Comparison of Diagnostic Accuracy of Automated Volume Breast Scanner to Hand Held Ultrasound for Diagnostic Breast Exam
Comparison of Diagnostic Accuracy of Automated Volume Breast Scanner to Hand Held Ultrasound for Diagnostic Breast Exam
Women age >18 scheduled for a diagnostic ultrasound examination had both a hand held
 ultrasound and an automated breast volume scan. Exams were performed by different
 technologists. Images were blinded and blinded read for diagnostic accuracy of the two
 examinations
Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a palpable
 mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were asked to
 participate in the study. If the patient had both a palpable mass and a mammogram that had an
 abnormality the indication was listed as a palpable abnormality. Exclusion criteria included
 inability to give informed consent and abnormality of the breast that is larger than one
 quadrant. No patients were excluded from the study.

 All patients received both a Hand Held (HH) and Automated Breast Volume Scanner (ABVS)
 ultrasound. Patients were initially randomized to have either a HH or an ABVS. The HH
 ultrasound was performed by one of 4 sonographers that had a minimum of 10 years experience
 in breast ultrasound. A different sonographer than the one performing the HH or mammography
 technician performed ABVS. All technologists performing ABVS participated in a training
 course on ABVS and performed at least 10 patients satisfactorily before beginning the study.
 The choice of a mammography technician or sonography to perform the ABVS was randomized. Both
 the sonographer performing the HH and the sonographer or mammography technologist performing
 the ABVS were provided the patient's history and results of the mammogram if performed for
 placement of the ABVS and region of interest for the HH. However the results of the HH or
 ABVS were not available to the person performing the second examination.

 Final diagnosis was performed either by a 12 gauge core biopsy (Celero, Hologic, Marlborough,
 MA ) or confirmation of a benign lesion by no significant change over 2 years.
Inclusion Criteria:

 -  Women aged 18 years and above presenting for a diagnostic ultrasound secondary to a
 palpable mass, abnormal mammogram, follow-up ultrasound abnormality, or discharge were
 asked to participate in the study.

 Exclusion Criteria:

 -  Unable to give informed consent

 -  breast abnormality greater than one quadrant