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

Sponsor: Henry Ford Health System

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06948552

Patient View

This study assesses the use of 5-ALA to enhance tumor visualization during ureteroscopic resection of suspected UTUC. Up to 10 participants, aged 18 or older, will receive 5-ALA before surgery. The study will evaluate safety, feasibility, and tumor detection outcomes using fluorescence cystoscopy with blue light. Participants must provide informed consent and comply with study requirements.

Patient Parameters

Program Overview

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.

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.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

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