A Study to Evaluate 3.0 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women
Life time risk of developing breast cancer is greatly elevated in women with familial breast
cancer, especially in BRCA carriers. Prevention and early detection strategies in these
high risk women include risk reducing surgery, chemoprevention and close surveillance with
semiannual clinical breast exams and yearly mammograms starting at age 25-35. Unfortunately,
screening mammography detects only half the breast cancers in mutation carriers, presumably
due to higher breast density in the younger women and perhaps due to inherent
characteristics of their tumors such as rapid growth. In light of these limitations in this
high risk group, some have suggested incorporation of semiannual mammograms and/or other
imaging modalities such as ultrasound (US) and MRI.
In this study, high risk women who have a suspicious mammographic lesion - categorized as
Breast Imaging Reporting and data System (BI-RADS) 4 will be recruited to undergo a breast
MRI before to a biopsy of the suspicious abnormality. All women will undergo a biopsy as a
part of her standard of care. The results of the MRI will not influence our decision on
whether a biopsy should be performed. The MRI results will be compared with the biopsy
results with pathology as the gold standard.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI
This is the frequency of mammographically occult breast cancer detected by 3.0-T MRI in a subset of high risk women with a suspicious mammographically detected lesion.
Linda Moy, MD
New York University School of Medicine
United States: Institutional Review Board
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