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TMEM-MRI for Operable Breast Cancer

This study is looking at a new imaging method called TMEM-MRI (Tumor Microenvironment of Metastasis - Magnetic Resonance imaging) for people with breast cancer that can be operated on. The goal is to see if TMEM-MRI can help doctors understand how likely cancer cells are to spread by detecting "leakiness" in the tumor, where cancer cells might enter blood vessels. This could help predict if the cancer might come back and how well treatments like chemotherapy are working. You might be able to join if you are 18 or older, have a breast mass that looks highly suspicious for cancer, or have a confirmed diagnosis of invasive breast cancer. The study aims to enroll about 95 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention (TMEM-MRI). It plans to enroll 95 participants.
What's involved
You would have a TMEM-MRI scan, which involves lying in an MRI machine and receiving a contrast agent through an IV. Some participants will also have an FNA (fine needle aspiration) during an ultrasound-guided biopsy.
Compensation
Not stated in the trial record.
Follow-up
Tumor permeability will be assessed at different times, including around 14 days after breast biopsy or after neoadjuvant therapy and up to 56 days before surgery.

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NCT03694756

TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer

Recruiting
NAAges 18+Interventional
Montefiore Medical Center
~95 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:TMEM-MRIFNA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tumor permeability assessed by TMEM-MRI
Measured over Cohort B: ~14 days following breast biopsy and signing of consent. Cohort C: After neoadjuvant therapy and signing of consent and 0-56 days before surgery

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jesus Anampa, MD, MS · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Jesus Anampa, MD, MS
[email protected]
7184058505
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

For pre-pilot phase (MRI sequence development):
For pilot phase Cohort A:
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

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.

What this trial measures

  • Tumor permeability assessed by TMEM-MRICohort B: ~14 days following breast biopsy and signing of consent. Cohort C: After neoadjuvant therapy and signing of consent and 0-56 days before surgery

    Tumor permeability will be assessed by TMEM-MRI, and is defined as a number of Uth units (the number of tumor voxels with permeability density above threshold divided by the number of all tumor voxels) that will be obtained from the permeability map and TMEM-MRI algorithm.