Blue Light Cystoscopy With Cysview® Registry

Study Overview
=================
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. 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? 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? 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? 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? 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)? 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? Does an abnormal urinalysis help identify patients with inflammation more likely to have false positive Blue Light Cystoscopy with Cysview results? What is the practical learning curve for becoming proficient with Blue Light Cystoscopy with Cysview? What is the overall false positive rate with Blue Light Cystoscopy with Cysview? 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.

Official Title
-----------------
Blue Light Cystoscopy With Cysview® Registry

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Hexaminolevulinate hydrochloride (HCL)
* Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blue Light Cystoscopy with Cysview®<br>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. | Drug: Hexaminolevulinate hydrochloride (HCL)<br>* Instillation in bladder<br>* Other names: Hexvix®;Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system<br>* Cystoscopy procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of detection of bladder malignancies | Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False-positive detection rates | Rates of false-positive lesion biopsies based on pathological findings | 5 years | 
| Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone | Rate of additional margin detection with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone | 5 years | 
| Proportion of patients with adverse events considered causally related to Cysview in repeat administration. | Adverse events reporting | 5 years | 
| Recurrence Rates | Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview | 5 years | 
| Cystectomy Rate | Proportion of patients who have a cystectomy performed | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cysview, Hexaminolevulinate, Hexvix, NMIBC, BLCC, Blue Light Cystoscopy with Cysview, Cystoscopy, TURBT, TUR, Fluorescent cystoscopy, Non-muscle invasive bladder cancer (NMIBC), Transurethral resection (TUR)