Phase II Study of Oral 5-Aminolevulinic Acid to Improve Tumor Detection Using Blue Light Fluorescence During Ureteroscopic Surgery for Upper Tract Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating whether 5-aminolevulinic acid 5-ALA, an FDA-approved medication used in brain surgery, can improve the visibility of upper tract urothelial tumors during ureteroscopic tumor resection. This study focuses on using 5-ALA to help surgeons better identify and remove abnormal tissue in patients with suspected upper tract urothelial carcinoma UTUC. It is a phase 2, single-group diagnostic study assessing the feasibility and safety of this technique. Participants will receive a single oral dose of 5-ALA approximately 2 to 4 hours before surgery. During the ureteroscopic tumor resection, surgeons will use special blue light endoscopy to detect tumor fluorescence, which may highlight cancerous tissue not visible under standard white light. This approach aims to enhance tumor detection and guide resection during the procedure. Participants will undergo ureteroscopic surgery with 5-ALA administration and blue light imaging on the day of surgery. Researchers will assess tumor fluorescence during surgery and monitor for any adverse effects for up to 30 days afterward. Follow-up ureteroscopy within 3 months will check for any remaining tumor. The study plans to enroll up to 10 participants and will evaluate safety, technical feasibility, and tumor detection outcomes.

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