New MRI method may end guesswork for brain tumor patients after radiation
NCT ID NCT04033497
First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This study tests a special MRI technique to help doctors tell whether an enlarged spot in the brain after radiation is the tumor growing back or harmless scar tissue from the radiation. About 100 adults with brain metastases who had radiation will get this MRI before any surgery. The results will be checked against the actual tissue to see how accurate the MRI is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MRI scan
- What this could lead to
- If successful, this MRI method could help doctors accurately tell tumor regrowth from radiation scarring without needing a biopsy.
- What could go wrong
- This is a small, early study (101 people) testing a new imaging technique. It may not prove accurate enough to replace standard diagnosis, and results may not apply to all patients.
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
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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
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About 101 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2019
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 histologically or cytologically confirmed solid malignancy of extracranial origin and radiographic evidence of at least one brain metastasis for which stereotactic radiation was utilized in the past. Patients with intracranial pathologic confirmation of a malignancy which originated extracranially but for which extracranial disease has not been biopsied are eligible. * Participants must have an enlarging lesion in the brain at least 4 months after prior stereotactic radiation to the same site for which neurosurgical resection is planned as routine standard of care. * Participants must be age 18 years or older. * Participants must be willing to undergo study procedures. * The effects of gadolinium / other MRI-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. * Participants must possess the ability to understand and the willingness to sign a written informed consent document via ink on paper or via an electronic signature medium such as Adobe Sign. Exclusion Criteria: * Participants who have a contraindication to MRI (e.g. non compatible implanted metallic device for which MRI is absolutely contraindicated). * Participants who have chronic kidney disease stage IV-V or end stage renal disease. * Participants with a history of anaphylactic reactions to gadolinium. * Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can doctors watch brain metastases instead of zapping them?
- Starving brain tumors of blood before surgery
- Tiny gadolinium particles aim to make brain radiation hit harder
- Zapping the brain to restore lost vision
- Brain surgery delirium: can real-time monitoring protect older patients?
- A sharper MRI could reveal radiation sensitivity of brain tumors