Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

Mammography is the main way to help find breast cancers early so they can be treated.
Unfortunately, mammography does not work as well in women who have dense breast tissue or who
are at high-risk for breast cancer. In these women, breast MRI is also used to help find
breast cancers.

Contrast enhanced mammography is a new type of mammogram. 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. This is similar to breast MRI.

For this study, participants who are already getting a breast biopsy will have a contrast
enhanced mammogram and a breast MRI before the biopsy. The participant's contrast enhanced
mammogram and breast MRI images will then be included within a large collection of images.
Radiologists will compare the images to see if the contrast enhanced mammograms and the
breast MRI find the same number of breast cancers. If the investigators find they perform
similarly, then contrast mammography may be used to aid in breast cancer screening in the
future.

Inclusion Criteria:

Prospective Patient Recruitment

- Women

- Age > or equal to 30 years

- Recommendation for breast biopsy has been made

- Recommendation for biopsy will result from an imaging work-up originating with a
screening exam (mammogram, tomosynthesis, ultrasound, or MRI) that was within 3 months
of biopsy.

Reader Study Inclusion Criteria:

- CESM and MRI exam performed within 3 months of one another.

- CESM and breast MRI exams must be performed as part of imaging work-up based on a
screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)

- CESM studies will include at least four low energy and four recombined images (LCC,
LMLO, RCC, RMLO).

- MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted

Exclusion Criteria:

Prospective Patient Recruitment

- Men

- Women with implants

- Participants who have a known allergy to contrast media.

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

- Participants with poor asthma control using the National Heart, Lung, and Blood
Institute guidelines as defined by:

Symptoms > 2 days per week Short-term beta agonist use > 2 days per week Nighttime
awakenings > 2 times per month

- Participants with Renal insufficiency or failure, as determined by GFR < 60
mL/min/1.73 m2 , performed for all patients within 24 hours of the imaging exams

- Participants who are pregnant. Pregnant women are excluded from this study due to the
radiation dose from the CT scan and its potential teratogenic effects on the fetus.

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

- 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 non-MR compatible objects or implants that would make MRI a
contraindication.

- Participants who have a pacemaker, pacer wires, implantable defibrillator, or
implanted monitoring device.

- Participants with intracranial clips, metal implants or external clips within 10 mm of
the head.

- Participants who have had a metal injury to the eye.

Reader Study Exclusion Criteria:

- Imaging sets with implants.

- Imaging sets in which a biopsy or surgical intervention was performed since the most
recent screening exam, prior to acquisition of the study MRI or CESM.

- Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2
year imaging follow-up is not available