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Microwave Breast Imaging (MBI) is an emerging non-ionizing imaging modality, with the potential to support breast diagnosis and management. Wavelia is an MBI system prototype, of 1st generation, which has recently completed a First-In-Human (FiH) clinical investigation on a 25-symptomatic patient cohort, to explore the capacity of the technology to detect and characterize malignant (invasive carcinoma) and benign (fibroadenoma, cyst) breast disease. Two recent publications presented promising results demonstrated by the device in this FiH study in detecting and localizing, as well as delineating size and malignancy risk, of malignant and benign palpable breast lesions. In this paper, the methodology that has been employed in the Wavelia semi-automated Quantitative Imaging Function (QIF), to support breast lesion detection and characterization in the FiH clinical investigation of the device, is presented and the critical design parameters are highlighted.

Wavelia is a low-power electromagnetic wave breast imaging device for breast cancer diagnosis, which consists of two subsystems, both performing non-invasive examinations: the Microwave Breast Imaging (MBI) subsystem and the Optical Breast Contour Detection (OBCD) subsystem. The Wavelia OBCD subsystem is a 3D scanning device using an infrared 3D stereoscopic camera, which performs an azimuthal scan to acquire 3D point clouds of the external surface of the breast. The OBCD subsystem aims at reconstructing fully the external envelope of the breast, with high precision, to provide the total volume of the breast and morphological data as a priori information to the MBI subsystem. This paper presents a new shape-based calibration procedure for turntable-based 3D scanning devices, a new 3D breast surface reconstruction method based on a linear stretching function, as well as the breast volume computation method that have been developed and integrated with the Wavelia OBCD subsystem, before its installation at the Clinical Research Facility of Galway (CRFG), in Ireland, for first-in-human clinical testing. Indicative results of the Wavelia OBCD subsystem both from scans of experimental breast phantoms and from patient scans are thoroughly presented and discussed in the paper.

This paper presents the Wavelia microwave breast imaging system that has been recently installed at the Galway University Hospital, Ireland, for a first-in-human pilot clinical test. Microwave breast imaging has been extensively investigated over the last two decades as an alternative imaging modality that could potentially bring complementary information to state-of-the-art modalities such as X-ray mammography. Following an overview of the main working principles of this technology, the Wavelia imaging system architecture is presented, as are the radar signal processing algorithms that are used in forming the microwave images in which small tumors could be detectable for disease diagnosis. The methodology and specific quality metrics that have been developed to properly evaluate and validate the performance of the imaging system using complex breast phantoms that are scanned at controlled measurement conditions are also presented in the paper. Indicative results from the application of this methodology to the on-site validation of the imaging system after its installation at the hospital for pilot clinical testing are thoroughly presented and discussed. Given that the imaging system is still at the prototype level of development, a rigorous quality assessment and system validation at nominal operating conditions is very important in order to ensure high-quality clinical data collection.