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MRI-Guided radiation aims to hit tumors harder, spare healthy tissue

NCT ID NCT04115254

Disease control Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This master trial is testing a new radiation technique called SMART, which uses MRI to guide and adapt radiation beams in real time. The goal is to deliver high doses precisely to tumors while protecting nearby organs. The study enrolls adults with various cancers (pancreas, lung, kidney, prostate, liver, and others) and has two phases: Phase I checks if the treatment is safe and feasible, and Phase II looks at how well it controls tumors and improves patient quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MR-guided radiation therapy (SMART)
What this could lead to
If successful, this could show that SMART is a safe and effective way to deliver high-precision radiation to many types of tumors, potentially improving tumor control and reducing side effects.
What could go wrong
This is an early-phase trial (Phase I/II) with no control group, so results may not prove superiority over standard radiation. Side effects from high-dose radiation are possible, and success in one tumor type may not apply to others.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 397 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

brain cancer kidney cancer lung cancer lung neoplasm malignant pancreatic neoplasm mesothelioma metastatic carcinoma in the bone pancreatic neoplasm prostate cancer renal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adrenal metastases Borderline resectable pancreatic carcinoma Brain metastases Liver metastases Lung cancer Mesothelioma Metachronous nodal metastases Oligoprogressive nodal metastases Pancreas cancer Prostate cancer Renal cancer Spine metastases Synchronous nodal metastases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham & Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

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