Study on Using Fluorescence Endoscopy and Oral 5-ALA for Diagnosing Kidney Cancer
Sponsor: Henry Ford Health System
ClinicalTrials ID:NCT07828704
This study is testing a new method to help surgeons see kidney cancer more clearly during surgery using a special drug called Gleolan and a type of light imaging. The goal is to see if this method is safe and effective for patients undergoing surgery to remove part of their kidney.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using Gleolan, a drug that helps highlight cancerous tissue, can improve the visibility of kidney tumors during surgery. Gleolan is already used in brain tumor surgeries and may help surgeons better identify kidney cancer. The study will check if Gleolan is safe and if it can be used effectively to guide surgeons in identifying cancerous areas during kidney surgery.
Description
This study is exploring the use of a drug called 5-aminolevulinic acid (5-ALA), also known as Gleolan, to help surgeons see kidney tumors more clearly during surgery. Gleolan is taken orally before surgery and makes cancer cells glow under a special blue light, which can help surgeons identify and remove tumors more accurately. The study will involve 10 adult patients who need surgery to remove part of their kidney due to suspected cancer. Participants must be in good health and able to undergo surgery safely. They will take Gleolan before their operation and will be monitored for any side effects. During surgery, doctors will use a special light to see if the tumors glow, which can help them ensure all cancerous tissue is removed. The study aims to see if this method can improve tumor detection and ensure safe surgery with minimal side effects. If successful, this approach could lead to larger studies and potentially become a standard practice for kidney cancer surgeries.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older
- Scheduled for partial kidney removal surgery
- Able to understand and agree to the study
- Willing to follow study procedures
Exclusion Criteria
- Known sensitivity to porphyrins or related conditions
- Pregnant or nursing women
- Liver enzyme levels more than twice the normal limit
- Participation in another study within the last 30 days
- Allergy to 5-ALA or its ingredients
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Henry Ford Health | 48202 | Detroit | Michigan |
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