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

Ablative Dose Single Fraction MRguided Colorectal Liver Metastasis SBRT

The researchers are doing this study to see if one session of high-dose contrast-enhanced MRI-guided SBRT (stereotactic body radiation therapy) is effective for colorectal cancer that has spread to the liver. The researchers will evaluate how well the study treatment can prevent the liver metastasis from growing and spreading. In addition, they will see whether it causes any side effects and whether there are any characteristics of the research MRI images that can predict response to treatment.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Radiation: MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT)

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marsha Reyngold, MD, PhD; Phone Number: 516-559-1527; Email: reyngolm@mskcc.org
• Study Contact Backup: Name: Neelam Tyagi, PhD; Phone Number: 646-608-2479

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Marsha Reyngold, MD, PhD; Phone Number: 631-623-4267
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Marsha Reyngold, MD, PhD; Phone Number: 631-623-4267
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Marsha Reyngold, MD, PhD; Phone Number: 631-623-4267
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
      • Contact: Marsha Reyngold, MD, PhD; Phone Number: 631-623-4267
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited protocol activities)
      • Contact: Marsha Reyngold, MD, PhD; Phone Number: 631-623-4267
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All protocol activities)
      • Contact: Marsha Reyngold, MD, PhD; Phone Number: 631-623-4267
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
      • Contact: Marsha Reyngold, MD, PhD; Phone Number: 631-623-4267

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT); Participants will undergo simulation including Gd-EOB-DTPAenhanced MR and planning using minimal margins. Ten days later (+/- 3 days) participants will receive 40Gy single fraction treatment on Elekta Unity using Gd-EOB-DTPA-enhanced MR for image guidance and on-line adaptive replanning.	Radiation: MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT); 40Gy single fraction treatment on Elekta Unity using Gd-EOB-DTPA-enhanced MR for image guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control rate CRC liver metastasis	by RECIST	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Elekta Limited
• Investigators: Principal Investigator: Marsha Reyngold, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging (MRI); Single Fraction Stereotactic Body Radiation Therapy (SBRT); 23-285
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 23-285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No