Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients

This is a prospective pilot study investigating the use of Automated Breast Ultrasound in
the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator
intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a
relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast
cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast
cancer. The research will take place at the University of Kansas Medical Center (KUMC). The
research study will be open to newly diagnosed breast cancer patients who present to KUMC
with a recommendation for preoperative MRI and who fit all inclusion criteria and have none
of the exclusion criteria.

Inclusion Criteria:

- Women (age 18-100) undergoing preoperative evaluation at the University of Kansas
Cancer Center (KUCC) for a new diagnosis of breast cancer

- Patients with a diagnosis of breast cancer by either core needle biopsy or excisional
biopsy.

- Bilateral mammography and hand-held ultrasound (if clinically indicated) performed
prior to the MRI and ABUS.

- If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and
ABUS will performed at KUCC (Study Arm 1).

- If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study
Arm 2).

- The MRI and ABUS exam must be obtained within 2 weeks of each other.

Exclusion Criteria:

- Males

- Pregnant women

- Lactating women

- Patients < 18 and > 100 years of age

- Patients with breast implants