Stereotactic Magnetic Resonance Guided Radiation Therapy

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the study

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

What is being tested

MR-guided Linac (radiation)

Sponsor: Dana-Farber Cancer Institute · Participants: 397 · Started: Oct 22, 2019

Contact the study team

Jonathan Leeman, MD · Phone: 617-732-6452

Official record on ClinicalTrials.gov — NCT04115254

Locations in the U.S.

Massachusetts

Brigham & Women's Hospital, Boston
Dana Farber Cancer Institute, Boston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.