Can Gleolan help highlight kidney tumors during partial nephrectomy?
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
Run by Henry Ford Health System · NCT07828704 · Data updated 2026-11-12
This study tests whether giving Gleolan before kidney surgery helps fluorescence identify cancer tissue in adults with suspected kidney cancer undergoing partial nephrectomy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Status | Recruiting |
| Started | September 15, 2026 |
| Main results expected | December 2027 |
| Study ends | January 2028 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07828704 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with kidney tumors suitable for standard partial nephrectomy and adequate organ function, who can give informed consent.
✕Probably not a fit
Patients with porphyria, porphyrin hypersensitivity, significant liver enzymes elevations, or any contraindication to 5-ALA may not benefit and could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm Phase 2 feasibility study evaluating the safety and practicality of using the imaging agent Gleolan (5-ALA) to visualize kidney cancer during partial nephrectomy. Adult participants with suspected kidney cancer will receive oral 5-ALA prior to surgery, then undergo partial nephrectomy with fluorescence guidance to see if tumor tissue lights up as hoped. Safety outcomes and any adverse events around the perioperative period will be collected, along with surgical feasibility and imaging performance. The trial aims to determine whether 5-ALA–induced fluorescence can improve tumor visualization and help assess resection margins without compromising patient safety.
Why it matters
Potential benefit: If successful, Gleolan-guided fluorescence could help surgeons better identify tumor tissue and margins during partial nephrectomy, potentially improving accuracy and outcomes.
How similar studies have gone: Prior use of 5-ALA for fluorescence-guided imaging in other cancers shows potential, but its use in kidney cancer is investigational and remains to be proven.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Henry Ford Health
Detroit, Michigan, United States Recruiting
Study contacts
- Principal investigator: Johar Raza, MD — Henry Ford Health
- Study coordinator: Peace Deh, MD
- Email: pdeh1@hfhs.org
- Phone: 313-916-7699
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.