REGULUS: MRI-guided Adaptive SABR for Liver Cancers
NCT07223307 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-02-09
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
- 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.
Sponsors & Collaborators
-
Viewray Inc.
collaborator INDUSTRY - lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-23
- Primary Completion
- 2030-01-31
- Completion
- 2030-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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