SRS129 - Diagnostic performance of the second-generation wavelia microwave breast imaging system: a pilot clinical investigation

Abstract Background Microwave Breast Imaging (MWBI) represents a promising technology and is in the early investigative phase in the field of breast imaging. Wavelia MWBI system is a novel, non-ionising, non-compressive imaging device capable of 3D volumetric reconstruction and semi-automated lesion analysis. Aims To assess detectability and diagnostic performance of the Wavelia #2 MWBI system. Methods A single-centre, prospective pilot study was conducted. Patients presenting with symptomatic breast lesions underwent Wavelia #2 MWBI scanning in conjunction with standard of care work-up. Primary outcome was per-patient lesion detectability. Secondary outcomes included lesion sizing accuracy and subgroup analyses by breast density, age, and biopsy-clip status. Results 62 patients were included in total. Overall 56 out of 62 primary lesions were detected (sensitivity = 90.3%; 95% c.i. [80.45–95.49]), including 84.4% of malignant and 96.7% of benign lesions. The system demonstrated notably accurate sensitivity in dense breasts (BI-RADS C/D: 91.4% (32/35)) and smaller lesions of 10–15 mm size (100% (14/14)), and also displayed satisfactory performance in younger patients, detecting lesions in 95.5% of those under 40 years of age (21/22; 95% c.i. [78.20–99.19]) and 96.0% of pre-menopausal patients above 40 years of age (24/25; 95% c.i.: [80.46–99.29]). Overall, detection rates were comparable across subgroups regardless of age, breast density, or presence of biopsy clips. Conclusions The Wavelia #2 MWBI demonstrated robust lesion detectability, particularly in clinically challenging cohorts such as younger women and those with dense breasts. Further studies in broader cohorts are warranted to validate its utility in screening and diagnostic pathways.