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Recruiting Phase 2 NCT06948552

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

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Trial Parameters

Condition Upper Tract Urothelial Carcinoma
Sponsor Henry Ford Health System
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2026-04
Completion 2027-12
Interventions
5-Aminolevulinic acid Hydrochloride (Gliolan®)

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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.

Eligibility Criteria

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

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