Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blue Light Cystoscopy With Cysview® Registry (BLCCR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02660645
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
KARL STORZ Endoscopy-America, Inc.
Information provided by (Responsible Party):
Photocure

Tracking Information
First Submitted Date January 6, 2016
First Posted Date January 21, 2016
Last Update Posted Date September 4, 2019
Study Start Date April 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2018)
Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone. [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: January 18, 2016)
Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone. [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT02660645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 12, 2018)
  • False-positive detection rates [ Time Frame: 5 years ]
  • Complete resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone [ Time Frame: 5 years ]
  • Proportion of patients with adverse events considered causally related to Cysview in repeat administration. [ Time Frame: 5 years ]
Original Secondary Outcome Measures
 (submitted: January 18, 2016)
  • False-positive detection rates [ Time Frame: 2 years ]
  • Complete resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone [ Time Frame: 2 years ]
  • Proportion of patients with adverse events considered causally related to Cysview in repeat administration. [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blue Light Cystoscopy With Cysview® Registry
Official Title Blue Light Cystoscopy With Cysview® Registry
Brief Summary Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
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 [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients indicated for transurethral resection of the bladder.
Condition Bladder Cancer
Intervention
  • Drug: Hexaminolevulinate hydrochloride (HCL)
    Instillation in bladder
    Other Names:
    • Cysview®
    • Hexvix®
  • Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
    Cystoscopy procedure
Study Groups/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.
Interventions:
  • Drug: Hexaminolevulinate hydrochloride (HCL)
  • Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 18, 2016)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anthony Fernandez (609) 759 6500 af@photocure.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02660645
Other Study ID Numbers BLCCR-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Photocure
Study Sponsor Photocure
Collaborators KARL STORZ Endoscopy-America, Inc.
Investigators
Principal Investigator: Siamak Daneshmand, MD University of Southern California
PRS Account Photocure
Verification Date September 2019