Actively Recruiting
Radioembolization Versus External Radiation Therapy
Led by Henry Ford Health System · Updated on 2026-04-15
146
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.
CONDITIONS
Official Title
Radioembolization Versus External Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent and HIPAA authorization
- Willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older at time of informed consent
- No more than 3 lesions of hepatocellular carcinoma eligible for TARE or SBRT as determined by a tumor board
- Childs-Pugh liver function score of 8 or less
- ECOG performance status of 2 or less
- Adequate organ function with serum bilirubin less than 4.0 mg/dL and albumin greater than 2 g/dL
You will not qualify if you...
- Any prior stereotactic body radiation therapy or radioembolization to the target tumor
- Presence of macrovascular invasion
- Planned or recommended systemic therapy as consolidation
- Pregnancy or lactation; women of childbearing potential must have a negative pregnancy test within 14 days before enrollment
- Known severe allergic reaction (anaphylaxis) to iodinated contrast
- Coagulopathy considered unsafe for transarterial therapy by the provider
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
M
Marissa Gilbert
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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