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NCT06948552RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
10 (estimated)
First submitted
22 Apr 2025
Start date
Sept 2026
Primary completion date
Dec 2027
Lead sponsor
Henry Ford Health System
NCT number
NCT06948552

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 10
  • From Sept 2026 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known porphyria or hypersensitivity to porphyrins
  • Known allergy or contraindication to 5-ALA or its components

Lab values

  • AST or ALT \> 2x upper limit of normal within 30 days prior to surgery

Other

  • Pregnant or breastfeeding women
  • Participation in another investigational study within 30 days

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Henry Ford Hospital
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.