Fluorescence detection of upper tract urothelial carcinoma with oral 5-ALA during ureteroscopy
Official title: 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
Run by Henry Ford Health System · NCT06948552 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Status | Recruiting |
| Started | September 15, 2026 |
| Main results expected | December 2027 |
| Study ends | January 2028 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT06948552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Henry Ford Hospital
Detroit, Michigan, United States Recruiting
Study contacts
- Principal investigator: Johar Raza, MD — Henry Ford Health
- Study coordinator: Peace Deh, MD
- Email: pdeh1@hfhs.org
- Phone: 313-916-7699
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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A noninvasive urine test is being used to see if it can correctly identify urothelial cancer in adults who have blood in urine and a suspicious imaging finding.
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Flexible ureteroscopy to monitor upper tract urothelial carcinoma
A small, forward-looking study will test whether doing flexible ureteroscopy under local anesthesia is safe and feasible for people who have had kidney-sparing treatment for upper tract urothelial carcinoma.
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Disitamab Vedotin Plus Radiotherapy for HER2-Expressing Upper Tract Urothelial Carcinoma After Surgery
This study tests whether disitamab vedotin with radiotherapy can improve outcomes for people with HER2-expressing upper tract urothelial carcinoma after radical surgery who can’t receive cisplatin.
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Dual-target Nectin-4 and HER2 CAR-NK therapy for advanced urothelial carcinoma
This treatment will try dual-target CAR-NK cells that recognize Nectin‑4 and HER2 in adults with relapsed or metastatic urothelial carcinoma after standard therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.