Recruiting PHASE2 Upper Tract Urothelial Carcinoma

New treatment option for Upper Tract Urothelial Carcinoma

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

ClinicalTrials.gov ID: NCT06948552

What this study is testing

What is 5-Aminolevulinic acid Hydrochloride (Gliolan®)?

5-Aminolevulinic acid Hydrochloride (Gliolan®) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for upper tract urothelial carcinoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • 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

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Detroit, Michigan, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.