 2028

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 18, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLCCR-001

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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