| Autor: |
Álvarez Sánchez-Bayuela D; Breast Imaging Department, Radiology Service, Complejo Hospitalario Universitario de Toledo, 45007 Toledo, Spain.; Faculty of Chemical Science and Technology, Instituto Regional de Investigación Científica Aplicada, University of Castilla-La Mancha, 13001 Ciudad Real, Spain., Ghavami N; UBT-Umbria Bioengineering Technologies, 06081 Perugia, Italy., Romero Castellano C; Breast Imaging Department, Radiology Service, Complejo Hospitalario Universitario de Toledo, 45007 Toledo, Spain., Bigotti A; UBT-Umbria Bioengineering Technologies, 06081 Perugia, Italy., Badia M; UBT-Umbria Bioengineering Technologies, 06081 Perugia, Italy., Papini L; UBT-Umbria Bioengineering Technologies, 06081 Perugia, Italy., Raspa G; UBT-Umbria Bioengineering Technologies, 06081 Perugia, Italy., Palomba G; UBT-Umbria Bioengineering Technologies, 06081 Perugia, Italy., Ghavami M; School of Engineering, London South Bank University, London SE1 0AA, UK., Loretoni R; AUSL Umbria 2, 06034 Foligno, Italy., Calabrese M; IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy., Tagliafico A; IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy.; Department of Health Sciences, University of Genoa, 16126 Genoa, Italy., Tiberi G; UBT-Umbria Bioengineering Technologies, 06081 Perugia, Italy.; School of Engineering, London South Bank University, London SE1 0AA, UK. |
| Abstrakt: |
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. |
