A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
- Conditions
- Bladder Cancer
- Interventions
- Device: KARL STORZ D-Light C PDD Flexible Videoscope System
- Registration Number
- NCT02560584
- Lead Sponsor
- Photocure
- Brief Summary
The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
Not provided
- Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy)
- Patients who cannot undergo in-office or operating room cystoscopy (Note: Training patients are eligible even if they cannot undergo operating room cystoscopy)
- Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure
- Porphyria
- Known allergy to hexaminolevulinate hydrochloride or a similar compound
- Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
- Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cysview arm Hexaminolevulinate hydrochloride In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure) All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours. Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System Cysview arm KARL STORZ D-Light C PDD Flexible Videoscope System In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure) All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours. Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System
- Primary Outcome Measures
Name Time Method Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy At time of cystoscopy procedure In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured.
- Secondary Outcome Measures
Name Time Method Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination At time of cystoscopy procedure Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy At time of cystoscopy procedure In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.
Trial Locations
- Locations (17)
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of North Carolina, Department of Urology
🇺🇸Chapel Hill, North Carolina, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Ohio State University The James Cancer Hospital
🇺🇸Columbus, Ohio, United States
NYU Langone Urology Associates
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Oklahoma-Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States