In addition to mammography, ultrasound imaging has become an important tool in the fight against breast cancer, a disease which in 2011 took an estimated 39,520 lives and added 288,130 new cases, in the US alone [1]. Breast ultrasound has been a proven tool for early breast cancer detection, however it has been hindered by its results quality significant dependency onthe operator's skill, among other limitations [2].It is inherently difficult to assess the completeness of freehand breast ultrasound scans [3] in order to avoid missing...

A realistic breast ultrasound phantom (Computerized Imaging Reference Systems Inc., Norfolk, VA, USA) was used with the FHUMS (Metritrack LLC, Hilside, IL, USA) and an ultrasound machine with a linear 12 MHz probe to generate the SBC and SAM. The FHUMS uses multiple magnetic sensors to perform the 3D mapping of the ultrasound probe and the patient's body and breast. An experienced ultrasound operator mapped the SBC and SAM with the phantom aligned with the exam table as shown in Fig. 1. The ultrasound cumulated...

The SBC manual measurement was 17,200 mm2, average area with the FHUMS was 17,870 mm2 and SD 206 mm2. The AD, PAD, AE and SD were: 3.9% (670 mm2), 1.4% (207 mm2), 3.7% and 1.1%, respectively. The LD, AE and SD were 1.2% (1.6 mm) and 0.8% (1.1) mm, respectively. The DR was 100% in 10 measurements, with AE, SD: 2mm2, 1.2mm2

The FHUMS automated contour and surface mapping performance testing with a realistic breast phantom and positional changes to simulate clinical conditions, showed anaccuracy and precision of less than 4% and 1.4% feasible for clinical applications, respectively. The SBC was slightly overestimated, which can be compensated in real patient applications. The detection and mapping of small surface areas not covered with the ultrasound probe, inside the SBC, can allow the ultrasound user to rescan the missed areas and provide a measure of completeness during the images...

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[1]American Cancer Society. Breast Cancer Facts & Figures 2011-2012. American Cancer Society, Inc.at http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-030975.pdf [2] Wendie A. Berg, MD, PhD et al., Operator Dependence of Physician-performed Whole-Breast US: Lesion Detection and Characterization,Radiology:Volume 241: Number 2—November 2006 [3] Automated Breast Ultrasound. Meeting of the Radiological Devices Advisory Panel, P110006,www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/RadiologicalDevicesPanel/UCM299908.pdf April 11, 2012.