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

What this Trial Is About

Researchers are evaluating whether 5-aminolevulinic acid (5-ALA), a medication approved by the FDA for brain surgery, can improve the visibility of tumors in the upper urinary tract during surgery. The study focuses on patients with suspected upper tract urothelial carcinoma (UTUC) undergoing ureteroscopic tumor resection. The purpose is to assess if using 5-ALA with special blue light can help surgeons better detect and remove tumors. Participants will receive a single oral dose of 5-ALA about 2 to 4 hours before surgery. During the procedure, surgeons will use blue light endoscopy to see the tumor fluorescence and aid in identifying abnormal tissue that may not be visible under normal white light. This is a single-arm feasibility study enrolling up to 10 participants to evaluate safety, technical feasibility, and tumor detection. During the study, participants will undergo ureteroscopic tumor removal with fluorescence imaging. Researchers will monitor tumor fluorescence during surgery, check for adverse events up to 30 days after the procedure, and assess for residual tumors at follow-up ureteroscopy up to 3 months later. The total participation period includes the surgery day and follow-up visits to ensure safety and evaluate outcomes.

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