NCT07530172

Radioembolization Versus External Radiation Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Heptocellular Cancer

Interventions

Type	Name	Description
RADIATION	Transarterial Radioembolization	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.
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	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.

Timeline

• Start date: 2025-12-08
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States