MRI-guided adaptive single-session radiation for liver tumors (SABR)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, unblinded Phase 2 trial delivering simulation-free, MRI-guided stereotactic ablative body radiotherapy (SABR) with adaptive replanning during one treatment session for patients with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases. Treatment planning and tumor targeting use real-time MR imaging on the treatment table so the radiation plan can be adapted immediately before or during the single high-dose session. Eligible patients are adults with preserved liver function (Child-Pugh A), ECOG performance status 0–2, and life expectancy over six months; prior liver-directed therapies are allowed except radioembolization. The trial is conducted at Stanford University using an MR-guided radiotherapy platform provided in collaboration with ViewRay Inc.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed HCC, intrahepatic cholangiocarcinoma, or metastatic cancer. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases (lesion \> 1 cm with arterial phase hyperenhancement and venous phase washout) or LI-RADS score of 5 may be used
* ≥ 18 years old at time of study enrollment
* Child-Pugh A status
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life Expectancy \> 6 months
* For women of childbearing potential or who are not postmenopausal (see Appendix F for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done.
* Ability to understand and the willingness to provide written informed consent.
* Patients treated with prior liver-directed therapies with the exception of radioembolization are eligible for this study if they otherwise meet eligibility criteria

Exclusion Criteria:

* Prior treatment with radioembolization
* Cytotoxic chemotherapy or investigational agent within 1 week of SABR
* Prior radiotherapy overlapping with study treatment site
* Female patients who are pregnant
* Contraindication to having an MRI scan or inability to tolerate MRI
* Presence of a pacemaker or other implanted cardiac device
* Direct tumor extension into the stomach, duodenum, small bowel or large bowel
* Patient unable to breath hold \> 15 seconds

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Eleanor Brown
• Email: eleanor9@stanford.edu
• Phone: 650-497-8966

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.