New MRI aims to spot which breast cancers will spread
NCT ID NCT03694756
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a special MRI technique called TMEM-MRI that looks at the tumor environment to see how likely breast cancer is to spread. About 95 women with operable breast cancer will get this MRI before their standard biopsy or surgery. The goal is to see if this imaging method can reliably measure features linked to metastasis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a new imaging tool that helps doctors identify which breast cancers are more likely to spread, guiding treatment decisions.
- What could go wrong
- This is a small, early feasibility study, not a treatment trial. The new MRI method may not prove reliable or useful in practice.
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 95 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2018
- Expected to finish
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Dec 2026
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 * For pre-pilot phase (MRI sequence development): o Patients with a breast mass, with biopsy-proven histology of invasive breast carcinoma (any histologic type and ER,PR,HER2 status) * For pilot phase Cohort A: o Patients with a breast mass considered highly suspicious for invasive carcinoma by the radiologist (BIRADS 5). * For pilot phase Cohort B: * Patients with a breast mass found to be invasive ductal carcinoma on core biopsy. * No preoperative therapy for the current breast cancer has been started (endocrine therapy, chemotherapy, or radiation). Patients can receive preoperative treatment after TMEM-MRI is conducted, if clinically indicated. * For pilot phase Cohort C: * Patients with locally advanced breast cancer, anatomic stage II-III, who received neoadjuvant therapy as per standard of care. * Residual palpable mass \> 1 cm in largest diameter after neoadjuvant therapy. * Candidate for breast MRI before definitive surgery. * Tumor size/breast mass should be \> 1 cm in largest diameter (radiologically). * Multifocal disease is allowed, as long as patients meet all eligibility criteria. * Age ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Willingness to undergo a "research breast MRI". * Patient must be able to undergo MRI with gadolinium enhancement. * No history of untreatable claustrophobia. * No presence of non-MRI compatible metallic objects or metallic objects that, in the opinion of a radiologist, would make MRI a contraindication. * No history of sickle cell disease. * No contraindication to intravenous contrast administration. * No known allergy-like reaction to gadolinium * No known or suspected renal impairment. Glomerular Filtration Rate (GFR) should be greater than 30 mL/min/1.73 m2. * Weight less than or equal to the MRI table limit. * Ability to understand and willingness to sign a written informed consent. Exclusion Criteria * Patients may not have had breast cancer or radiation therapy to the ipsilateral breast in the past. * No breast prosthetic implants (silicone or saline) are allowed. * Use of any investigational agent within 30 days of starting study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study. * Patients must be non-pregnant and non-lactating. Patients must have a negative pregnancy test (urine or serum) within 7 days of registration date.
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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
1 site. 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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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10461, United States
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