Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound

This is a research study to test a FDA-approved automated breast ultrasound (ABVS) machine
in subjects recommended for an ultrasound of the breast. The main purpose of the study is to
compare images obtained from the automated breast ultrasound exam with the standard
physician performed handheld breast ultrasound exam for lesion detection equivalence.

Each subject will have a bilateral hand-held breast ultrasound and a bilateral automated
breast ultrasound, both exams preferably done on the same day. The hand-held ultrasound will
be performed by a breast imaging physician participating in the study and the automated
ultrasound exam will be performed by a sonographer.

There is no radiation risk from ultrasound. The physician performing the handheld breast
ultrasound is blinded to the study, will not know the subject's history, but only the reason
for the breast ultrasound exam.

The automated scan requires gentle pressure on the breast during a scan. Three basic views
will be acquired for each breast, each scan lasting approximately one minute. Once all
necessary views are acquired, the images will be sent to a remote workstation, where a
second radiologist, also blinded to the results of the handheld study, will interpret the
automated ultrasound.

Once all images and patient information are gathered, the study radiologists will review the
previous images, if available, to provide the final result that will determine clinical
management. Therefore, it is possible that the hand-held or automated ultrasound scan will
lead to further evaluation of the breast and possibly a biopsy.

Inclusion Criteria:

- anyone who is referred for an ultrasound of the breast

Exclusion Criteria:

- Subjects whose breast thickness is greater than 6 cm.The maximum depth of image filed
for the ABVS acquisition is 6 cm