Stereotactic Magnetic Resonance Guided Radiation Therapy

November 11, 2025 updated by: Jonathan Leeman, MD, Dana-Farber Cancer Institute

A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.

  • The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.
  • Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation to treat cancer.

The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.

In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
397

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
          • Jonathan Leeman, MD
        • Principal Investigator:
          • Jonathan Leeman, MD
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham & Women's Hospital
        • Contact:
          • Jonathan Leeman, MD
        • Principal Investigator:
          • Jonathan Leeman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.
  • Tumor size ≤ 7cm
  • Age 18 years of older.
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • Ability to understand and the willingness to sign a written informed consent document.
  • Specific eligibility requirements for each disease site with be covered in each specific cohort.

Exclusion Criteria:

  • Specific exclusion requirements for each disease site with be covered in each specific cohort

  • History of allergic reactions attributed to gadolinium-based IV contrast.

    -- Note: If a patient will not receive contrast, this is not applicable

  • Pregnant women are excluded from this study.
  • Severe claustrophobia or anxiety
  • Participants who cannot undergo an MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator
Experimental: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes
SMART will be administered per each individual disease site standards
Radiation: MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Delivery Success Rate for SMART across multiple tumors-Phase I
Time Frame: 1 year
Enrolling patients and delivering SMART on the MR Linac
1 year
Tumor visualization-Phase I
Time Frame: 1 Year
Assessing tumor using MR guidance before, during and after MR-guided treatment patient
1 Year
Plan creation-Phase I
Time Frame: 1 Year
Generating adaptive plans
1 Year
Rate of Improvement in Tumor Control-Phase II
Time Frame: 1 Year
Statistical power will be defined in each cohort individually and will be specific to each disease site tested.
1 Year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Patients with Acute Toxicity-Phase I
Time Frame: 90 Days
Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART
90 Days
Duration of treatment-Phase 1
Time Frame: 90 Days
Duration of treatment with goal of >80% of cases treated within 90 minutes
90 Days
Number of treatment fractions-Phase1
Time Frame: 90 Days
Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART
90 Days
Number of Participants with long term toxicity-Phase II
Time Frame: 365 Days
assessing long-term (12 month) toxicity in patients receiving SMART
365 Days
Disease Specific Survival Rate-Phase II
Time Frame: 365 Days
Kaplan-Meier curve estimates
365 Days
Overall Survival Rate-Phase II
Time Frame: 365
Kaplan-Meier curve estimates
365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dana-Farber Cancer Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Leeman, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Dr. Jonathan Leeman (jonathane_leeman@dfci.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

BWH - Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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