The Clinical Utility of a Hand-Held Piezoelectric Scanner in the Detection of Early Tumor and Changes in Breast Texture.

Background Breast cancer (BC) is one of the leading causes of cancer death in females worldwide. Screening with mammography (MMG) is limited in low- and middle-income countries (LMICs). The implementation of an affordable and effective screening method is crucial. The intelligent breast examination (iBE) has emerged as a portable device with a glove shape using piezoelectricity. This experimental study evaluates the effectiveness of the device by comparing it with mammography (MMG), breast magnetic resonance imaging (MRI), and clinical breast examination (CBE). Methods This study included patients admitted to the senology unit who were under surveillance in a medical oncology unit. iBE was performed after each CBE and compared with Breast Image Reporting and Data System (BI-RADS) classifications. MMG/MRI was classified as negative (BI-RADS ≤2) or positive (BI-RADS ≥3). Measures of accuracy and agreement between tests were calculated. Results A total of 103 females were included between September 2022 and September 2023, who underwent iBE, CBE, and MMG/MRI. CBE and MMG showed moderate agreement in categorization (ρ=0.99). With a specificity for predicting a negative MMG of 90.8% and a negative predictive value of 79.7%. Benign findings, cysts, fibroadenoma, and benign microcalcifications were presented in 80 patients (seromas and non-suspicious hypoechogenic images). The performance of iBE was evaluated by comparing the breast with alterations to the control breast within each BI-RADS categorization. Conclusion As of now, iBE does not identify breast changes. The improvement proposals emphasized the incorporation of accelerometer sensors, signal conditioning to allow for the collection of compression and decompression data from the sensors, and consideration of pressure stress. These improvements are crucial to optimize the iBE's ability to detect changes in breast texture, enhancing the iBE's effectiveness in the early detection of BC.