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Stereotactic MR-Guided Radiation Therapy for Various Cancers

This study is testing a new way to deliver radiation therapy called Stereotactic Magnetic Resonance Guided Radiation Therapy (SMART) using an MR-guided Linear Accelerator. This is a first-time evaluation at this institution to see if adjusting radiation treatments daily based on MRI is a practical way to treat pancreatic, lung, or kidney cancer. The study is open to adults aged 18 and older with certain cancers (pancreas, lung, kidney, adrenal metastases, prostate) that require stereotactic body radiation therapy, and whose tumor is 7cm or smaller. The main goals are to see how successfully the radiation can be delivered, how well the tumor can be seen, and how easily treatment plans can be created, all measured at 1 year.

Study design
This is a Phase I-II interventional study, meaning it's testing a new treatment. It aims to enroll 397 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 1 year after treatment.

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NCT04115254

Stereotactic Magnetic Resonance Guided Radiation Therapy

Recruiting
NAAges 18+InterventionalTreatment
Dana-Farber Cancer Institute
~397 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:MR-guided Linac

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Delivery Success Rate for SMART across multiple tumors-Phase I
Measured over 1 year
+3 more outcomes measured

Conditions

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

Explore related trials

Kidney CarcinomaLung CarcinomaMesothelial NeoplasmPancreatic CarcinomaProstate CarcinomaSolid Neoplasm

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Jonathan Leeman, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Jonathan Leeman, MD
[email protected]
617-732-6452
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Eligibility criteria

Inclusion

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

Specific exclusion requirements for each disease site with be covered in each specific cohort
History of allergic reactions attributed to gadolinium-based IV contrast.
Pregnant women are excluded from this study.
Severe claustrophobia or anxiety
Participants who cannot undergo an MRI

What this trial measures

  • Delivery Success Rate for SMART across multiple tumors-Phase I1 year

    Enrolling patients and delivering SMART on the MR Linac

  • Tumor visualization-Phase I1 Year

    Assessing tumor using MR guidance before, during and after MR-guided treatment patient

  • Plan creation-Phase I1 Year

    Generating adaptive plans

  • Rate of Improvement in Tumor Control-Phase II1 Year

    Statistical power will be defined in each cohort individually and will be specific to each disease site tested.