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

RecruitingPhase 2Ages 18 Years - 75 YearsAllHenry Ford Health System
NCT06948552 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • 5-Aminolevulinic acid Hydrochloride (Gliolan®)
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Where

1 site
Henry Ford Hospital
Detroit, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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