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Radiation

MRI-Guided SBRT for Colorectal Cancer with Liver Metastases

Phase 2
Recruiting
Led By Marsha Reyngold, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed colorectal carcinoma and evidence of liver metastasis on imaging
Lesion location at least ≥ 2 cm of main, right and left portal vein on the baseline diagnostic MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test if one session of high-dose radiation can stop colorectal cancer from spreading to the liver. Researchers will also assess any side effects & predictors of response.

Who is the study for?
This trial is for adults over 18 with colorectal cancer that has spread to the liver. They must have good liver function, not be pregnant or breastfeeding, and agree to use contraception. People can't join if they have cirrhosis, certain prior treatments like radioembolization, are unable to undergo MRI scans due to implants or claustrophobia, or are on other cancer therapies within a week of starting this study.Check my eligibility
What is being tested?
The trial tests whether one session of high-dose MRI-guided SBRT (a type of targeted radiation therapy) can effectively treat liver metastases from colorectal cancer without causing significant growth or spread. The effectiveness and side effects will be monitored along with any predictive factors in MRI images.See study design
What are the potential side effects?
Potential side effects may include damage to surrounding healthy liver tissue, fatigue, skin reactions at the treatment site, nausea and vomiting related to radiation exposure. There might also be risks associated with contrast agents used during MRI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My colorectal cancer has spread to my liver.
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My lesion is at least 2 cm away from the main blood vessels in my liver.
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My lesion is located in my stomach or intestines, at least 1.5 cm inside.
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My liver is functioning well, and I am not pregnant.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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I have up to 3 liver lesions, all under 7 cm combined and each under 5 cm.
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My lesion is located at least 0.5 cm away from my diaphragm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local control rate CRC liver metastasis

Trial Design

1Treatment groups
Experimental Treatment
Group I: MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT)Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,866 Total Patients Enrolled
Elekta LimitedIndustry Sponsor
9 Previous Clinical Trials
8,796 Total Patients Enrolled
Marsha Reyngold, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any North American hospitals administering this research project?

"There are a total of 7 locations involved with this trial, including Memorial Sloan Kettering Cancer Center in New york which offers all protocol activities, as well as MSK Basking Ridge and MSK Bergen's limited protocol services."

Answered by AI

What is the total capacity of participants in this research?

"Affirmative, clinicaltrials.gov has published information indicating that this medical research is actively seeking participants. Initially posted on November 8th 2023 and last updated the same day, 32 patients are being recruited from 7 distinct sites."

Answered by AI

Is enrollment currently open for this clinical trial?

"According to clinicaltrials.gov, this research project is searching for qualified participants and has been active since November 8th 2023 (last updated on the same date)."

Answered by AI

What potential risks does MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT) pose to individuals?

"MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT) has been assigned a value of 2 due to the Phase 2 trial, which offers data that corroborates its safety but not its efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer
2023. "A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06130280.
~21 spots leftby Nov 2026
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