Actively Recruiting

Phase 2
Age: 18Years +
All Genders
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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-18

32

Participants Needed

7

Research Sites

155 weeks

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

E

Elekta Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed colorectal cancer with liver metastases seen on imaging
  • ECOG performance status between 0 and 2
  • No more than 3 liver lesions measurable on contrast-enhanced MRI with combined size under 7 cm and each lesion under 5 cm
  • Lesions located at least 2 cm away from main, right, and left portal veins on baseline MRI
  • Lesions located at least 1.5 cm away from the stomach, small bowel, and large bowel
  • Lesions located at least 0.5 cm away from the diaphragm
  • Preserved liver function defined by albumin > 2 g/dl, AST/ALT ≤ 5 times upper limit of normal, and total bilirubin ≤ 1.5 times upper limit
  • Negative pregnancy test within 14 days before treatment for women who can become pregnant
  • Any prior systemic or hepatic artery intraarterial pump chemotherapy allowed with a 2-week washout
  • Any prior treatment with FDA-approved or investigational biologics or targeted therapies allowed with a 1-week or 4 half-lives washout, whichever is longer
  • Extrahepatic disease outside the liver allowed
  • Prior liver surgery allowed if enough liver remains to meet normal tissue constraints
  • Prior liver-directed radiation allowed if normal tissue constraints for re-irradiation can be met
  • Review by hepatobiliary multidisciplinary team before enrollment
Not Eligible

You will not qualify if you...

  • History of cirrhosis
  • History of hepatic radioembolization or selective internal radiation therapy (SIRT)
  • History of inflammatory bowel disease preventing liver radiation therapy
  • Current pregnancy or breastfeeding
  • Men or women not using effective contraception
  • Contraindications to MRI including unsafe implants, pacemakers, defibrillators, claustrophobia, or inability to receive Gd-EOB-DTPA contrast
  • Receiving anti-cancer therapy within 1 week before radiation therapy

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

M

Marsha Reyngold, MD, PhD

CONTACT

N

Neelam Tyagi, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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