Comparing targeted Y-90 radioembolization with focused external SBRT for liver cancer
Official title: Radioembolization Versus External Radiation Therapy
Run by Henry Ford Health System · NCT07530172 · Data updated 2026-11-12
This trial tests whether Y-90 transarterial radioembolization or focused stereotactic body radiation (SBRT) better controls hepatocellular carcinoma lesions in adults eligible for either treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 146 (estimated) |
| Sponsor | Henry Ford Health System Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Detroit, Michigan) |
| Status | Recruiting |
| Started | December 8, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT07530172 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with up to three hepatocellular carcinoma lesions considered suitable for either TARE or SBRT, Child-Pugh ≤8, ECOG ≤2, and adequate liver function (bilirubin <4.0 mg/dL, albumin >2 g/dL) are ideal candidates.
✕Probably not a fit
Patients with macrovascular invasion, prior SBRT or radioembolization to the target lesion, planned systemic consolidation therapy, pregnancy/lactation, or severe contrast allergy/coagulopathy are excluded and unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-site, randomized phase 2 trial at Henry Ford Health System compares transarterial radioembolization (TARE) using selective Yttrium-90 delivery to stereotactic body radiation therapy (SBRT) delivered in 3–5 fractions. Patients with up to three HCC lesions who meet liver function and performance status criteria are randomized to either a planning arteriogram with segmental Y-90 infusion (dose prescribed to deliver ≥200 Gy to perfused tissue) or standard SBRT with dose adjusted for safety. The primary endpoint is the rate of re-treatment of the index lesion within 12 months, with safety and tolerability monitored throughout. Key eligibility limits include Child-Pugh score ≤8, ECOG ≤2, no macrovascular invasion, and no prior SBRT or radioembolization to the target.
Why it matters
Potential benefit: If successful, the trial could identify the approach that reduces the need for repeat procedures and improves local control of liver tumors with acceptable safety.
How similar studies have gone: Both Y-90 radioembolization and SBRT have shown local control in prior single-arm and comparative studies, but randomized head-to-head data are limited, so this direct comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Henry Ford Health System
Detroit, Michigan, United States Recruiting
Study contacts
- Principal investigator: Reena Salgia, MD — Henry Ford Health System
- Study coordinator: Marissa Gilbert
- Email: mgilber6@hfhs.org
- Phone: 313-556-8422
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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.