Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer

PRIMARY OBJECTIVES:

I. To implement quantitative dynamic contrast-enhanced (DCE)-MRI, diffusion-weighted
(DW)-MRI, 31 phosphorus (31P) MRS, magnetization transfer (MT)-MRI, chemical exchange
saturation transfer (CEST)-MRI, and high-resolution structural imaging at 7 Tesla in
patients for diagnosing breast tumors.

OUTLINE:

Patients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor
cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content
using MT-MRI, and cellular protein content using CEST-MRI. Diagnostic performance of one, or
a combination, of these metrics will be investigated in the context of breast cancer.

Inclusion Criteria:

- Subjects must have signed an approved consent form

- Must be at least 18 years old

- Subjects must have undergone x-ray mammography and/or ultrasonography

- Subjects must have undergone standard clinical (1.5 Tesla) MRI as part of their
standard-of-care diagnostic workup:

- To evaluate the extent of disease for a previously diagnosed cancer, or

- To evaluate a clinically suspected lesion that was occult on mammography and/or
ultrasonography, or

- Because the patient is considered high-risk (according to National Comprehensive
Cancer Network [NCCN] criteria)

- Subjects must be classified Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5

- Subjects must be scheduled for diagnostic biopsy to evaluate a lesion that measures
>10 mm in the greatest dimension.

Exclusion Criteria:

- Subjects who have distant metastases

- Subjects who have any type of bioimplant activated by mechanical, electronic, or
magnetic means (e.g., cochlear implants, pacemakers, neurostimulators,
biostimulators, electronic infusion pumps, aneurysm clip, etc), because such devices
may be displaced or malfunction

- Subjects who have any type of ferromagnetic bioimplant that could potentially be
displaced by the magnetic field of the MRI scanner

- Subjects who may have shrapnel imbedded in their bodies (such as from war wounds),
metal workers, and machinists (potential for metallic fragments in or near the eyes)

- Subjects with a history of renal disease (including renal cancer), diabetes, or human
immunodeficiency virus (HIV)

- Creatinine >= 1.5 times upper limit of normal

- Estimated glomerular filtration rate < 30 mL/min

- Subjects who are pregnant or breast-feeding; the MRI Procedure Screening Form will be
used to identify and exclude subjects who are pregnant or breastfeeding; a urine
pregnancy test/or serum human chorionic gonadotropin (HCG) will also be performed for
pre-menopausal women who are not using contraceptives

- Subjects who have exhibited past allergic or other adverse reactions in response to
intravenous injection of Magnevist (gadopentetate dimeglumine) or other
gadolinium-containing contrast agents

- Subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe
vertigo when they are moved into the magnet bore

- Subjects incapable of giving informed written consent, for the following reasons:

- Inability to adhere to the experimental protocols for any reason

- Inability to communicate with the research team

- Limited ability to give informed consent due to mental disability, altered
mental status, confusion, or psychiatric disorders

- Prisoners or other individuals deemed to be susceptible to coercion