Trial Information

Breast MRI Protocol

OBJECTIVES: I. Evaluate the performance of breast magnetic resonance imaging (MRI) in
conjunction with mammography for the detection and characterization of lesions in women with
suspicious mammographic or clinical examinations. II. Assess the incremental value of breast
MRI to determine the local extent of cancer in these patients. III. Assess the value of
breast MRI to determine the prevalence and characteristics of incidental enhancing lesions
in the remainder of the breast.

OUTLINE: This is a multicenter study. Patients undergo a high resolution 3D post contrast
magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a
dynamic scan no less than 18 hours later. Some patients may require a third scan if a core
biopsy is to be performed. Patients who are ultimately found to have cancer are assessed for
extent of cancer including measurement of the index lesion and identification of other
present foci of cancer in relation to the index lesion. Further histological diagnosis of
index lesions is determined by MRI-guided needle localization excisional biopsy. Patients
with benign needle biopsy are followed for 2 years. Patients with benign primary lesions
receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary
lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with
negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent
excisional biopsy are followed yearly for 2 years.

PROJECTED ACCRUAL: A total of 1500 patients will be accrued for this study over 4.25 years.