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New MRI aims to spot which breast cancers will spread

NCT ID NCT03694756

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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 95 people

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

Started

Dec 2018

Expected to finish

Dec 2026

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 * 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.

  1. The places running it

    1 site. 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

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

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