Photodynamic Diagnosis of Kidney Cancer Using Fluorescence Endoscopy and Oral 5-ALA

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT07828704
Phase
PHASE2
Status
Recruiting
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Conditions

  • Kidney Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 5-Aminolevulinic acid Hydrochloride (Gliolan®) — DRUG
    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:

Study Details

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.

Key Dates

First listed
Sep 18, 2026
Start date
Sep 15, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
Johar Raza, MD
[email protected]
313-585-0578

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By research site
Henry Ford Health· Detroit, MI

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