NCT07828704 Photodynamic Diagnosis of Kidney Cancer Using Fluorescence Endoscopy and Oral 5-ALA
| NCT ID | NCT07828704 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henry Ford Health System |
| Condition | Kidney Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-09-15 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2026-09-15 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Johar Raza, MD
PRINCIPAL INVESTIGATOR
Henry Ford Health
Frequently Asked Questions
Who can join the NCT07828704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Kidney Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07828704 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07828704 currently recruiting?
Yes, NCT07828704 is actively recruiting participants. Contact the research team at pdeh1@hfhs.org for enrollment information.
Where is the NCT07828704 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT07828704 clinical trial?
NCT07828704 is sponsored by Henry Ford Health System. The principal investigator is Johar Raza, MD at Henry Ford Health. The trial plans to enroll 10 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.