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5-ALA for Upper Tract Urothelial Carcinoma Detection

This study is looking at whether a medication called 5-aminolevulinic acid (5-ALA, also known as Gliolan®) can help doctors better see upper tract urothelial carcinoma (UTUC) during surgery. UTUC is a type of cancer that affects the lining of the upper urinary tract. If you are having surgery for a known or suspected UTUC, you might be able to join. Participants will take a single dose of 5-ALA before surgery. During surgery, doctors will use a special blue light to see if the 5-ALA makes the tumor glow, which could help them find and remove it more effectively. The main goal is to see if this method helps detect the tumor. This study is currently unclear on its recruitment status and plans to enroll up to 10 people.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It is a feasibility study, not yet assigned a phase, and plans to enroll up to 10 participants.
What's involved
You would receive a single oral dose of 5-aminolevulinic acid (20 mg/kg) approximately 2 to 4 hours prior to your scheduled surgery.
Compensation
Not stated in the trial record.
Follow-up
Tumor fluorescence detection is measured on the day of surgery. Further follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06948552

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

Recruiting
PHASE2Ages 18–75InterventionalDiagnostic
Henry Ford Health System
~10 participants
Updated 2026-09-18 on ClinicalTrials.gov
What's tested:5-Aminolevulinic acid Hydrochloride (Gliolan®)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection of tumor fluorescence using 5-ALA under blue light
Measured over Day of Surgery

Conditions

Upper Tract Urothelial Carcinoma

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Renal Pelvis and Ureter Urothelial Carcinoma

NCT06948552

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Henry Ford Hospital

    Detroit, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Johar Raza, MD · PRINCIPAL_INVESTIGATOR · Henry Ford Health

Who to contact

Peace Deh, MD
[email protected]
313-916-7699
Email the study team

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Eligibility criteria

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
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

What this trial measures

  • Detection of tumor fluorescence using 5-ALA under blue lightDay of Surgery

    Surgeons will assess whether upper tract urothelial tumors exhibit visible fluorescence under blue light following oral administration of 5-ALA (20 mg/kg). Presence or absence of fluorescence will be recorded for each lesion during ureteroscopic resection.