Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA

Recruiting now · Phase 2

Conditions studied: Upper Tract Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT06948552

Run by

Henry Ford Health System

People needed

10

Starts

2026-08-01

Expected to finish

2028-01-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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