Brain scans could spot hidden cancer spread in breast patients
NCT ID NCT04030507
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This study is testing whether regular MRI scans of the brain can find cancer that has spread from the breast to the brain, even before symptoms appear. It involves 214 people with metastatic or inflammatory breast cancer. The goal is to see if early detection through screening improves quality of life and outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MRI (magnetic resonance imaging) scan
- What this could lead to
- If successful, this could show that routine brain MRI helps catch cancer spread early, potentially leading to better treatment timing and quality of life.
- What could go wrong
- This is an early-stage observational study, not a treatment trial. It may not prove that MRI screening improves survival or prevents symptoms, and false positives could cause unnecessary anxiety or procedures.
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 214 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2019
- Expected to finish
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Feb 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.
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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 histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and/or study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment. * Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic/recurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis. * Participants must be age 18 years or older. * Participants must have a life expectancy of greater than 12 weeks. * Participants must be willing to undergo study procedures. * The effects of gadolinium / other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential 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. Exclusion Criteria: * Participants who have a contraindication to MRI (e.g. noncompatible 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. * Patients with a prior diagnosis of brain metastases
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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.
Contacts and locations
Locations
-
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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