Trial Information

Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner

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.