Dataset related to "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 dataset relates to a paper which 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 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

Dielectric Characterization of Breast Biopsied Tissues as Pre-Pathological Aid in Early Cancer Detection: A Blinded Feasibility Study

Dielectric characterization has significant potential in several medical applications, providing valuable insights into the electromagnetic properties of biological tissues for disease diagnosis, treatment planning, and monitoring of therapeutic interventions. This work presents the use of a custom-designed electromagnetic characterization system, based on an open-ended coaxial probe, for discriminating between benign and malignant breast tissues in a clinical setting. The probe’s development involved a well-balanced compromise between physical feasibility and its combined use with a reconstruction algorithm known as the virtual transmission line model (VTLM). Immediately following the biopsy procedure, the dielectric properties of the breast tissues were reconstructed, enabling tissue discrimination based on a rule-of-thumb using the obtained dielectric parameters. A comparative analysis was then performed by analyzing the outcomes of the dielectric investigation with respect to conventional histological results. The experimental procedure took place at Complejo Hospitalario Universitario de Toledo—Hospital Virgen de la Salud, Spain, where excised breast tissues were collected and subsequently analyzed using the dielectric characterization system. A comprehensive statistical evaluation of the probe’s performance was carried out, obtaining a sensitivity, specificity, and accuracy of 81.6%, 61.5%, and 73.4%, respectively, compared to conventional histological assessment, considered as the gold standard in this investigation

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

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

MammoWave Breast Imaging Device: An International and Multicentric Clinical Investigation

This work presents the first multicentric, single arm, prospective study to evaluate the ability of MammoWave, a microwave imaging prototype, in breast lesions detection. This study was the first breast microwave imaging study during which both symptomatic and asymptomatic subjects were recruited. MammoWave output consists of a selection of microwave images’ features, determined prior to the beginning of the trials, to quantify images’ non-homogenous behavior. Our results on 382 breasts show a sensitivity of 82% using a statistical significance of p<0.05, indicating MammoWave’s ability in distinguishing breasts with and without radiological findings. This prospective clinical trial may pave the way for introducing microwave imaging into clinical practice, for assisting in identification of breast lesions in asymptomatic women of all ages, without safety limitations

Dielectric Characterization of Small Breast Biopsy Via Miniaturized Open-Ended Coaxial Probe

The classification between normal and malignant tissues based on the use of an open-ended coaxial probe reveals an advantageous rapid support to traditional biopsy. The present work proposes an assessment of small biopsy breast dielectric characterization with our custom-designed open-ended coaxial probe. To this end, this study was accomplished by means of numerical simulations; results were confirmed by experimental measurements, performed at the University Hospital in Toledo

Automated Breast Tissue Classification Through Machine Learning Using Dielectric Data

In recent years, new technologies focused on dielectric principles have been developed for medical applications. Conductivity and permittivity of biological tissues have been described to vary among benign and malignant tissues, so many efforts are being made to implement new systems based on safe low-power microwaves able to capture these inhomogeneities for medical imaging. However, such conductivity and permittivity parameters are being investigated for several different applications. The dielectric characterization of tissues in vivo during surgeries or via excised tissue may offer clinicians new tools for optimizing hospital routines in the diagnostic pathway. This work presents the application of several Machine Learning (ML) approaches to dielectric data gathered from excised breast tissues using a novel open-ended coaxial probe