Brief Summary
Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
Brief Title
Blue Light Cystoscopy With Cysview® Registry
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(919) 780-0417
Central Contact Email
chad.mckee@photocure.com
Completion Date
Completion Date Type
Estimated
Conditions
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Adult \>18 years old
* Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy
* Adult \>18 years old
* Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy
Gender
All
Gender Based
false
Keywords
Cysview
Hexaminolevulinate
Hexvix
NMIBC
BLCC
Blue Light Cystoscopy with Cysview
Cystoscopy
TURBT
TUR
Fluorescent cystoscopy
Non-muscle invasive bladder cancer (NMIBC)
Transurethral resection (TUR)
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02660645
Org Class
Industry
Org Full Name
Photocure
Org Study Id
BLCCR-001
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Blue Light Cystoscopy With Cysview® Registry
Primary Outcomes
Outcome Description
Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.
Outcome Measure
Rate of detection of bladder malignancies
Outcome Time Frame
5 years
Secondary Outcomes
Outcome Description
Rates of false-positive lesion biopsies based on pathological findings
Outcome Time Frame
5 years
Outcome Measure
False-positive detection rates
Outcome Description
Rate of additional margin detection with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone
Outcome Time Frame
5 years
Outcome Measure
Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone
Outcome Description
Adverse events reporting
Outcome Time Frame
5 years
Outcome Measure
Proportion of patients with adverse events considered causally related to Cysview in repeat administration.
Outcome Description
Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview
Outcome Time Frame
5 years
Outcome Measure
Recurrence Rates
Outcome Description
Proportion of patients who have a cystectomy performed
Outcome Time Frame
5 years
Outcome Measure
Cystectomy Rate
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients indicated for transurethral resection of the bladder.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joshua Stern
Investigator Email
jstern@montefiore.org
Investigator Phone
718-920-4531