Oral 5-ALA for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this prospective, single-arm feasibility study is to evaluate the safety and feasibility of using Gleolan® (5-aminolevulinic acid), an FDA-approved drug currently used during brain tumor surgery, in adults with suspected kidney cancer undergoing partial nephrectomy. Gleolan has shown promise in improving the visualization of cancerous tissue, and this study aims to assess its potential use in urologic oncology. The main questions it aims to answer are:
* Is Gleolan safe and well tolerated in patients with suspected kidney cancer undergoing partial nephrectomy?
* Is the use of Gleolan feasible for fluorescence-guided identification of kidney cancer lesions during surgery?
Participants will:
* Receive Gleolan before surgery according to the study protocol.
* Undergo partial nephrectomy, during which fluorescence imaging will be used to evaluate the visualization of kidney tumor tissue.
* Be monitored for safety outcomes and any adverse events before, during, and after surgery.
Who Is on the Research Team?
Johar Raza, MD
Principal Investigator
Henry Ford Health
Are You a Good Fit for This Trial?
This trial is for adults with suspected kidney cancer who are scheduled to have part of their kidney removed (partial nephrectomy).Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- 5-Aminolevulinic acid Hydrochloride (Gliolan®)
Trial Overview
The study tests if taking Gleolan (5-ALA) by mouth before surgery helps doctors see kidney tumors better using special fluorescent imaging during the operation. All participants receive the drug and undergo this imaging.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive a single oral dose of 5-aminolevulinic acid (5-ALA, Gleolan) 2-4 hours prior to ureteroscopic tumor resection. Blue light endoscopy will be used intraoperatively to assess tumor fluorescence and aid in visualization and resection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor
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