Status:
NOT_YET_RECRUITING
Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA
Lead Sponsor:
Henry Ford Health System
Conditions:
Upper Tract Urothelial Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 durin...
Detailed Description
This is a prospective, single-arm feasibility study investigating the use of 5-aminolevulinic acid (5-ALA, Gleolan) to enhance intraoperative tumor visualization in patients undergoing ureteroscopic r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06948552
Start Date
May 1 2025
End Date
March 1 2026
Last Update
April 29 2025
Active Locations (1)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202