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

Launched by HENRY FORD HEALTH SYSTEM · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called 5-aminolevulinic acid (5-ALA) can make it easier for doctors to see and remove tumors in the upper urinary tract during surgery. 5-ALA has been approved by the FDA for use in brain surgery, but researchers want to see if it can also help with bladder and kidney tumors. Patients who are scheduled for a type of surgery called ureteroscopy will take 5-ALA before their procedure. Doctors will then use a special blue light to help spot any abnormal tissues that might be missed with regular lighting.

To participate in this study, patients must be 18 years or older and have a known or suspected tumor in the upper urinary tract that requires surgery. They should also be able to give their consent and follow the study guidelines. However, not everyone can join. For example, people with certain medical conditions or those who are pregnant or breastfeeding cannot participate. This trial is not yet recruiting participants, but it aims to improve how doctors detect and treat these types of tumors, potentially leading to better outcomes for patients.

Gender

ALL

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