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):

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.
The tumor should be considered operable by the breast surgeon.
No preoperative therapy for the current breast cancer is planned (endocrine therapy, chemotherapy, or radiation).
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.
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. 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.