Recruiting

TMEM-MRI

Sponsor:

Montefiore Medical Center

Code:

NCT03694756

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TMEM-MRI

FNA

Study Details

Brief summary:

The aim of this study is to assess feasibility of a new imaging technology in the management of breast cancer - Tumor Microenvironment of Metastasis - Magnetic Resonance imaging (TMEM-MRI).

Conditions

Breast Cancer

Study ID

NCT03694756

Start date

Dec 12, 2018

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

95 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Pre-biopsy patients (Cohort A)

Patients identified by radiologist at the time of diagnostic evaluation and TMEM-MRI scheduled. After TMEM-MRI, the patient will undergo core biopsy as per usual radiology procedure, with additional fine-needle aspiration (FNA) preceding the core biopsy). After the breast biopsy confirms the suspected diagnosis of invasive breast carcinoma, the patient will be referred to breast surgery and a treatment plan devised per National Comprehensive Cancer Network/American Society of Clinical Oncology (NCCN/ASCO) guidelines.

No patients were enrolled into this arm/group and Cohort A has been removed by protocol amendment. This was intended to be a cohort for patients before breast biopsy in the event the biopsy procedure created a hematoma which would, in turn, affect measurement of TMEM-MRI activity. Since this effect was not observed in the first set of patients enrolled, Cohort A was removed from the study and only patients post-breast biopsy were enrolled (Cohort B).

other: Post-biopsy patients (Cohort B)

Patients after breast biopsy. Once consent is obtained, patients will undergo TMEM-MRI. The patients will undergo definitive breast surgery and will receive adjuvant treatments as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be evaluated in final surgical specimen. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.

other: Post-neoadjuvant therapy patients (Cohort C)

Patients status post neoadjuvant therapy. Patients who received neoadjuvant will be enrolled into Cohort C to understand the correlation between TMEM MRI activity and TMEM doorway density following after neoadjuvant chemotherapy. Only patients with residual palpable mass on physical exam will be included (≥ 1cm). Patients will undergo TMEM-MRI after neoadjuvant therapy is completed. Patients will also have CTCs and circulating tumor DNA (ctDNA) measured on the same day of TMEM-MRI (+/- 3 days). TMEM density, MenaCalc and MenaINV will be evaluated in breast surgical specimen (after pre-operative therapy). Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV after pre-operative therapy.

Interventions

TMEM-MRI

TMEM MRI INFORMATION: Unilateral breast MRI will be obtained on a 3.0T whole body MRI scanner with a dedicated breast radiofrequency coil. The patient will be scanned in the prone position with an in-dwelling IV catheter for a single dose contrast agent injection.

FNA

FNA: The patients who are recruited prior to biopsy (Cohort A) will have had TMEM-MRI performed prior to biopsy. They will then present to radiology for ultrasound-guided core biopsy of the breast mass. FNA will be performed during this procedure. The FNA will be performed after local anesthetic is administered but prior to insertion of the core biopsy needle. FNA will be performed by the radiologist under direct sonographic visualization of the mass. Five passes will be obtained with a 25-gauge needle. The FNA material will be expelled into 1.5 ml Eppendorf tube containing phosphate buffered saline with Ethylenediaminetetraacetic acid (EDTA).

Primary outcome measure

  • Tumor permeability assessed by TMEM-MRI [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Jesus Anampa, MD, MS

7184058505janampa@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Jesus D Anampa, MD,MS

718-405-8505janampa@montefiore.org

Karen Fehn, RN

7184058505kfehn@montefiore.org

Principal Investigator:

Jesus Anampa, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • TMEM;
  • Magnetic resonance imaging (MRI)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.