Early detection of breast cancer has reduced mortality in women through the widespread implementation of screening mammography. However, challenges still exist in 40% of women with dense breasts, which reduces the mammographic sensitivity and detection of almost one-third of breast cancers. Automated breast (AB) ultrasound (US) has been proposed for screening women with dense breasts, enabling three-dimensional (3D) visualization, improved reproducibility, and reduction in operator dependence, compared to handheld US. However, ABUS systems require operator training for highquality image acquisition, experienced interpretation, and are costly. We propose an alternative, adaptable, and costeffective spatially tracked 3DUS system for automated whole-breast imaging. This paper describes the system design, optimization of 3D spatial tracking, multi-image registration and fusion of 3DUS acquired images in a tissue-mimicking breast phantom, and the first proof-of-concept healthy volunteer study. In the tissue-mimicking breast phantom, wholebreast 3DUS imaging and multi-planar visualization in axial, sagittal, and coronal views were demonstrated with the multiimage registration and fusion of acquired spatially tracked 3DUS images. The first clinical use of the spatially tracked 3DUS system was demonstrated in a healthy male and female volunteer study, showing high-resolution multi-image registration and fusion of two acquired 3DUS images. With an optimized acquisition protocol, our proposed spatially tracked system shows potential utility for automated whole-breast 3DUS imaging as a bedside point-of-care (POC) approach, toward improving widespread, accessible imaging in women with dense breasts.
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