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Radioembolization Versus External Radiation Therapy

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* Ability to provide written informed consent and HIPAA authorization
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years at time of informed consent
* No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board
* Childs-Pugh score ≤ 8
* ECOG performance status ≤2
* Adequate organ function defined as:
* serum bilirubin \< 4.0 mg/dL ,
* albumin \> 2 g/dL

Exclusion Criteria:

* Any prior SBRT or radioembolization to the target tumor
* 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 of protocol registration.
* Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy

About the study

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.

What is being tested

• Transarterial Radioembolization (radiation)
• Stereotactic Body Radiation Therapy (SBRT) (radiation)

Sponsor: Henry Ford Health System · Participants: 146 · Started: Dec 8, 2025

Contact the study team

• Marissa Gilbert · Phone: 313-556-8422

Official record on ClinicalTrials.gov — NCT07530172

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.