PURPOSE: To evaluate the performance of an automated breast ultrasound  system (SomoVu) versus conventional hand-held ultrasonography by comparing lesion visibility and BIRADS Assessment.

MATERIALS AND METHODS: Patients presenting for diagnostic ultrasound were recruited and signed an IRB-approved informed consent. Lesions were imaged using mammography, hand-held ultrasonography (HHUS), and the SomoVu. Visibility of lesions using the SomoVu was compared with visibility of these same lesions using HHUS. BIRADS assessment using mammography plus HHUS was compared to BIRADS assessment using mammography plus SomoVu.

RESULTS: A total of 62 patients with 65 lesions have been enrolled to date. In these patients 94% of lesions visible on HHUS were also visible on SomoVu. Similarly, the BIRADS assessment derived from mammography plus SomoVu was in agreement with the BIRADS assessment derived from mammography plus HHUS in 94% of breasts analyzed. Each of the 15 biopsy-proven cancers in this series was visible on the SomoVu.

CONCLUSION: These preliminary results suggest that images made with SomoVu and HHUS have similar visibility and lead to similar BIRADS assessments in greater than 90% of breasts examined.