Actively Recruiting
Ablative Dose Single Fraction MRI-Guided Stereotactic Body Radiation Therapy for Colorectal Liver Metastasis
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-18
32
Participants Needed
7
Research Sites
N/A
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
Researchers are evaluating a high-dose, single-session, MRI-guided stereotactic body radiation therapy (SBRT) for people with colorectal cancer that has spread to the liver. This study aims to see how well this treatment can stop liver metastases from growing or spreading and to track any side effects. They also want to identify features in MRI images that might predict how well patients respond to the therapy. Participants will first undergo a simulation scan using a special MRI contrast agent (Gd-EOB-DTPA) to help plan treatment with minimal margins. About ten days later, they will receive a single high dose of 40 Gy radiation delivered by the Elekta Unity machine, guided and adapted in real time by the enhanced MRI. This approach focuses radiation precisely on liver tumors while sparing healthy tissue. During the study, participants will have assessments including the initial MRI scan for planning, treatment delivery with image guidance, and follow-up to monitor tumor control and side effects. The main outcome measured is the local control rate of liver metastases one year after treatment. Researchers will also closely monitor liver function and any adverse effects. The total participation duration extends through at least one year of follow-up after treatment.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed colorectal cancer with liver metastasis shown on imaging
- ECOG performance status 0 to 2
- Up to 3 liver lesions measurable on contrast-enhanced MRI with combined size less than 7 cm and each lesion smaller than 5 cm
- Lesions located at least 2 cm from main, right, and left portal veins on baseline MRI
- Lesions located at least 1.5 cm from the stomach, small bowel, and large bowel
- Lesions located at least 0.5 cm from the diaphragm
- Preserved liver function with albumin above 2 g/dl, AST/ALT less than or equal to 5 times upper limit of normal, and total bilirubin less than or equal to 1.5 times upper limit
- Negative pregnancy test within 14 days prior to simulation for women of childbearing potential
- Prior systemic or hepatic artery intraarterial chemotherapy allowed with 2-week washout
- Prior biologic or targeted therapies allowed with 1-week or 4 half-lives washout
- Extrahepatic disease allowed
- Prior liver surgery allowed if enough liver remains
- Prior liver radiation allowed if normal tissue constraints can be met
- Review by hepatobiliary multidisciplinary team prior to enrollment
You will not qualify if you...
- Any history of cirrhosis
- History of hepatic radioembolization or selective internal radiation therapy
- History of inflammatory bowel disease preventing liver radiation
- Current pregnancy or breastfeeding
- Men or women not using effective contraception
- Contraindications to MRI including unsafe implants, pacemakers, defibrillators, claustrophobia, or contrast agent allergy
- Receiving anti-cancer therapy within 1 week of radiation treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo simulation including Gd-EOB-DTPA-enhanced MRI and planning using minimal margins to prepare for treatment.
1 visit (in-person)
Duration - 1 day
Participants receive a single 40Gy fraction of MR Guided Stereotactic Body Radiation Therapy using on-line adaptive replanning for liver metastasis.
1 treatment visit (in-person)
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
Research Team
M
Marsha Reyngold, MD, PhD
N
Neelam Tyagi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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