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NCT07828704RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
10 (estimated)
First submitted
29 Jul 2026
Start date
15 Sept 2026
Primary completion date
Dec 2027
Lead sponsor
Henry Ford Health System
NCT number
NCT07828704

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 10
  • From 15 Sept 2026 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known porphyria or hypersensitivity to porphyrins
  • Known allergy or contraindication to 5-ALA or its components

Lab values

  • AST or ALT \> 2x upper limit of normal within 30 days prior to surgery

Other

  • Pregnant or breastfeeding women
  • Participation in another investigational study within 30 days

Who the study is looking for

  • Patients aged 18 or older
  • Has indications for standard-of-care partial nephrectomy
  • Able to provide informed consent
  • Able to comply with study requirements

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Henry Ford Health
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.