MRI-guided adaptive single-session radiation for liver tumors (SABR)
Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow
PHASE2 · Stanford University · NCT07223307
This trial will test a single-session, MRI-guided adaptive high-dose radiation (SABR) for adults with primary or metastatic liver tumors to see if on-table MRI planning and replanning can treat tumors without a separate simulation visit.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT07223307 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with HCC, intrahepatic cholangiocarcinoma, or liver metastases who have Child-Pugh A liver function, ECOG 0–2, and an expected survival over six months are ideal candidates.
Not a fit: Patients with poorer liver function (Child-Pugh B or C), extensive uncontrolled extrahepatic disease, or those who require fractionated radiation or have had prior radioembolization may not benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could allow precise, high-dose liver tumor treatment in one visit with fewer clinic visits and potentially lower collateral liver exposure.
How similar studies have performed: MR-guided and adaptive SABR approaches for abdominal and liver tumors have shown promising early results in improving targeting and sparing normal tissue, but a simulation-free, single-session adaptive workflow remains relatively novel and is under active study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (RECRUITING)
Study contacts
- Study coordinator: Eleanor Brown
- Email: eleanor9@stanford.edu
- Phone: 650-497-8966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cancer, Intrahepatic Cholangiocarcinoma, Liver Metastases, HCC