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

Conditions

• Upper Tract Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 5-Aminolevulinic acid Hydrochloride (Gliolan®) — DRUG
  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.

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Apr 2025

Primary completion

Dec 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: 5-ALA Fluorescence Imaging
  Participants will receive a single oral dose of 5-aminolevulinic acid (5-ALA, Gleolan) 2-4 hours prior to ureteroscopic tumor resection. Blue light endoscopy will be used intraoperatively to assess tumor fluorescence and aid in visualization and resection.

Primary Outcome Measure

Detection of tumor fluorescence using 5-ALA under blue light [ Time Frame: Day of Surgery ]

Locations (1)

Find similar trials in Detroit, MI

Related Studies

• A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial
  Recruiting · University of Washington · Seattle, Washington