Microwave Breast Lesion Classification – Results from Clinical Investigation of the SAFE Microwave Breast Cancer System

Rationale and Objectives: Microwave breast cancer imaging (MWI) is an emerging non-invasive technology used to clinically assess the internal breast tissue inhomogeneity. MWI utilizes the variance in dielectric properties of healthy and cancerous tissue to identify anomalies inside the breast and make further clinical predictions. In this study, we evaluate our SAFE MWI system in a clinical setting. Capability of SAFE to provide breast pathology is assessed. Materials and Methods: Patients with BI-RADS category 4 or 5 who were scheduled for biopsy were included in the study. Machine learning approach, more specifically the Adaptive Boosting (AdaBoost) model, was implemented to determine if the level of difference between backscattered signals of breasts with the benign and malignant pathological outcome is significant enough for quantitative breast health classification via SAFE. Results: A dataset of 113 (70 benign and 43 malignant) breast samples was used in the study. The proposed classification model achieved the sensitivity, specificity, and accuracy of 79%, 77%, and 78%, respectively. Conclusion: The non-ionizing and non-invasive nature gives SAFE an opportunity to impact breast cancer screening and early detection positively. Device classified both benign and malignant lesions at a similar rate. Further clinical studies are planned to validate the findings of this study.