A prospective, open, comparative, within patient controlled multicenter phase 3 study of blue light cystoscopy with Cysview and white light cystoscopy using KARL STORZ D-Light C PDD Flexible Videoscope System in detection of bladder cancer in patients withbladder cancer
Sponsor: |
Photocure |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ0311 |
Contact: |
Joel DeCastro: 212-305-0114 / gid16@columbia.edu |
The purpose of the study is to investigate if Cysview and blue light is better than white light in detecting tumors in individuals with bladder cancer prior to and during surgery that are in follow-up for tumor recurrence. Cysview is an FDA approved drug that is used in combination with a lamp from KARL STORZ to detect tumors in the bladder (KARL STORZ D-Light C PDD System). The technique is called photodynamic diagnostic (PDD). Cysview is similar to a chemical found naturally in your body, called ALA. Cysview by itself is inactive (does not have any effect), but is changed to other substances (porphyrins) in the body. The lamp emits blue light and the tumors will glow red and are therefore easy to see for the doctor through the cystoscope. Since the production of porphyrins is much higher in cancer cells compared to normal cells, the tumors in the bladder will glow much stronger than normal cells.This study is randomized which means that some participants will receive white light and some people will receive blue light during their exam.Participants in this study will come in for three visits.
This study is closed
Investigator
Joel DeCastro, MD, MPH
have you been diagnosed with bladder cancer? |
Yes |
No |