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Stereotactic Magnetic Resonance Guided Radiation Therapy | Clinical Trials | Clareo Health

RECRUITINGNA

Stereotactic Magnetic Resonance Guided Radiation Therapy

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

NCT04115254•Dana-Farber Cancer Institute

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Brigham & Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

October 22, 2019

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

November 13, 2025

Enrollment

397

ESTIMATED participants

Conditions

Pancreas CancerLung CancerRenal CancerAdrenal MetastasesProstate CancerLiver MetastasesOligoprogressive Nodal MetastasesMetachronous Nodal MetastasesSynchronous Nodal MetastasesMesotheliomaSpine MetastasesBrain MetastasesBorderline Resectable Pancreatic Carcinoma

Interventions

MR-guided Linac

RADIATION

Contacts

Jonathan Leeman, MD

CONTACT

617-732-6452 JONATHANE_LEEMAN@DFCI.HARVARD.EDU

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Stereotactic Magnetic Resonance Guided Radiation Therapy

Inclusion Criteria

Exclusion Criteria

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