Abstract
PURPOSE: The aim of this study was to test a novel dual-modality imaging system that combines full-field digital mammography (FFDM) and automated breast ultrasound (ABUS) in a single platform. Our Aceso system, named after the Greek goddess of healing, was specifically designed for the early detection of cancer in women with dense breast tissue. MATERIALS AND METHODS: Aceso was first tested using two industry standards: a Contrast Detail Mammography (CDMAM) phantom as endorsed by European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services was used to assess the FFDM images; and the CIRS 040GSE ultrasound phantom was imaged to evaluate the quality of the ABUS images. In addition, 58 women participated in a clinical trial: 51 were healthy volunteers aged between 40 and 65, while 7 were patients referred by the breast clinic, 6 of whom had biopsy-proven breast cancer. RESULTS: The CDMAM tests showed that the FFDM results were "acceptable" but fell short of "achievable" which was attributed to the low dose used. The ABUS images had good depth penetration (80 mm) and adequate axial resolution (0.5 mm), but the lateral resolution of 2 mm was judged to be too coarse. In a 42-year-old volunteer with extremely dense breast tissue, the ABUS modality detected a lesion (a benign cyst) that was mammographically occult in the FFDM image. For a 73-year-old patient with fatty breasts, a malignant lesion was successfully detected and co-registered in the FFDM and ABUS images. On average, each woman spent less than 11 min in the acquisition room. CONCLUSIONS: While there is room for improvement in the quality of both the FFDM and ABUS images, Aceso has demonstrated its ability to acquire clinically meaningful images for a range of women with varying breast densities and, therefore, has potential as a screening device.