Blue Light Cystoscopy With Cysview® Registry



Status:Recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2014
End Date:December 2017
Contact:Yngvil Kloster Thomas
Email:Ykt@photocure.com
Phone:(216) 773-2505

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

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.

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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