NCT07223307

REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers

Conditions

• Liver Cancer
• Intrahepatic Cholangiocarcinoma
• Liver Metastases
• HCC

Interventions

Type	Name	Description
RADIATION	MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)	A single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) will be delivered using the MRIdian system. Treatment includes adaptive planning based on daily MRI imaging to update tumor and organ-at-risk contours and optimize the radiation dose. On the day of treatment, Eovist contrast is administered 20 minutes before therapy to enhance tumor visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. The total dose is 30-40 Gy delivered in one fraction using external beam techniques.

Timeline

• Start date: 2026-01-23
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2025-10-31
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study