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

Inclusion criteria

• For pre-pilot phase (MRI sequence development):
• 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:
• 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.