RecruitingNot ApplicableNCT03694756

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

TMEM-MRI: A Pilot Feasibility Study of Magnetic Resonance Imaging for Imaging of TMEM (Tumor Microenvironment of Metastasis) in Patients With Operable Breast Cancer

Sponsor

Montefiore Medical Center

Enrollment

95 participants

Start Date

Dec 12, 2018

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria25

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 Criteria5

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.

Interventions

DEVICETMEM-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.

PROCEDUREFNA

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).