MRI-Guided SBRT for Colorectal Cancer Liver Metastasis

This study is testing if a single session of high-dose, MRI-guided Stereotactic Body Radiation Therapy (SBRT) is effective for colorectal cancer that has spread to the liver. SBRT is a type of radiation therapy that delivers a very focused, high dose of radiation to a tumor. Researchers will use a special MRI scan with a contrast agent called Gd-EOB-DTPA to guide the treatment. They want to see how well this treatment prevents the liver tumors from growing and spreading, if it causes side effects, and if MRI images can help predict how well someone will respond. You may be able to join if you are 18 or older, have confirmed colorectal cancer with liver metastasis, and meet certain criteria for your overall health and tumor size. The study aims to enroll 32 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 32 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure how well the treatment controls the liver metastasis at 1 year.

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NCT06130280

A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~32 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT)

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local control rate CRC liver metastasis
Measured over 1 year
Colorectal Cancer
Liver Metastases
7 sites across 2 states
New York4
New Jersey3
  • Marsha Reyngold, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

Age ≥18
Histologically confirmed colorectal carcinoma and evidence of liver metastasis on imaging
ECOG 0-2
\<=3 liver lesions measurable on contrast enhanced diagnostic MRI with combined size (sum of longest diameters) \< 7 cm, and individual size \< 5cm. (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in size exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning).
Lesion location at least ≥ 2 cm of main, right and left portal vein on the baseline diagnostic MRI. (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in the distance between the lesion edge and critical structure exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning ).
Lesion location at least ≥ 1.5 cm of luminal gastrointestinal tract (stomach, small and large bowel). (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in the distance between the lesion edge and critical structure exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning).
Lesion location ≥ 0.5 cm of diaphragm
Preserved liver function as defined by:
Albumin \> 2 g/dl
\< AST/ ALT ≤ 5 x ULN
Total Bilirubin ≤ 1.5 x UL
Negative serum pregnancy test within 14 days prior to simulation and MRgRT for women of childbearing potential
Any prior systemic or hepatic artery intraarterial pump (HAIP) chemotherapy is permitted with a washout of 2 weeks
Any prior treatment with FDA-approved or investigational biologics or novel molecularly targeted therapies, including oral or IV formulations, are permitted with a washout of 1 weeks or 4 half-lives, which ever is longer
Extrahepatic disease outside the liver is permitted
Prior liver resection is permitted provided there is enough liver parenchyma to meet normal tissue contraints
Prior liver-directed RT is permitted provided departmental normal tissue constraints for re-irradiation can be met
Review by HBP DMT prior to enrollment

Exclusion

Any history of cirrhosis
History of hepatic radioembolization or selective internal radiation therapy (SIRT)
History of inflammatory bowel disease that precludes liver RT (at the discretion of the treating radiation oncologist).
Current pregnancy or breastfeeding
Men or women not using effective contraception.
Contraindication to or inability to undergo an MR scan, including, but not limited to the history of MR unsafe implants, any implanted cardiac pacemakers or deffibrilators, history of claustrophobia, and contraindications to Gd-EOB-DTPA contrast agent.
Concurrent anti-neoplastic therapy of any kind defined as receipt within 1 week of RT administration
  • Local control rate CRC liver metastasis1 year

    by RECIST