Developing Artefact Removal Algorithms to Process Data from a Microwave Imaging Device for Haemorrhagic Stroke Detection.

In this paper, we present an investigation of different artefact removal methods for ultra-wideband Microwave Imaging (MWI) to evaluate and quantify current methods in a real environment through measurements using an MWI device. The MWI device measures the scattered signals in a multi-bistatic fashion and employs an imaging procedure based on Huygens principle. A simple two-layered phantom mimicking human head tissue is realised, applying a cylindrically shaped inclusion to emulate brain haemorrhage. Detection has been successfully achieved using the superimposition of five transmitter triplet positions, after applying different artefact removal methods, with the inclusion positioned at 0°, 90°, 180°, and 270°. The different artifact removal methods have been proposed for comparison to improve the stroke detection process. To provide a valid comparison between these methods, image quantification metrics are presented. An "ideal/reference" image is used to compare the artefact removal methods. Moreover, the quantification of artefact removal procedures through measurements using MWI device is performed.

Experimental Validation of Microwave Tomographywith the DBIM-TwIST Algorithm for Brain StrokeDetection and Classification.

We present an initial experimental validation of a microwave tomography (MWT) prototypefor brain stroke detection and classification using the distorted Born iterative method, two-stepiterative shrinkage thresholding (DBIM-TwIST) algorithm. The validation study consists of firstpreparing and characterizing gel phantoms which mimic the structure and the dielectric propertiesof a simplified brain model with a haemorrhagic or ischemic stroke target. Then, we measure theS-parameters of the phantoms in our experimental prototype and process the scattered signals from 0.5to 2.5 GHz using the DBIM-TwIST algorithm to estimate the dielectric properties of the reconstructiondomain. Our results demonstrate that we are able to detect the stroke target in scenarios where theinitial guess of the inverse problem is only an approximation of the true experimental phantom.Moreover, the prototype can differentiate between haemorrhagic and ischemic strokes based on theestimation of their dielectric properties.

Microwave imaging for breast cancer screening: protocol for an open, multicentric, interventional, prospective, non-randomised clinical investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries.

INTRODUCTION: Microwave imaging presents several potential advantages including its non-ionising and harmless nature. This open, multicentric, interventional, prospective, non-randomised trial aims to validate MammoWave's artificial intelligence (AI)-based classification algorithm, leveraging microwave imaging, to achieve a sensitivity exceeding 75% and a specificity exceeding 90% in breast screening. METHODS AND ANALYSIS: 10 000 volunteers undergoing regular mammographic breast cancer screening will be recruited across 9 European centres and invited to participate in the clinical study, involving MammoWave testing on both breasts. MammoWave results will be checked against the reference standard, to be intended as the output of conventional breast examination path (with histological confirmation of cancer cases) with 2 years follow-up. Anonymised clinical and MammoWave's results, including microwave images, associated features and a label provided by the AI-based classification algorithm, will be collected and stored in a dedicated electronic case report form. The prospective study will involve a comparative analysis between the output of the conventional breast examination path (control intervention) and the labels provided by MammoWave's AI system (experimental intervention). These labels will categorise breasts into two groups: breast With Suspicious Finding, indicating the presence of a suspicious lesion or No Suspicious Finding, indicating the absence of a lesion or the presence of a low-suspicion lesion. This trial aims to provide evidence regarding the novel MammoWave's AI system for detecting breast cancer in asymptomatic populations during screening. ETHICS AND DISSEMINATION: This study was approved by the Research Ethics Committee of the Liguria Region (CET), Italy (CET-Liguria: 524/2023-DB id 13399), the Research Ethics Committee of Complejo Hospitalario de Toledo (CEIC), Spain (CEIC-1094), the National Ethics Committee for Clinical Research (CEIC), Portugal (CEIC-2311KC814), the Bioethical Committee of Pomeranian Medical University in Szczecin, Poland (KB-006/23/2024) and the Zurich Cantonal Ethics Commission, Switzerland (BASEC 2023-D0101). The findings of this study will be disseminated through academic and scientific conferences as well as peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06291896.

A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave's ability in breast lesions detection.

Microwave imaging is a safe and promising new technology in breast radiology, avoiding discomfort of breast compression and usage of ionizing radiation. This paper presents the first prospective microwave breast imaging study during which both symptomatic and asymptomatic subjects were recruited. Specifically, a prospective multicentre international clinical trial was performed in 2020-2021, to investigate the capability of a microwave imaging device (MammoWave) in allowing distinction between breasts with no radiological finding (NF) and breasts with radiological findings (WF), i.e., with benign or malignant lesions. Each breast scan was performed with the volunteers lying on a dedicated examination table in a comfortable prone position. MammoWave output was compared to reference standard (i.e., radiologic study obtained within the last month and integrated with histological one if available and deemed necessary by responsible investigator) to classify breasts into NF/WF categories. MammoWave output consists of a selection of microwave images' features (determined prior to trials' start), which allow distinction between NF and WF breasts (using statistical significance p<0.05). 353 women were enrolled in the study (mean age 51 years ± 12 [SD], minimum age 19, maximum age 78); MammoWave data from the first 15 women of each site, all with NF breasts, were used for calibration. Following central assessor evaluation, 111 NF (48 dense) and 272 WF (136 dense) breasts were used for comparison with MammoWave output. 272 WF comprised 182 benign findings and 90 malignant histology-confirmed cancer. A sensitivity of 82.3% was achieved (95%CI: 0.78-0.87); sensitivity is maintained when limiting the investigation to histology-confirmed breasts cancer only (90 histology-confirmed breasts cancer have been included in this analysis, having sizes ranging from 3 mm to 60 mm). Specificity value of approximately 50% was achieved as expected, since thresholds were calculated (for each feature) using median value obtained after recruiting the first 15 women (of each site), all NF. This prospective trial may represent another step for introducing microwave imaging into clinical practice, for helping in breast lesion identification in asymptomatic women.

