Study on Blue Light Surgery for High-Risk Non-Muscle Invasive Bladder Cancer
Sponsor: Johns Hopkins University
ClinicalTrials ID:NCT06525571
This clinical trial is comparing two types of surgery, using white light and blue light, to see which is better at removing bladder cancer and preventing it from coming back. The study aims to find out if blue light can help doctors see and remove cancer more accurately.
Patient Parameters
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Program Overview
The study is investigating whether using blue light during bladder cancer surgery can help doctors remove cancer more effectively than the traditional white light method. This could lead to fewer cancer cells left behind and lower chances of the cancer returning. Patients will be randomly assigned to have surgery with either white light or blue light. The success of the surgeries will be measured by checking for remaining cancer cells and monitoring patients over time to see if the cancer comes back.
Description
The main goal of this study is to compare how well blue light and white light surgeries reduce the amount of cancer left in the bladder. This will be done by analyzing urine samples before and after surgery to see how many cancer cells remain. The study will also look at how long patients stay free of cancer after surgery, checking at 12 and 24 months. For patients receiving additional bladder treatments, the study will also track their cancer-free survival at these same time points.
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for bladder surgery due to a positive tumor found on scans or cystoscopy.
- Must be 18 years or older.
- The upper urinary tract will be checked as part of standard care during the study.
- Additional bladder treatment should start within four weeks after surgery.
Exclusion Criteria
- Less than 50% of the tumor is the common type of bladder cancer.
- History or current diagnosis of cancer in the upper urinary tract or muscle-invasive bladder cancer.
- Previous pelvic radiation treatment.
- Active urinary tract infection.
- Patients who cannot follow the study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sibley Memorial Hospital | 20016 | Washington | District of Columbia |
| Johns Hopkins University School of Medicine | 21287 | Baltimore | Maryland |
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