MRI-Guided SBRT for Liver Metastases
This study is testing a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) for people with liver metastases (cancer that has spread to the liver). The SBRT treatment will be guided by MRI (magnetic resonance imaging) in real time. The main goal is to find the highest safe dose of SBRT that can be given using this MRI guidance. You may be able to join if you are 18 or older, have liver metastases, and are a candidate for SBRT treatment on the ViewRay machine. The study will look at how many participants experience serious side effects within four weeks of treatment. This study is currently unclear about its recruitment status and plans to enroll 32 participants.
- Study design
- This is an interventional study with a planned enrollment of 32 participants. It is designed to find the safest maximum dose of SBRT.
- What's involved
- You would receive 5 radiation treatments (SBRT) over 1.5 to 2 weeks, delivered 2-3 times per week. You would be on the study for up to 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures side effects up to 4 weeks after treatment. Participants will be on study for up to 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04020276
OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases
Recruiting
NAAges 18+InterventionalTreatmentUniversity of Wisconsin, MadisonInvestigator-initiated
~32 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:SBRT
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Acute Dose Limiting Toxicity (DLT)
Measured over Up to 4 weeks
Conditions
NCT04020276
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Wisconsin
Madison, Wisconsinstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Michael Bassetti, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
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Eligibility criteria
Inclusion
Have a diagnosis of histologically confirmed or clinically suspected metastatic cancer to the liver.
Participant must be a candidate for SBRT to at least one intrahepatic lesion but no more than 6 intrahepatic lesions.
Participant must be a candidate for treatment on the ViewRay treatment unit. Must be screened to rule out implants and devices that are not MRI compatible.
Be willing and able to provide written informed consent.
Participants may be therapy-naïve or have had prior systemic therapy up to two weeks prior to study entry.
No active central nervous system (CNS) metastatic disease. NOTE: Subjects with CNS involvement must meet all of the following to be eligible:
At least 28 days from prior definitive treatment of their CNS disease by surgical resection, SBRT or Whole Brain Radiation Therapy (WBRT) at the time of registration
AND asymptomatic and off systemic corticosteroids and/or enzyme-inducing antiepileptic medications for brain metastases for \>14 days prior to registration.
Demonstrate adequate organ function as defined in the following table; all screening labs should be performed within 28 days of SBRT treatment initiation.
Platelet count greater than or equal to 50000 /µL
Absolute Neutrophil Count (ANC) greater than or equal to 1000 /µL
Hemoglobin (Hgb) greater than or equal to 8 g/dL or greater than or equal to 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) Creatinine/Calculated creatinine clearance (CrCl) greater than or equal to 30 mL/min for subject with creatinine levels greater than 1.5 X institutional upper limit of normal (ULN)
Bilirubin greater than or equal to 1. 5 × ULN OR direct bilirubin greater than or equal to ULN for participants with total bilirubin levels greater than 1.5 ULN
Aspartate aminotransferase (AST) and ALT (SGPT) greater than or equal to 5 × ULN
International Normalized Ratio (INR) or Prothrombin Time (PT) greater than or equal to 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Activated Partial Thromboplastin Time (aPTT) greater than or equal to 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
For participants enrolled on the liver dose escalation arm, screening labs must be consistent with Child Pugh class A unless therapeutic anticoagulation places them in Child Pugh B. In that case, trial entry or exclusion will be at the discretion of the treating physician.
Have a performance status of 2 or less on the Eastern Cooperative Oncology Group (ECOG) performance scale.
Life expectancy of \> 12 weeks.
Women of childbearing potential (WOCP) should have a negative urine or serum pregnancy test prior to initiation of radiation therapy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
WOCP must not be pregnant or breast-feeding.
WOCP must be willing to use an effective method of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the duration of the radiotherapy and 60 days thereafter.
Is post-menarcheal (i.e., has had at least one prior menses)
Has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the initiation of SBRT.
History of a second invasive cancer in the last 3 years (except for appropriately treated low-risk prostate cancer, treated non-melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast appropriately treated in situ/early stage cervical/endometrial cancer.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with follow up scans or visits.
Has a primary tumor histology of germ cell tumor, leukemia, or lymphoma.
Has a primary liver cancer such as cholangiocarcinoma or hepatocellular carcinoma.
Has had prior radiation therapy that significantly overlaps with the liver.
Has a diagnosis of Crohn's disease, ulcerative colitis, or scleroderma.
Participants with Gilbert's disease or other primary disorders of bilirubin metabolism will not be allowed on the trial.
For participants in the liver dose escalation arm only, has pre-existing liver disease such that patients are classified as Child Pugh B or worse. If the participant is anti-coagulated such that their INR places them in the CP-B classification, exclusion or inclusion will be at the discretion of the treating physician.
Pregnancy or women of childbearing potential and men who are sexually active and refuse to use medically acceptable forms of contraception.
Participants with implanted hardware that would preclude MRIs.
What this trial measures
- Number of Participants with Acute Dose Limiting Toxicity (DLT)Up to 4 weeks
Dose limiting toxicity (DLT) will be defined as grade 3 or greater\* non-hematologic toxicity attributable to radiation therapy, and occurring within 4 weeks after the completion of SBRT. \*With the exception of liver function tests, which are allowed up to and including grade 3