OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases (NCT04020276)
A Phase I Study of OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (14 items).
Location: University of Wisconsin — Madison, Wisconsin
Age range: 18 Years
🧪 Interventions in This Study
- SBRT (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Wisconsin — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (800) 622-8922
Email: clinicaltrials@cancer.wisc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.