Effect of Body Position and Probe Position on the Localization of Breast Mass

The proposed research consists of quantitatively detecting and reporting the effect of body
rotation and ultrasound probe position on the breast on the position of breast lesions
relative to the breast nipple and body orientation planes, required for positional
annotations, in female subjects at one study visit. Measurements will be manually and
automatically recorded by two ultrasound operators with each image and will be compared among
these conditions to detect effects of probe position and probe orientation and patient's body
position relative to the exam table. The manual and automated measurements will be compared
to determine the differences between the data obtained using the two different methods.

Inclusion Criteria:

1. Female

2. 21-70 years of age

3. Known palpable or non-palpable benign or probably benign breast mass or masses, less
than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous
ultrasound examination

Exclusion Criteria:

1. Women with cardiac pacemaker or portable defibrillator

2. Women with known breast cancer or suspicious lesions

3. Pregnant and lactating women

4. Women who have breast implant(s)

5. Women who have had prior breast surgical intervention not including breast needle
biopsy, in the same breast with the qualifying target mass.

6. Women with the target finding to be mapped within a distance of 4 cm from patient's
nipple.

7. Women with multiple similar qualifying targets in close proximity (less than 4 cm
between targets).

8. Women with history of allergy to medical-grade adhesive tape or ultrasound gel

9. Women whose weight is over 250 pounds