A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer
NCT ID: NCT06130280
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
32 participants
INTERVENTIONAL
2023-11-08
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Elekta Limited
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Marsha Reyngold, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Neelam Tyagi, PhD
Role: CONTACT
Facility Contacts
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Marsha Reyngold, MD, PhD
Role: primary
Marsha Reyngold, MD, PhD
Role: primary
Marsha Reyngold, MD, PhD
Role: primary
Marsha Reyngold, MD, PhD
Role: primary
Marsha Reyngold, MD, PhD
Role: primary
Marsha Reyngold, MD, PhD
Role: primary
Marsha Reyngold, MD, PhD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-285
Identifier Type: -
Identifier Source: org_study_id