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Photodynamic Diagnosis of Kidney Cancer Using Fluorescence Endoscopy and Oral 5-ALA
Sponsor: Henry Ford Health System
Summary
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.
Official title: A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Kidney Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-09-15
Completion Date
2028-01
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
5-Aminolevulinic acid Hydrochloride (Gliolan®)
Participants will receive a single oral dose of 5-aminolevulinic acid (20 mg/kg) approximately 2 to 4 hours prior to surgery. The goal is to evaluate the feasibility of using fluorescence cystoscopy with blue light to improve tumor detection and visualization during ureteroscopic resection of upper tract urothelial carcinoma. Other Name:
Locations (1)
Henry Ford Health
Detroit, Michigan, United States