Actively Recruiting
OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases
Led by University of Wisconsin, Madison · Updated on 2026-01-13
32
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this trial is to identify a safe maximum tolerated dose level for MRI-guided Stereotactic Body Radiation Therapy (SBRT) treatment of bowel and liver metastases, respectively. Eligible participants will be on study for up to 12 months.
CONDITIONS
Official Title
OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically confirmed or clinically suspected metastatic cancer to the liver.
- Candidate for SBRT to at least one and no more than six intrahepatic lesions.
- Eligible for treatment on the MRI-compatible ViewRay treatment unit with no incompatible implants or devices.
- Willing and able to provide written informed consent.
- May be therapy-nafve or have had prior systemic therapy up to two weeks before study entry.
- No active central nervous system metastatic disease, or must meet specified criteria if CNS disease is present.
- Adequate organ function based on blood counts, liver and kidney function tests within 28 days before treatment.
- For liver dose escalation arm, consistent with Child Pugh class A unless anticoagulated, then inclusion or exclusion at physician's discretion.
- Performance status of 2 or less on the Eastern Cooperative Oncology Group scale.
- Life expectancy greater than 12 weeks.
- Women of childbearing potential must have a negative pregnancy test and use effective birth control during therapy and 60 days after.
- Willing and able to comply with study treatment, visits, and examinations.
You will not qualify if you...
- Currently participating in another investigational study or received investigational therapy/device within 4 weeks before SBRT.
- History of a second invasive cancer in the last 3 years, except certain treated low-risk cancers.
- Active infection requiring systemic therapy.
- Conditions, therapies, or laboratory abnormalities that could interfere with participation or trial results.
- Known psychiatric or substance abuse disorders affecting follow-up.
- Primary tumor types of germ cell tumor, leukemia, lymphoma, or primary liver cancers like cholangiocarcinoma or hepatocellular carcinoma.
- Prior radiation therapy overlapping significantly with the liver.
- Diagnosis of Crohn's disease, ulcerative colitis, or scleroderma.
- Disorders of bilirubin metabolism such as Gilbert's disease.
- For liver dose escalation arm, pre-existing liver disease classified as Child Pugh B or worse unless anticoagulated and approved by physician.
- Pregnancy or unwillingness to use medically acceptable contraception.
- Implanted hardware incompatible with MRI.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here