Wavelia Microwave Breast Imaging Phase#2 Clinical Investigation: Methodological Evolutions and Multidimensional...

The Wavelia Microwave Breast Imaging (MWBI) technology aims to increase sensitivity in dense breasts, where X-ray mammography is of limited value. Its potential contribution to the reduction in the false positives in breast cancer diagnosis, by developing MWBI image descriptors supporting malignant-to-benign lesion discrimination, is also being investigated. After a First-In-Human (FiH) study with interesting findings on a small dataset of 24 symptomatic breast lesions, an upgraded 2nd prototype of Wavelia was manufactured and tested on a larger and more diverse dataset, including 62 patients and a balanced distribution of malignant and benign symptomatic breast lesions.

A set of technological and methodological evolutions, outlined in this article, was implemented in Wavelia#2 to handle the diversity in larger patient datasets. Multi-modal MWBI imaging is employed to parameterize the interaction mechanisms between the microwaves and the imaged breast at varying geometrical and tissue consistency conditions. MWBI Region-Of-Interest (ROI) extraction and characterization based on multidimensional radiomic feature vectors is implemented to expand the malignant-to-benign lesion diagnostics potential of MWBI compared to the limited scope of the FiH study with Wavelia#1, which employed three specific preselected features.

This study demonstrates significant diagnostic accuracy of multiple texture-based and intensity-based features to discriminate between malignant and benign breast lesions with Wavelia#2 MWBI. A phenomenological qualitative assessment of the false positive rate on healthy breasts is also presented for the MWBI technology for the first time.

The analysis contributes to the rationalization of the MWBI imaging and image analysis outputs towards standardization, objective interpretability, and ultimate clinical acceptance.