A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting

Completed · Phase 3

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT02560584

Run by

Photocure

People needed

304

Starts

2015-10-01

Expected to finish

2017-04-05

Last updated by the study team

2018-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• NYU Langone Urology Associates — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of North Carolina, Department of Urology — Chapel Hill, North Carolina, United States
• Ohio State University The James Cancer Hospital — Columbus, Ohio, United States
• University of Oklahoma-Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Michael E. DeBakey VA Medical Center — Houston, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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