On-Site Validation of a Microwave Breast Imaging System, before First Patient Study

Abstract

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.

Breast Cancer Detection—A Synopsis of Conventional Modalities and the Potential Role of Microwave Imaging

“…Early reports from an ongoing clinical study at the Clinical Research Facility of Galway University Hospital (CRFG) have been described [76,77]. The Wavelia system is a low-power electromagnetic wave operational system consisting of two subsystems, both performing a non-compressive, non-invasive breast examination.…”

Wavelia Breast Imaging: The Optical Breast Contour Detection Subsystem

“…As it involves microwave technology, so non-ionizing radiation, it may allow for diagnosis and follow-up of rapidly evolving pathologies by making it possible to safely schedule regular 3D scans of the breast as often as required [1,2]. Given the incorporated radar detection technology [3], this novel imaging modality is also meant to provide the clinicians with a useful tool for automated Computer-Aided Diagnosis (CAD). The hardware modules integrated in Wavelia are partly inherited from the technical background and expertise of the company in antenna measurement systems [4,5].…”

“…The hardware modules integrated in Wavelia are partly inherited from the technical background and expertise of the company in antenna measurement systems [4,5]. A detailed presentation of the actual R&D status of the system has been reported in [3].…”

“…Wavelia is now installed at Galway University Hospital, Ireland, for a first-in-human clinical investigation which started running in the last quarter of 2018. Prior to the initiation of the clinical investigation, on-site validation [3] has been performed using breast phantoms [6]. The pilot study holds full approval by the Local Ethics Committee, and the Health Products Regulatory Authority (HPRA), in Dublin, Ireland.…”

A Discrete Dipole Approximation Solver Based on the COCG-FFT Algorithm and Its Application to Microwave Breast Imaging

“…Investigations into 3D imaging are considerably more common than that for 2D because of the superior measurement model match despite the associated costs [16,19]. For many groups investigating microwave imaging, the amount of 2 International Journal of Antennas and Propagation measurement data required is often a significant barrier to real 3D implementations [20,21]. For most numerical techniques, solving the 3D imaging problem can be computationally expensive and requires use of multiprocessor computers working over many hours to even days to generate single images [16,22].…”