Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer

This research study is being done to test how well a contrast enhanced mammogram compares to
MRI in screening for breast cancer in people who are at higher risk for developing breast
cancer.

Standard screening mammograms can miss breast cancers due to its inability to "see through"
dense breast tissue. For this reason, women at increased risk for the development of breast
cancer often undergo additional screening beyond conventional mammography with magnetic
resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer,
it also finds many areas that are benign (not cancer). The only way to know which is the
cancer is to perform a biopsy, which contributes to patient anxiety and leads to many
unnecessary biopsies.

In the preliminary studies performed in women already diagnosed with breast cancer, contrast
enhanced mammography was shown to have a similar sensitivity for finding primary breast
cancer but detected fewer of the benign findings which would result in fewer unnecessary
biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography
was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on
standard mammography and ultrasound.

We are now studying to see if contrast enhanced mammography will also be a beneficial tool in
the screening setting to screen high risk patients for breast cancer.

Inclusion Criteria:

- Women

- Age > or equal to 30 years

- High risk (>20% lifetime risk)

- Has a bilateral mammogram within the last 7 months

- Has had a same day high risk screening MRI

Exclusion Criteria:

- Participants who have a known allergy or contraindication to iodinated contrast.

- Participants who have a known allergy to food or medications.

- Participants who have renal insufficiency or failure.

- Participants who are pregnant or breastfeeding.

- Participants with a concurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia.