SAFE (Scan and Find Early) is a novel microwave imaging device intended for breast cancer screening and early detection. SAFE is based on the use of harmless electromagnetic waves and can provide relevant initial diagnostic information without resorting to X-rays. Because of SAFE’s harmless effect on organic tissue, imaging can be performed repeatedly. In addition, the scanning process itself is not painful since breast compression is not required. Because of the absence of physical compression, SAFE can also detect tumors that are close to the thoracic wall. A total number of 115 patients underwent the SAFE scanning procedure, and the resultant images were compared with available magnetic resonance (MR), ultrasound, and mammography images in order to determine the correct detection rate. A sensitivity of 63% was achieved. Breast size influenced overall sensitivity, as sensitivity was lower in smaller breasts (51%) compared to larger ones (74%). Even though this is only a preliminary study, the results show promising concordance with clinical reports, thus encouraging further SAFE clinical studies.

Background/Objectives: Breast cancer is a significant global health concern, and early detection is crucial for improving patient outcomes. Mammography is widely used but has limitations, particularly for younger women with denser breasts. These include reduced sensitivity, false positives, and radiation risks. This highlights the need for alternative screening methods. In this study, we assess the performance of SAFE (Scan and Find Early), a novel microwave imaging device, in detecting breast cancer in a larger patient cohort. Unlike previous studies that predominantly relied on cross-validation, this study employs a more reliable, independent evaluation methodology to enhance generalizability. Methods: We developed an XGBoost model to classify breast cancer cases into positive (malignant) and negative (benign or healthy) groups. The model was analyzed with respect to key factors such as breast size, density, age, tumor size, and histopathological findings. This approach provides a better understanding of how these factors influence the model’s performance, using an independent evaluation methodology for increased reliability. Results: Our results demonstrate that SAFE exhibits high sensitivity, particularly in dense breasts (91%) and younger patients (83%), suggesting its potential as a supplemental screening tool. Additionally, the system shows high detection accuracy for both small (<2 cm) and larger lesions, proving effective in early cancer detection. Conclusions: This study reinforces the potential of SAFE to complement existing screening methods, particularly for patients with dense breasts, where mammography’s sensitivity is reduced. The promising results warrant further research to solidify SAFE’s clinical application as an alternative screening tool for breast cancer detection.

(1) Background: Microwave breast imaging (MBI) is a promising breast-imaging technology that uses harmless electromagnetic waves to radiate the breast and assess its internal structure. It utilizes the difference in dielectric properties of healthy and cancerous tissue, as well as the dielectric difference between different cancerous tissue types to identify anomalies inside the breast and make further clinical predictions. In this study, we evaluate the capability of our upgraded MBI device to provide breast tissue pathology. (2) Methods: Only patients who were due to undergo biopsy were included in the study. A machine learning (ML) approach, namely Gradient Boosting, was used to understand information from the frequency spectrum, collected via SAFE, and provide breast tissue pathology. (3) Results: A total of 54 patients were involved in the study: 29 of them had benign and 25 had malignant findings. SAFE acquired 20 true-positive, 24 true-negative, 4 false-positive and 4 false-negative findings, achieving the sensitivity, specificity and accuracy of 80%, 83% and 81%, respectively. (4) Conclusions: The use of harmless tissue radiation indicates that SAFE can be used to provide the breast pathology of women of any age without safety restrictions. Results indicate that SAFE is capable of providing breast pathology at a high rate, encouraging further clinical investigations.