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

  • End date
    Jun 18, 2024
  • participants needed
  • sponsor
    Dana-Farber Cancer Institute
Updated on 18 October 2022
stereotactic body radiation therapy
primary cancer


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


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.

Condition Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases, Prostate Cancer, Liver Metastases, Oligoprogressive Nodal Metastases, Metachronous Nodal Metastases, Synchronous Nodal Metastases, Mesothelioma, Spine Metastases, Brain Metastases, Borderline Resectable Pancreatic Carcinoma
Treatment MR-guided Linac
Clinical Study IdentifierNCT04115254
SponsorDana-Farber Cancer Institute
Last Modified on18 October 2022


Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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