Fluorescence detection of upper tract urothelial carcinoma with oral 5-ALA during ureteroscopy
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
PHASE2 · Henry Ford Health System · NCT06948552
This study tests whether taking oral 5-ALA before ureteroscopy helps surgeons use blue-light fluorescence to see and remove upper tract urothelial tumors in adults having ureteroscopic tumor resection.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Henry Ford Health System (other) |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT06948552 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm phase 2 feasibility study at a single center enrolling up to 10 adults undergoing diagnostic or therapeutic ureteroscopy for suspected upper tract urothelial carcinoma. Participants will receive oral 5-aminolevulinic acid (5-ALA, Gliolan) before surgery and surgeons will use blue-light fluorescence endoscopy in addition to standard white light to look for abnormal tissue. The study will record technical feasibility, tumor detection rates under fluorescence versus white light, and safety outcomes related to 5-ALA. Results will inform whether fluorescence guidance can be applied to upper urinary tract tumor detection and guide larger future studies.
Who should consider this trial
Good fit: Adults aged 18 or older who are able to consent and are scheduled for diagnostic or therapeutic ureteroscopy for a known or suspected upper tract urothelial tumor are eligible.
Not a fit: Patients with known porphyria, allergy to 5-ALA, pregnancy or breastfeeding, marked liver enzyme elevations, or who cannot undergo ureteroscopy are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the technique could help surgeons find and remove more tumors during ureteroscopy, potentially reducing missed lesions and the need for repeat procedures.
How similar studies have performed: Oral 5-ALA is FDA-approved for glioma fluorescence and similar fluorescence agents have improved tumor detection in bladder cancer, but its use in the upper urinary tract is much less tested and this study is exploratory.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Detroit, Michigan
- Henry Ford Hospital — Detroit, Michigan, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Upper Tract Urothelial Carcinoma, Photodynamic Diagnosis, 5-ALA, Gleolan, Ureteroscopy, Fluorescence Endoscopy, Urothelial Cancer, Blue Light