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BRIEF TITLE: Blue Light Cystoscopy With Cysview® Registry

Blue Light Cystoscopy With Cysview® Registry


  • Org Study ID: BLCCR-001
  • Secondary ID:
  • NCT ID: NCT02660645
  • NCT Alias:
  • Sponsor: Photocure - Industry
  • Source: Photocure

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 two (2) years on patients from
each enrolled site. Each center will enter their respective site's patient data
electronically.

Overal Status Start Date Phase Study Type
Recruiting Start Date: April 2014 N/A Observational [Patient Registry]

Primary Outcomes:

Primary Outcome 1 - Measure: Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.

Primary Outcome 1 - Time Frame: 2 years

Condition:

  • Bladder Cancer

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Siamek Daneshmand, MD

Role: Principal Investigator

Affiliation: University of Southern California

Overall Contact

Name: Yngvil Kloster Thomas

Phone: (216) 773-2505

Email: Ykt@photocure.com

Locations

Facility Status Contact
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Ileana Aldana
323-865-0702
ileana.aldana@med.usc.edu
University of Minnesota
Minneapolis, Minnesota 55455
United States
Recruiting Therese Perrier
612-625-3319
perri084@umn.edu
Carolina Urology Partners
West Columbia, South Carolina 29169
United States
Recruiting Nicol Brandon
704-414-2870
Nicol.brandon@carolinaurologypartners.com