Recruiting
Phase 2

SBRT

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06130280

Conditions

Colorectal Cancer

Liver Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT)

Study Details

Brief summary:

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

Colorectal Cancer

Liver Metastases

Study ID

NCT06130280

Start date

Nov 8, 2023

Status verified date

Feb, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Local control rate CRC liver metastasis [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Marsha Reyngold, MD, PhD

516-559-1527reyngolm@mskcc.org

Neelam Tyagi, PhD

646-608-2479

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Marsha Reyngold, MD, PhD

631-623-4267

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Marsha Reyngold, MD, PhD

631-623-4267

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Marsha Reyngold, MD, PhD

631-623-4267

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Marsha Reyngold, MD, PhD

631-623-4267

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Marsha Reyngold, MD, PhD

631-623-4267

Memorial Sloan Kettering Cancer Center (All protocol activities)

Recruiting

New York, New York, United States, 10065

Contacts

Marsha Reyngold, MD, PhD

631-623-4267

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Marsha Reyngold, MD, PhD

631-623-4267

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • Single Fraction Stereotactic Body Radiation Therapy (SBRT)
  • Magnetic Resonance Imaging (MRI)
  • 23-285

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-02-18.