Study on Using Fluorescence Endoscopy and Oral 5-ALA to Detect Upper Tract Urothelial Cancer

Sponsor: Henry Ford Health System

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06948552

Provider View

This clinical trial is testing whether a medication called 5-ALA can help doctors see upper tract urothelial tumors more clearly during surgery. Patients will take 5-ALA before their procedure, and surgeons will use a special blue light to spot abnormal tissue that might be missed with regular lighting.

Patient Parameters

Program Overview

The purpose of this study is to find out if a medication called 5-aminolevulinic acid (5-ALA) can improve the visibility of tumors in the upper urinary tract during surgery. 5-ALA is already approved for use in brain surgery to help highlight cancerous tissue. In this study, patients undergoing surgery to remove suspected upper tract urothelial carcinoma (UTUC) will take 5-ALA before the procedure. Surgeons will then use a special blue light to help identify and remove tumors that might not be visible with standard lighting. The study aims to see if this method can improve tumor detection and removal.

Description

This study is testing a new way to help surgeons see tumors more clearly during surgery for upper tract urothelial carcinoma (UTUC). The study uses a medication called 5-aminolevulinic acid (5-ALA), which is taken by mouth before surgery. 5-ALA is already used in brain surgery to make cancerous tissue glow under blue light. In this study, surgeons will use the same technique to try to see UTUC tumors more clearly. Up to 10 patients will participate in this study. Researchers will look at how safe the method is, how well it works, and whether it helps find and remove tumors more effectively.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 18 or older who are having a procedure to diagnose or treat a suspected upper tract urothelial tumor
  • Able to understand and agree to the study by signing a consent form
  • Willing to follow the study requirements

Exclusion Criteria

  • Have a condition called porphyria or are allergic to porphyrins
  • Are pregnant or breastfeeding
  • Have liver enzyme levels (AST or ALT) more than twice the normal limit within 30 days before surgery
  • Are participating in another study within the last 30 days
  • Have an allergy or cannot take 5-ALA or its ingredients

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