NCT06948552

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

A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Upper Urinary Tract Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

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 resection for suspected upper tract urothelial carcinoma (UTUC). 5-ALA is an FDA-approved oral agent used in glioma surgery to promote fluorescence of malignant tissue under blue light. This study will evaluate whether similar visualization can be achieved in the upper urinary tract to aid in the identification and resection of UTUC. Up to 10 participants will be enrolled. Safety, technical feasibility, and tumor detection outcomes will be measured.

Conditions

• Upper Tract Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	5-Aminolevulinic acid Hydrochloride (Gliolan®)	Participants will receive a single oral dose of 5-aminolevulinic acid (20 mg/kg) approximately 2 to 4 hours prior to surgery. The goal is to evaluate the feasibility of using fluorescence cystoscopy with blue light to improve tumor detection and visualization during ureteroscopic resection of upper tract urothelial carcinoma.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2025-04-29
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study