Detection of Breast Lesions by Automatic Breast US
Detection of Breast Lesions by Automatic Breast US
Mammography is considered the standard imaging method for breast cancer screening, and is
 known to result in reduced mortality from breast cancer. However, the diagnostic yield of
 mammography depends particularly on breast tissue density, with sensitivity as low as 30-48%
 in dense-breast women. Ultrasound is an attractive adjunct imaging method to mammography as
 it is widely accessible, relatively inexpensive and well-tolerated by patients. The addition
 of hand-held ultrasound to mammography has been demonstrated to significantly increase breast
 cancer detection in women with dense breasts. It is however dependent on the expertise and
 skill of the operator.

 In recent years, the FDA has approved the use of the automated breast ultrasound (ABUS) for
 use in screening of women with dense breast. Unlike handheld ultrasound, the ABUS is
 relatively simple to use, necessitating less technical training, and results in higher
 reproducibility.

 The research aim is to evaluation of automated breast ultrasound (ABUS) regarding the
 detection and classification of breast lesions, compared to hand-held ultrasound, according
 to the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS)
 classification. The investigator will also evaluate parameters regarding patients' comfort,
 workflow, and duration of image interpretation.
ABUS produces a 3D volume acquisition using a 6-15 Mega Herz reverse curve transducer. Images
 are digitally reformatted on a dedicated workstation to produce axial, sagittal and coronal
 reformatted images. Unlike handheld ultrasound, the ABUS is relatively simple to use,
 necessitating less technical training, and results in higher reproducibility. Previous
 studies have shown that automated breast ultrasound is very well tolerated by patients can be
 useful in detection of solid and cystic lesions and in evaluating tumor extent
 preoperatively.

 Automated breast ultrasound will be performed on the "Invenia ABUS" (Automated Breast
 Ultrasound System) designed for automated breast imaging by General Electric (GE) Healthcare.
 Images will be acquired using a 15 centimeter field-of-view reverse curve ultra-broadband
 transducer of 6-15 Mega Herz. Using mechanical compression assist, the transducer is placed
 on each breast and six volumes are acquired with six sweeps (right anterior-posterior, right
 lateral, right medial; left anterior-posterior, left lateral, left medial). Acquisition time
 expected 15 minutes per patient, approximately 30-40 second acquisition per volume.

 ABUS examinations will be performed by the investigators institution's radiographers, with
 variable degrees of experience in performing hand-held breast ultrasound examinations (HHUS).

 Reformatted images and volumes will be view on a designated workstation of 2 megapixel high
 resolution monitor, using customized hanging protocols, multi-slice 3D viewing and patented
 clinical algorithms. Interpretation of images will be done by our institution's breast
 imaging radiologists with more than 15 years of experience in performing and reading
 hand-held breast ultrasound studies.

 Each breast will be assigned a final ABUS BI-RADS score according to the American College of
 Radiology classification ranging from 1 to 6. A discrepancy between the ABUS Breast
 Imaging-Reporting and Data System score and the hand-held ultrasound BI-RADS score (HHUS
 BI-RADS 1-2 & ABUS BI-RADS >2, or HHUS BI-RADS >3 & ABUS BI-RADS 1-2) will result in the
 referral of the woman to second-look hand-held ultrasound to determine the reason for the
 mismatch.
Inclusion Criteria:

 Women referred to hand-held screening ultrasound examination (BI-RADS=1/2). Women scheduled
 to undergo ultrasound-guided needle biopsy due to suspicious breast mass detected during
 hand-held ultrasound (BI-RADS>2).

 Exclusion Criteria:

 Women under 25 years.