Wavelia Microwave Breast Imaging Phase#2 Clinical Investigation: Methodological Evolutions and Multidimensional Radi-Omics Analysis Towards Controlled Specificity

Background/Objectives: The Wavelia Microwave Breast Imaging (MWBI) technology aims at increased sensitivity in dense breasts where x-ray mammography is of limited value, while contributing to reduction of the false positives in breast cancer diagnosis, by developing MWBI image descriptors supporting malignant-to-benign lesion discrimination. 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. Methods: A set of technological and methodological evolutions, outlined in this article, were 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 multi-dimensional 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 3 specific, preselected, features. Results: The 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 positives rate on healthy breasts is also presented for the MWBI technology, for the first time. Conclusions: The analysis contributes to the rationalization of the MWBI imaging and image analysis outputs, towards standardization, objective interpretability and ultimate clinical acceptance.