Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia

This research study is a Pilot Study, which is the first time investigators are examining
this study device for this purpose.

Atypical ductal hyperplasia (ADH) is a common diagnosis after breast biopsy. Although it is
not cancer itself, ADH can become breast cancer in some cases. As a result, surgery is
performed to remove ADH to make sure it doesn't progress to cancer. In many cases, no cancer
is found during the surgery.

Previous studies have shown that breast MRI may be able to predict which areas of ADH will be
cancer at the time of surgery. This would help prevent unnecessary surgery in some patients.

Contrast enhanced mammography is a new type of mammogram that is already being used in
clinical practice to help find breast cancer. Similar to breast MRI, it uses contrast
material combined with the mammogram to highlight areas that might be breast cancer and that
could be missed on the mammogram alone. Contrast material is a dye or other substance that
helps show abnormal areas within the body.

Studies have shown the contrast enhanced mammography has a similar ability to find breast
cancer as breast MRI.

The investigators purpose is to see whether contrast enhanced mammography can predict which
areas of ADH will become breast cancer at the time of surgery. The investigators believe this
will help prevent unnecessary surgery in many with women with the diagnosis of ADH.

Inclusion Criteria:

- Age, Minimum 30 years. CESM is an imaging exam that uses radiation and is not
typically employed in women younger than age 30 due to potentially negative biologic
effects on glandular breast tissue.

- Participants who had a percutaneous breast biopsy (to include stereotactic,
tomosynthesis, or ultrasound guided) that revealed ADH

- Participants will be undergoing surgical excision to remove the ADH.

- Participants must have normal organ and marrow function as defined by a GFR ≥60
mL/min/1.73 m2 to be performed per clinical protocol

- Patients ≥65 years without underlying renal insufficiency get GFR tested within 6
months of the exam.

- Patients < 65 years without underlying renal insufficiency do not require an GFR
calculation)

- Patients ≥65 years with known underlying renal insufficiency get GFR tested within 1
month of the exam.

- Patients < 65 years with known renal insufficiency get GFR tested within 1 month of
the exam.

- Because of the potential teratogenic effects of radiation, women of child-bearing
potential must agree to use adequate contraception (hormonal or barrier method of
birth control; abstinence) prior to study entry, until the CESM is performed. Should a
woman become pregnant or suspect she is pregnant, she should inform the study team
prior to getting the CESM.

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Participants with a core biopsy diagnosis of atypia with associated malignancy (in the
same quadrant) will be excluded.

- Participant had a breast MRI that was performed after the diagnosis of ADH but before
surgical excision

- Participants who have a known allergy to contrast media.

- Participants who have a known severe allergic response to one or more allergens, as
defined by anaphylaxis.

- Participants with persistent asthma as defined by the National Heart, Lung, and Blood
Institute.

- Participants with renal insufficiency or failure, as determined by a point of care
renal function blood test.

- Participants who are breastfeeding are excluded because there is an unknown but
potential risk for adverse events in nursing infants secondary to contrast
administration in the mother.

- Participants with the following underlying medical conditions: multiple myeloma,
myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary
pulmonary hypertension, cardiac arrythmia, or severe cardiomyopathy. These underlying
medical conditions may make the participant more likely to develop a contrast
reaction. This is based on the ACR contrast manual version 10.3 and hospital policy.

- Participants with thyroid carcinoma or thyroid disease for whom systemic radioactive
iodine therapy is part of planned diagnostic work-up or treatment within 2 months
following the contrast mammogram study.

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

- Pregnant women are excluded from this study because CESM uses radiation with the
potential for teratogenic or abortifacient effects. This will be defined by a urine
pregnancy test prior to the CESM study.