Recruiting
Phase 2

5-ALA

Sponsor:

Henry Ford Health System

Code:

NCT06948552

Conditions

Upper Tract Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

5-Aminolevulinic acid Hydrochloride (Gliolan®)

Study Details

Brief summary:

This study is evaluating whether a medication called 5-aminolevulinic acid (5-ALA), approved by the FDA for use in brain surgery, can help improve the visibility of upper tract urothelial tumors during surgery. Patients undergoing ureteroscopic tumor resection will receive 5-ALA prior to surgery, and surgeons will use special blue light to help identify abnormal tissue that might not be seen under standard white light. The goal is to assess whether this technique can enhance tumor detection and removal.

Conditions

Upper Tract Urothelial Carcinoma

Study ID

NCT06948552

Start date

Aug, 2026

Status verified date

Jul, 2025

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 undergoing diagnostic or therapeutic ureteroscopy for a known or suspected upper tract urothelial tumor
  • 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.

Primary outcome measure

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

Central Contacts and Locations

Locations

Henry Ford Hospital

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

Jul 30, 2026

Last verified

Jul, 2025

Keywords

  • Photodynamic Diagnosis
  • 5-ALA
  • Gleolan
  • Ureteroscopy
  • Fluorescence Endoscopy
  • Urothelial Cancer
  • Blue Light
  • Kidney Cancer
  • Urologic Oncology
  • Minimally Invasive Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-07-30.