Home › Kidney Cancer › NCT07828704
Photodynamic Diagnosis of Kidney Cancer Using Fluorescence Endoscopy and Oral 5-ALA
A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Kidney Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients aged 18 or older * Has indications for standard-of-care partial nephrectomy * Able to provide informed consent * Able to comply with study requirements Exclusion Criteria: * Known porphyria or hypersensitivity to porphyrins * Pregnant or breastfeeding women * AST or ALT \> 2x upper limit of normal within 30 days prior to surgery * Participation in another investigational study within 30 days * Known allergy or contraindication to 5-ALA or its components
About the study
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.
What is being tested
- 5-Aminolevulinic acid Hydrochloride (Gliolan®) (drug)
Sponsor: Henry Ford Health System · Participants: 10 · Started: Sep 15, 2026
Contact the study team
- Peace Deh, MD · Phone: 313-916-7699
Official record on ClinicalTrials.gov — NCT07828704
Locations in the U.S.
| Michigan | Henry Ford Health, Detroit |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.