MRI-Guided radiation aims to safely boost liver tumor treatment
NCT ID NCT04020276
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether MRI-guided radiation therapy (SBRT) can be given at higher doses safely to people with cancer that has spread to the liver. Up to 32 participants will receive 5 radiation sessions over 1.5 to 2 weeks. The main goal is to find the highest dose that does not cause serious side effects within the first month.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic Body Radiation Therapy (SBRT) with real-time MRI guidance
- What this could lead to
- If successful, this could establish a safer, more effective radiation dose for treating liver metastases, potentially improving tumor control with fewer side effects.
- What could go wrong
- This is an early phase I trial with only 32 participants, focused on safety and dosing. It may not lead to better outcomes, and there is a risk of radiation-related toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2019
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. NOTE: A person of childbearing potential is anyone (regardless of sexual orientation, gender identity, having undergone a tubal ligation, or remaining celibate by choice) who was born with a uterus and at least one ovary and meets both of the following criteria: * 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 Criteria: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Liver metastases are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
University of Wisconsin
RECRUITINGMadison, Wisconsin, 53792, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?
- Can a Pressure-Sensitive catheter sharpen Radiation's aim at liver tumors?
- Can removing liver tumors alongside the whipple procedure extend life in stage IV pancreatic cancer?
- Mapping tumors in 3D: could imaging reveal hidden growth patterns?
- A new test could reveal how radiation affects the liver
- A new clue in the fight against colorectal cancer recurrence?