MRI-Guided SBRT for Colorectal Cancer with Liver Metastases

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Marsha Reyngold, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antineoplastics

Disqualifiers: Cirrhosis, Hepatic radioembolization, Pregnancy, others

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of 2 weeks for prior chemotherapy and 1 week or 4 half-lives for biologics or targeted therapies, whichever is longer. You may need to stop some medications before participating.

What data supports the effectiveness of the treatment MRI-Guided SBRT for Colorectal Cancer with Liver Metastases?

Research shows that MRI-guided stereotactic body radiation therapy (SBRT) is effective in controlling liver metastases, with high local control rates and improved precision due to better imaging. This suggests that MRI-guided SBRT could be a promising treatment for colorectal cancer with liver metastases.

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Is MRI-guided SBRT safe for treating liver metastases?

MRI-guided SBRT for liver metastases has been shown to be generally safe, with most patients experiencing only mild side effects like nausea. No severe side effects were reported in the studies.

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How is MRI-Guided SBRT different from other treatments for colorectal cancer with liver metastases?

MRI-Guided SBRT is unique because it uses magnetic resonance imaging (MRI) to precisely target liver metastases without the need for markers, offering high soft tissue contrast and potentially higher radiation doses while sparing surrounding healthy organs.

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Eligibility Criteria

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.

Inclusion Criteria

My colorectal cancer has spread to my liver.

My lesion is at least 2 cm away from the main blood vessels in my liver.

My lesion is located in my stomach or intestines, at least 1.5 cm inside.

Exclusion Criteria

I have a history of cirrhosis.

I have had liver-targeted radiation therapy.

I am not using any form of birth control.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulation and Planning

Participants undergo simulation including Gd-EOB-DTPA-enhanced MR and planning using minimal margins

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single fraction of 40Gy SBRT guided by MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Participant Groups

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.

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

MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT) is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

🇪🇺 Approved in European Union as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

🇨🇦 Approved in Canada as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

🇯🇵 Approved in Japan as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

🇨🇳 Approved in China as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

🇨🇭 Approved in Switzerland as Stereotactic Body Radiation Therapy for:

• Liver metastases from colorectal cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale, NJ

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge, NJ

Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison, NY

Memorial Sloan Kettering Cancer Center (All protocol activities) New York, NY

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

Elekta Limited Industry Sponsor

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Local control and patient reported outcomes after online MR guided stereotactic body radiotherapy of liver metastases. [2023] Stereotactic body radiotherapy (SBRT) is used to treat liver metastases with the intention of ablation. High local control rates were shown. Magnetic resonance imaging guided radiotherapy (MRgRT) provides the opportunity of a marker-less liver SBRT treatment due to the high soft tissue contrast. We report herein on one of the largest cohorts of patients treated with online MRgRT of liver metastases focusing on oncological outcome, toxicity, patient reported outcome measures (PROMs), quality of life.

2. United States pubmed.ncbi.nlm.nih.gov

Simulated Online Adaptive Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Oligometastatic Disease of the Abdomen and Central Thorax: Characterization of Potential Advantages. [2022] To characterize potential advantages of online-adaptive magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) to treat oligometastatic disease of the non-liver abdomen and central thorax.

3. Ireland pubmed.ncbi.nlm.nih.gov

Ablative radiotherapy for liver tumors using stereotactic MRI-guidance: A prospective phase I trial. [2022] To prospectively determine the feasibility, safety, and efficacy of stereotactic body radiation therapy (SBRT) to primary and secondary liver tumors with MR-guided radiation therapy (MRgRT).

4. England pubmed.ncbi.nlm.nih.gov

Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. [2022] Introduction of online adaptive MR-guided radiotherapy enables stereotactic body radiation therapy (SBRT) of upper abdominal tumors. This study aimed to evaluate the feasibility of MR-guided SBRT on a 1.5 T MR-linac in patients with unresectable upper abdominal malignancies.

5. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric feasibility of hypofractionation for SBRT treatment of lymph node oligometastases on the 1.5T MR-linac. [2021] At our department, MR-guided stereotactic body radiation therapy (SBRT) using the 1.5T MR-linac system (Unity, Elekta AB, Stockholm, Sweden) has been initiated for patients with lymph node oligometastases. Superior soft tissue contrast and the possibility for online plan adaptation on the Unity may allow for hypofractionated treatment. The purpose of this study was to investigate the dosimetric feasibility and compare the plan quality of different hypofractionated schemes.

