Recruiting
Phase 2

Gleolan

Sponsor:

Henry Ford Health System

Code:

NCT07828704

Conditions

Kidney Cancers

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

5-Aminolevulinic acid Hydrochloride (Gliolan®)

Study Details

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.

Conditions

Kidney Cancers

Study ID

NCT07828704

Start date

Sep 15, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 5-ALA Fluorescence Imaging

Participants will receive a single oral dose of 5-aminolevulinic acid (5-ALA, Gleolan) 2-4 hours prior to ureteroscopic tumor resection. Blue light endoscopy will be used intraoperatively to assess tumor fluorescence and aid in visualization and resection.

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:

Primary outcome measure

  • Detection of tumor fluorescence using 5-ALA under blue light [ Time Frame: Intra-operatively ]

Central Contacts and Locations

Central contacts

Peace Deh, MD

313-916-7699pdeh1@hfhs.org

Locations

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Johar Raza, MD

313-585-0578jraza1@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Sep 18, 2026

Last verified

Jul, 2026

Keywords

  • 5-Aminolevulinic Acid (5-ALA)
  • Gleolan
  • Kidney Cancer
  • Partial Nephrectomy
  • Photodynamic Diagnosis
  • Fluorescence-Guided Surgery
  • Renal Cell Carcinoma
  • Minimally Invasive Surgery
  • Urologic Oncology
  • Blue Light

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.