Tests 5-ALA dye and blue light to spot upper urinary tract tumors
Tests a dye, 5-ALA, and blue light to spot urinary tract tumors.
Plain-language title generated from the registry record
Registry title: Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA
Key facts
- Where
- Detroit, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06948552, who can take part
Where in United States
- Henry Ford HospitalDetroit, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Henry Ford Health System
- Trial code
- NCT06948552
- Record updated
- 18 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Known porphyria or hypersensitivity to porphyrins; Known allergy or contraindication to 5-ALA or its components; AST or ALT > 2x upper limit of normal within 30 days prior to surgery; Pregnant or breastfeeding women; Participation in another investigational study within 30 days.