Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

PRIMARY OBJECTIVES:

I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast
imaging.

II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard
ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and
construct reflection, sound speed and attenuation images with SoftVue.

III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal
landmark architecture) or masses previously identified with standard diagnostic evaluation
(palpation, mammography, standard US) using standard clock position and radial distance
measurements from the nipple.

IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance
imaging (MRI) findings from a subgroup of 50 patients.

OUTLINE:

Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the
breast.

Inclusion Criteria:

- Scheduled for mammogram, breast ultrasound and/or breast MRI

- Breast size less than 22 cm diameter (ring diameter is 22cm)

- Able to read or understand and provide informed consent

- Weight < 350lbs (patient bed max weight)

- Non-pregnant and non-lactating

- No open breast or chest wounds

- No active skin infection

- No serious medical or psychiatric illnesses that would prevent informed consent