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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 5-Aminolevulinic acid Hydrochloride (Gliolan®)

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators