RecruitingPhase 2NCT07223307

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

Sponsor

Stanford University

Enrollment

62 participants

Start Date

Jan 23, 2026

Study Type

INTERVENTIONAL

Conditions

Liver Cancer Liver Metastases Intrahepatic Cholangiocarcinoma HCC

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a highly precise form of radiation therapy called MRI-guided adaptive SABR (stereotactic ablative radiotherapy) for people with liver cancers, including primary liver cancer (hepatocellular carcinoma), bile duct cancer (cholangiocarcinoma), or cancer that has spread to the liver from elsewhere. The MRI guidance allows doctors to adjust the radiation in real time to better target the tumor. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of liver cancer or cancer spread to the liver - Your liver is still functioning reasonably well (Child-Pugh A status) - You are in reasonably good health and able to perform some daily activities (ECOG 0–2) - Your life expectancy is more than 6 months - You are able to hold your breath for more than 15 seconds **You may NOT be eligible if...** - You have previously received radioembolization (a type of liver radiation treatment using radioactive beads) - You have received chemotherapy or an experimental drug within the past week - You are pregnant - You have a pacemaker or other implanted device that is not compatible with MRI - Your tumor directly invades the stomach or bowel Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONMRI-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.