Blue Light Cystoscopy With Cysview® Registry (BLCCR)

  • STATUS
    Recruiting
  • End date
    Dec 3, 2025
  • participants needed
    4400
  • sponsor
    Photocure
Updated on 26 January 2022
cancer
bladder cancer
invasive bladder cancer
cystoscopy
bladder tumor

Summary

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

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-Gurin (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.

Details
Condition Bladder Cancer
Treatment Hexaminolevulinate hydrochloride (HCL), Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Clinical Study IdentifierNCT02660645
SponsorPhotocure
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Step 1 Connect with a study center
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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