Microwave Imaging in Breast Cancer – Results from the First-In-Human Clinical Investigation of the Wavelia System

Abstract

Rationale and Objectives: Microwave Breast Imaging (MBI) is an emerging non-ionising technology with the potential to detect breast pathology. The investigational device considered in this article is a low-power electromagnetic wave MBI prototype that demonstrated the ability to detect dielectric contrast between tumour phantoms and synthetic fibroglandular tissue in preclinical studies. Herein, we evaluate the MBI system in the clinical setting. The capacity of the MBI system to detect and localise breast tumours in addition to benign breast pathology is assessed. Secondly, the safety profile and patient experience of this device is established.Materials and Methods: Female patients were recruited from the symptomatic unit to 1 of 3 groups: Biopsy-proven breast cancers (Group-1), unaspirated cysts (Group-2) and biopsy-proven benign breast lesions (Group-3). Breast Density was determined by Volpara VDM (Volumetric Density Measurement) Software. MBI, radiological, pathological and histological findings were reviewed. Subjects were surveyed to assess patient experience.Results: A total of 25 patients underwent MBI. 24 of these were included in final data analysis (11 Group-1, 8 Group-2 and 5 Group-3). The MBI system detected and localised 12 of 13 benign breast lesions, and 9 out of the 11 breast cancers. This included 1 case of a radiographically occult invasive lobular cancer. No device related adverse events were recorded. 92% (n = 23) of women reported that they would recommend MBI imaging to other women. Conclusion:The MBI system detected and localized the majority of breast lesions. This modality may have the potential to offer a noninvasive, non-ionizing and painless adjunct to breast cancer diagnosis. Further larger studies are required to validate the findings of this study.

Automated Breast Lesion Detection and Characterization with the Wavelia Microwave Breast Imaging System: Methodological Proof-of-Concept on First-in-Human Patient Data

“…The Wavelia MBI Quantitative Imaging Function (QIF) was initially conceived using experimental MBI datasets from anthropomorphic breast phantoms [13,15] and was further developed and configured following training on the available FiH patient datasets [12,16]. The MBI parametric radar image formation and clinical feature extraction are performed offline at this stage of development of Wavelia.…”

“…The MBI morphological images (i.e., ROIs detected and validated based on morphological properties and persistence) are superimposed with the outer surface of the breast, as reconstructed using the auxiliary Wavelia Optical Breast Contour Detection (OBCD) subsystem, in Figure 12a for the four patient test cases. The Wavelia OBCD subsystem which is employed to reconstruct the external surface of the breast with high resolution, based on optical data, was earlier introduced in [12,13,16]. This superposition serves to better highlight the location of the MBI breast lesion detection with reference to the nipple of the breast, which is visible in the OBCD reconstruction.…”

“…Ultrasound, MRI and core biopsy data were also collected as a reference and were available as part of the patient's standard of care. In this FiH study, Wavelia demonstrated the capacity to detect and approximate underlying breast abnormalities to the appropriate location, in patients with palpable biopsy-confirmed invasive carcinomas and benign breast lesions, such as cysts and fibroadenomas [12]. The device also demonstrated promising results in delineating the size and malignancy risk of the detected breast lesions [14].…”

“…To date, a total of at least 10 MBI system prototypes have been employed in human subject tests, to investigate the clinical utility of MBI [8][9][10][11]. Despite encouraging clinical results being reported, several recurrent limitations, as outlined in [12], remain unresolved across most studies and justify further clinical research with alternative MBI systems, such as Wavelia.…”

“…In the Wavelia FiH clinical investigation [12], female patients were recruited from the symptomatic unit to one of three groups: Biopsy-proven breast cancers (Group-1), unaspirated cysts (Group-2) and biopsy-proven benign breast lesions (Group-3). For the training of the 2 classifiers:…”