MRI-guided Adaptive SABR for Liver Cancer

Overseen By Eleanor Brown

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Pregnancy, Pacemaker, Prior radioembolization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment called MRI-guided adaptive SABR (stereotactic ablative body radiotherapy) for individuals with liver cancer. The treatment uses MRI scans to target the cancer more precisely and minimize damage to surrounding healthy tissue. The trial seeks participants with confirmed liver cancer who can hold their breath for more than 15 seconds during treatment. Participants should not have undergone specific previous treatments like radioembolization and must be able to have an MRI scan. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had cytotoxic chemotherapy or investigational agents within 1 week of the treatment.

What prior data suggests that this MRI-guided adaptive SABR is safe for liver cancer treatment?

Research has shown that MRI-guided adaptive SABR, a type of targeted radiation treatment, is generally safe and well-tolerated for liver tumors. In studies, patients treated with this method reported few serious side effects. One study found that MRI-guided SBRT, a specific form of SABR, was safe for patients with liver metastases, causing few severe health issues. Another study demonstrated that this treatment allows doctors to target the tumor with higher doses while protecting healthy tissue, reducing side effects. Overall, MRI-guided adaptive SABR appears to be a promising and safe option for treating liver cancers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MRI-guided adaptive SABR for liver cancer because it offers a cutting-edge way to target tumors more precisely. Unlike traditional radiation therapies, this treatment uses real-time MRI guidance to adapt the radiation plan each day, which helps deliver the maximum dose to the tumor while sparing healthy tissue. Additionally, the use of Eovist contrast enhances visualization of the liver, and the requirement for patients to hold their breath during radiation delivery minimizes motion, potentially increasing the accuracy and effectiveness of the treatment.

What evidence suggests that MRI-guided adaptive SABR is effective for liver cancer?

Research has shown that MRI-guided adaptive SABR, the treatment under study in this trial, holds promise for treating liver cancer. One study found that patients with liver tumors treated with this method experienced good local control, meaning the tumor did not regrow in the treated area. Another study highlighted that this technique targets the tumor more precisely, helping to protect healthy liver tissue. This method uses MRI to adjust the treatment daily, ensuring the radiation effectively targets the cancerous area. Overall, early findings suggest this treatment could be effective for liver cancer, particularly for those unable to undergo surgery. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with a life expectancy over 6 months and confirmed liver cancers, including hepatocellular carcinoma or metastatic cancer. They must be able to consent, have Child-Pugh A status, an ECOG score of 0-2, and not be pregnant. Exclusions include MRI contraindications, implanted cardiac devices, previous radiotherapy in the treatment area, inability to hold breath >15 seconds, prior radioembolization or recent chemotherapy.

Inclusion Criteria

Life Expectancy > 6 months

Ability to understand and the willingness to provide written informed consent

My cancer is confirmed and fits one of the specific types mentioned.

Exclusion Criteria

Contraindication to having an MRI scan or inability to tolerate MRI

Presence of a pacemaker or other implanted cardiac device

I have had radiotherapy in the same area where the study treatment is planned.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) with daily adaptive planning and Eovist contrast administration

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including overall survival and adverse events

1 year

What Are the Treatments Tested in This Trial?

Interventions

• MRI-guided adaptive SABR

Trial Overview The REGULUS trial tests MRI-guided adaptive SABR (a type of precise radiation therapy) in one session for treating various liver cancers without prior simulation. It's a single-arm study where all participants receive this intervention and their treatment plan may be adjusted during the session based on real-time imaging.

How Is the Trial Designed?

Group I: MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR) Experimental Treatment 1 Intervention

Participants will receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) using the MRIdian system. Treatment includes daily adaptive planning based on MRI to optimize dose delivery to the tumor and minimize dose to surrounding normal tissue. Eovist contrast is administered before treatment to enhance visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Viewray Inc.

Industry Sponsor

Trials

13

Recruited

1,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10334127/

Clinical outcomes of patients with unresectable primary liver ... Clinical outcomes of patients with unresectable primary liver cancer treated with MR-guided stereotactic body radiation Therapy: A Six-Year ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025002127

Liver Metastases Treated With Magnetic Resonance ... Stereotactic body radiation therapy (SBRT) is a local treatment option for liver metastases. The introduction of magnetic resonance imaging ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.160

Outcomes of simultaneous, adaptive, MRI-guided liver ... This study reviews our experience treating pts with high burden CRLM using MRI-guided stereotactic body radiation therapy (MRgRT).

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(21)06577-4/abstract

Ablative radiotherapy for liver tumors using stereotactic ... To prospectively determine the feasibility, safety, and efficacy of stereotactic body radiation therapy (SBRT) to primary and secondary liver ...

5. mdpi.com mdpi.com/2077-0383/12/10/3517

Local Therapies for Hepatocellular Carcinoma and Role of ... The emerging MRI-guided adaptive radiation therapy has been reviewed, highlighting its advantages and potential role in HCC management.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8036824/

Magnetic Resonance Imaging-Guided Adaptive ... MR-guided ablative radiation therapy is a promising radiation technology advance that can further facilitate safe tumor dose escalation of colorectal liver ...