A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Confirm MammoWave's Ability in Breast Lesions Detection.

Novel techniques, such as microwave imaging, have been implemented in different prototypes and are under clinical validation, especially for breast cancer detection, due to their harmless technology and possible clinical advantages over conventional imaging techniques. In the prospective study presented in this work, we aim to investigate through a multicentric European clinical trial (ClinicalTrials.gov Identifier NCT05300464) the effectiveness of the MammoWave microwave imaging device, which uses a Huygens-principle-based radar algorithm for image reconstruction and comprises dedicated image analysis software. A detailed clinical protocol has been prepared outlining all aspects of this study, which will involve adult females having a radiologist study output obtained using conventional exams (mammography and/or ultrasound and/or magnetic resonance imaging) within the previous month. A maximum number of 600 volunteers will be recruited at three centres in Italy and Spain, where they will be asked to sign an informed consent form prior to the MammoWave scan. Conductivity weighted microwave images, representing the homogeneity of the tissues' dielectric properties, will be created for each breast, using a conductivity = 0.3 S/m. Subsequently, several microwave image parameters (features) will be used to quantify the images' non-homogenous behaviour. A selection of these features is expected to allow for distinction between breasts with lesions (either benign or malignant) and those without radiological findings. For all the selected features, we will use Welch's t-test to verify the statistical significance, using the gold standard output of the radiological study review.

Metasurface-Enhanced Antennas for Microwave Brain Imaging.

Stroke is a very frequent disorder and one of the major leading causes of death and disability worldwide. Timely detection of stroke is essential in order to select and perform the correct treatment strategy. Thus, the use of an efficient imaging method for an early diagnosis of this syndrome could result in an increased survival's rate. Nowadays, microwave imaging (MWI) for brain stroke detection and classification has attracted growing interest due to its non-invasive and non-ionising properties. In this paper, we present a feasibility study with the goal of enhancing MWI for stroke detection using metasurface (MTS) loaded antennas. In particular, three MTS-enhanced antennas integrated in different brain scanners are presented. For the first two antennas, which operate in a coupling medium, we show experimental measurements on an elliptical brain-mimicking gel phantom including cylindrical targets representing the bleeding in haemorrhagic stroke (h-stroke) and the not oxygenated tissue in ischaemic stroke (i-stroke). The reconstructed images and transmission and reflection parameter plots show that the MTS loadings improve the performance of our imaging prototype. Specifically, the signal transmitted across our head model is indeed increased by several dB's over the desired frequency range of 0.5-2.0 GHz, and an improvement in the quality of the reconstructed images is shown when the MTS is incorporated in the system. We also present a detailed simulation study on the performance of a new printed square monopole antenna (PSMA) operating in air, enhanced by a MTS superstrate loading. In particular, our previous developed brain scanner operating in an infinite lossy matching medium is compared to two tomographic systems operating in air: an 8-PSMA system and an 8-MTS-enhanced PSMA system. Our results show that our MTS superstrate enhances the antennas' return loss by around 5 dB and increases the signal difference due to the presence of a blood-mimicking target up to 25 dB, which leads to more accurate reconstructions. In conclusion, MTS structures may be a significant hardware advancement towards the development of functional and ergonomic MWI scanners for stroke detection.

Breast lesion detection through MammoWave device: Empirical detection capability assessment of microwave images' parameters.

MammoWave is a microwave imaging device for breast lesions detection, which operates using two (azimuthally rotating) antennas without any matching liquid. Images, subsequently obtained by resorting to Huygens Principle, are intensity maps, representing the homogeneity of tissues' dielectric properties. In this paper, we propose to generate, for each breast, a set of conductivity weighted microwave images by using different values of conductivity in the Huygens Principle imaging algorithm. Next, microwave images' parameters, i.e. features, are introduced to quantify the non-homogenous behaviour of the image. We empirically verify on 103 breasts that a selection of these features may allow distinction between breasts with no radiological finding (NF) and breasts with radiological findings (WF), i.e. with lesions which may be benign or malignant. Statistical significance was set at p<0.05. We obtained single features Area Under the receiver operating characteristic Curves (AUCs) spanning from 0.65 to 0.69. In addition, an empirical rule-of-thumb allowing breast assessment is introduced using a binary score S operating on an appropriate combination of features. Performances of such rule-of-thumb are evaluated empirically, obtaining a sensitivity of 74%, which increases to 82% when considering dense breasts only.