Abstract PO5-19-11: A novel portable breast cancer screening method - initial institutional experience

Abstract Background: Breast ultrasound (US) is a remarkable supplementary tool alongside mammography and magnetic resonance imaging (MRI) for the detection of breast lesions. US imaging is a fast, reliable method to identify and localize breast pathology. Innovative technologies that aim to timely identification and prompt diagnosis of suspicious lesions in breast cancer screening remain a clinical need. ATUSA is a B-type rechargeable US, shaped as a wearable device. It uses a linear array of transducers with water acting as a coupling medium that recreates a 3-dimensional image of the scanned breast. The ATUSA portability makes this device a practical breast screening method during a healthcare office visit. We report the initial feasibility of ATUSA to detect breast lesions in an outpatient setting from a trial in progress. Methodology: Interim prospective data from 35 female patients presenting with a mass of equal or greater than 1 cm in size, with a baseline handheld US image and pathology reports that evidenced a cancer diagnosis or a lesion suspicious of malignancy. Breast cancer types included invasive ductal carcinoma (IDC), ductal carcinoma in situ (DCIS) and invasive lobular carcinoma (ILC), invasive mammary carcinoma (IMC) with mixed ductal and lobular features and atypical lobular hyperplasia (ALH). ATUSA and baseline handheld reference US images were cross-referenced from June 2022 to June 2023. Basic demographics, clinical characteristics, mammogram and/or MRI, and pathology reports were included in the analysis. Patients were followed up for a 30-day period to note occurrence of any adverse event (AE). Institutional Review Board (IRB) approved this study (protocol H-42616). Results: The 35 patients had a mean age of 57 years (range: 25 – 79), mean BMI 29.6 kg/m2 (range: 18.1 – 49.3). Mammographic breast density was fibroglandular tissue 15 (42.8%), followed by heterogeneously dense (HD) 13 (3.7%), mixed HD and fibroglandular 1 (2.8%), mildly dense 1 (2.8%), extremely dense 2 (5.7%), and extremely fatty 1 (2.8%). Breast sizes were 1 (2.8 %) A cup, 11 (31.4%) B cups, 1 (2.8%) B – C cups, 5 (14.2%) C cups, 1 (2.8%) C – D cups, 13 (37.1%) D cups, and 3 (8.5%) DD cups. The 35 scanned lesions had a diagnosis (compared with final resected pathology) classified as IDC 18 (51.4 %), DCIS 2 (5.7 %), mixed IDC and DCIS 6 (17.1 %), ILC 3 (8.5 %), IMC with mixed features 2 (5.7 %), IMC with DCIS 1 (2.8 %), ALH 1 (2.8 %), and 2 (5.7 %) benign masses. ATUSA successfully identified 17/35 (48.5 %) lesions from this group as malignant, from which 4 were hard to distinguish due to shadowing artifact and 3 were underestimated in size. A total of 15 (42.8 %) malignant lesions were missed by ATUSA. No AEs related to the ATUSA device were reported. Conclusion: The ATUSA provides the means to produce a good quality US image during a clinic visit or where a facility lacks conventional US imaging. When compared to the handheld US, ATUSA can be safely used in the outpatient setting without the need of trained specialists but requires further development and testing to match conventional breast imaging. Table 1. Basic clinical characteristics 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-19-11.