6. Ireland pubmed.ncbi.nlm.nih.gov

Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance. [2022] Stereotactic body radiotherapy (SBRT) is an established ablative treatment for liver tumors with excellent local control rates. Magnetic resonance imaging guided radiotherapy (MRgRT) provides superior soft tissue contrast and may therefore facilitate a marker-less liver SBRT workflow. The goal of the present study was to investigate feasibility, workflow parameters, toxicity and patient acceptance of MRgSBRT on a 1.5 T MR-Linac.

7. Ireland pubmed.ncbi.nlm.nih.gov

A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. [2023] Stereotactic body radiation therapy (SBRT) has demonstrated safe and effective results for primary liver tumors. Magnetic Resonance guided Radiotherapy (MRgRT) is an innovative radiotherapy modality for abdominal tumors. The aim of this study is to report on acute and late toxicities and initial oncological results for primary liver tumors treated with MRgRT.

8. United States pubmed.ncbi.nlm.nih.gov

A Multi-Institutional Experience of MR-Guided Liver Stereotactic Body Radiation Therapy. [2022] Daily magnetic resonance (MR)-guided radiation has the potential to improve stereotactic body radiation therapy (SBRT) for tumors of the liver. Magnetic resonance imaging (MRI) introduces unique variables that are untested clinically: electron return effect, MRI geometric distortion, MRI to radiation therapy isocenter uncertainty, multileaf collimator position error, and uncertainties with voxel size and tracking. All could lead to increased toxicity and/or local recurrences with SBRT. In this multi-institutional study, we hypothesized that direct visualization provided by MR guidance could allow the use of small treatment volumes to spare normal tissues while maintaining clinical outcomes despite the aforementioned uncertainties in MR-guided treatment.

9. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Results of MR-Guided Stereotactic Body Radiotherapy of Liver Metastases. [2023] (1) Background: Magnetic-resonance (MR)-guided stereotactic body radiotherapy (SBRT) allows for ablative, non-invasive treatment of liver metastases. However, long-term clinical outcome data are missing. (2) Methods: Patients received MR-guided SBRT with a MRIdian Linac between January 2019 and October 2021 and were part of an ongoing prospective observational registry. Local hepatic control (LHC), distant hepatic control (DHC), progression free survival (PFS) and overall survival (OS) were estimated with the Kaplan-Meier method. Toxicity was documented according to CTCAE (v.5.0). (3) Results: Forty patients were treated for a total of 54 liver metastases (56% with online plan adaptation). Median prescribed dose was 50 Gy in five fractions equal to a biologically effective dose (BED) (alpha/beta = 10 Gy) of 100 Gy. At 1 and 2 years, LHC was 98% and 75%, DHC was 34% and 15%, PFS was 21% and 5% and OS was 83% and 57%. Two-year LHC was higher in case of BED > 100 Gy (100% vs. 57%; log-rank p = 0.04). Acute grade 1 and 2 toxicity (mostly nausea) occurred in 26% and 7% of the patients, with no grade ≥ 3 event. (4) Conclusions: To our knowledge, this is the largest cohort of MR-guided liver SBRT. Long-term local control was promising and underscores the aim of achieving >100 Gy BED. Nonetheless, distant tumor control remains challenging.

10. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Stereotactic Body Radiotherapy of Liver Tumors: Initial Clinical Experience and Patient-Reported Outcomes. [2022] Stereotactic body radiation therapy (SBRT) has emerged as a valid treatment alternative for non-resectable liver metastases or hepatocellular carcinomas (HCC). Magnetic resonance (MR) guided SBRT has a high potential of further improving treatment quality, allowing for higher, tumoricidal irradiation doses whilst simultaneously sparing organs at risk. However, data on treatment outcome and patient acceptance is still limited.

11. Ireland pubmed.ncbi.nlm.nih.gov

Technical feasibility and clinical evaluation of 4D-MRI guided liver SBRT on the MR-linac. [2022] Image-guided stereotactic body radiation therapy (SBRT) is an important local treatment for liver metastases. MRI-guidance enables direct tumor visualization, eliminating fiducial marker implantation. The purpose of this study was to test technical feasibility of our 4D-MRI guided liver SBRT workflow. Additionally, intra-fraction target motion and consequent target-coverage were studied.