The Wavelia Microwave Breast Imaging system–tumour discriminating features and their clinical usefulness

Abstract

Objective: The Wavelia Microwave Breast Imaging (MBI) system, based on non-ionising imaging technology, has demonstrated exciting potential in the detection and localisation of breast pathology in symptomatic patients. In this study, the ability of the system to accurately estimate the size and likelihood of malignancy of breast lesions is detailed, and its clinical usefulness determined. Methods: Institutional review board and Health Products Regulatory Authority (HPRA) approval were obtained. Patients were recruited from the symptomatic unit to three groups; Breast cancer (Group-1), unaspirated cysts (Group-2) and biopsied benign lesions (Group-3). MBI, radiological and histopathological findings were reviewed. MBI size estimations were compared with the sizes determined by conventional imaging and histopathology. A Quadratic Discriminant Analysis (QDA) classifier was trained in a 3D feature space to discriminate malignant from benign lesions. An independent review was performed by two independent breast radiologists. Results: 24 patients (11 Group-1, 8 Group-2 and 5 Group-3) underwent MBI. The Wavelia system was more accurate than conventional imaging in size estimation of breast cancers. The QDA accurately separated benign from malignant breast lesions in 88.5% of cases. The addition of MBI and the Wavelia malignancy risk calculation was deemed useful by the two radiologists in 70.6% of cases. Conclusion: The results from this MBI investigation demonstrate the potential of this novel system in estimating size and malignancy risk of breast lesions. This system holds significant promise as a potential non-invasive, comfortable, and harmless adjunct for breast cancer diagnosis. Further larger studies are under preparation to validate the findings of this study. Advances in knowledge: This study details the potential of the Wavelia MBI system in delineating size and malignancy risk of benign and malignant breast lesions in a symptomatic cohort. The usefulness of the Wavelia system is assessed in the clinical setting.

Feasibility of Portable Microwave Imaging Device for Breast Cancer Detection

“…A total of 92% of patients say they recommend this test method. The inspection time is as long as 50 min [ 20 , 21 , 22 ]. A Quadratic Discriminant Analysis (QDA) classifier was trained in a 3D feature space to discriminate malignant from benign lesions.…”

Pathway to Demonstrating Clinical Efficacy of Microwave Breast Imaging: Qualitative and Quantitative Performance Assessment

“…For specificity, it was found in [1] that the specificity (true negative rate) for the Mammowave system was approximately 62% ( 32 /52 correctly identified as negative). Additionally, in [51], the results from the same Wavelia clinical study as [7] were further analyzed using Quadratic Discriminant Analysis (QDA) to differentiate benign and malignant lesions. Accurate discrimination was achieved in 88.5% cases, and accurate lesion size estimate in 76.5% of cases.…”

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

“…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].…”

“…During the FiH clinical investigation, the Wavelia MBI system showed promise for measuring lesion size with a more favorable linear trend between MBI and postsurgery histological lesion size, compared to the results obtained for conventional imaging [14]. Two challenging patient cases in terms of breast lesion sizing are indicatively discussed in Results Section 3.2, to better highlight the status of the MBI lesion sizing method, as integrated into the current version of the Wavelia QIF.…”