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Purpose: This study aimed to evaluate the dependability of automated breast ultrasound (ABUS) compared with handheld ultrasound (HHUS) and mammography (MG) on the Breast Imaging Reporting and Data System (BI-RADS) category and size assessment of malignant breast lesions. Patients and Methods: A total of 344 confirmed malignant lesions were recruited. All participants underwent MG, HHUS, and ABUS examinations. Agreements on the BI-RADS category were evaluated. Lesion size assessed using the three methods was compared with the size of the pathological result as the control. Regarding the four major molecular subtypes, correlation coefficients between size on imaging and pathology were also evaluated. Results: The agreement between ABUS and HHUS on the BI-RADS category was 86.63% (kappa = 0.77), whereas it was 32.22% (kappa = 0.10) between ABUS and MG. Imaging lesion size compared to pathologic lesion size was assessed correctly in 36.92%/52.91% (ABUS), 33.14%/48.84% (HHUS) and 33.44%/43.87% (MG), with the threshold of 3 mm/5 mm, respectively. The correlation coefficient of size of ABUS-Pathology (0.75, Spearman) was statistically higher than that of the MG-Pathology (0.58, Spearman) with P < 0.01, but not different from that of the HHUS-Pathology (0.74, Spearman) with P > 0.05. The correlation coefficient of ABUS-Pathology was statistically higher than that of MG-Pathology in the triple-negative subtype, luminal B subtype, and luminal A subtype (P< 0.01). Conclusion: The agreement between ABUS and HHUS in the BI-RADS category was good, whereas that between ABUS and MG was poor. ABUS and HHUS allowed a more accurate assessment of malignant tumor size compared to MG. [ABSTRACT FROM AUTHOR]

To explore the value of hand-held ultrasound (HHUS) for diagnosing complex cystic and solid breast lesions, 472 pathologically proven lesions were analyzed. The lesions were divided into four types based on ultrasound features. Positive predictive values (PPVs) for lesion types and risk factor performances were assessed. Furthermore, HHUS and mammography (MAM) performances were compared: 27 lesions missed in MAM were detected in HHUS. Ultrasound feature analysis revealed higher PPVs for type III and IV lesions than for type I and II lesions. In patients older than 51 y, a type III or IV lesion with a diameter greater than 18 mm, an irregular shape, a non-parallel orientation, an uncircumscribed margin, calcification, vascularity and abnormal axillary lymph nodes were suggestive of malignancy; the area under the curve reached 0.869. Thus, ultrasound is useful in diagnosing complex cystic and solid breast lesions, which should be categorized as Breast Imaging Reporting and Data System (BI-RADS) 4B or 4C. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to assess the reliability of automated breast ultrasound (ABUS) examinations of suspicious breast masses in comparison to handheld breast ultrasound (HHUS) with regard to Breast Imaging Reporting and Data System (BI-RADS) category assessment, and to investigate the factors affecting discrepancies in categorization. Methods: A total of 135 masses that were assessed as BI-RADS categories 4 and 5 on ABUS that underwent ultrasound (US)-guided core needle biopsy from May 2017 to December 2017 were included in this study. The BI-RADS categories were re-assessed using HHUS. Agreement of the BI-RADS categories was evaluated using kappa statistics, and the positive predictive value of each examination was calculated. Logistic regression analysis was performed to identify the mammography and US findings associated with discrepancies in the BI-RADS categorization. Results: The overall agreement between ABUS and HHUS in all cases was good (79.3%, kappa=0.61, P<0.001). Logistic regression analysis revealed that accompanying suspicious microcalcifications on mammography (odds ratio [OR], 4.63; 95% confidence interval [CI], 1.83 to 11.71; P=0.001) and an irregular shape on US (OR, 5.59; 95% CI, 1.43 to 21.83; P=0.013) were associated with discrepancies in the BI-RADS categorization. Conclusion: The agreement between ABUS and HHUS examinations in the BI-RADS categorization of suspicious breast masses was good. The presence of suspicious microcalcifications on mammography and an irregular shape on US were factors associated with ABUS yielding a lower level of suspicion than HHUS in terms of the BI-RADS category assessment. [ABSTRACT FROM AUTHOR]

Purpose: Breast ultrasound could be a valuable tool complementary to mammography in breast cancer screening. Automated 3D breast ultrasound (ABUS) addresses challenges of hand-held ultrasound and could allow double reading analysis of ultrasound images. This trial assesses the inter-rater reliability and double reading analysis of an ABUS system.Methods: To assess the reproducibility and diagnostic validity of the ABUS system, SomoV™, a blinded double reading analysis, was performed in 1019 patients (2038 breasts) by two examiners (examiner A/B) and compared to single reading results, as well as to the reference standard regarding its diagnostic validity. Cohen's kappa coefficients were calculated to measure the inter-rater reliability and agreement of the different diagnostic modalities. Patient comfort and time consumption for image acquisition and reading were analyzed descriptively as secondary objectives.Results: Analysis of inter-rater reliability yielded agreement in 81.6% (κ = 0.37; p < 0.0001) showing fair agreement. Single reading analysis of SomoV™ exams (examiner A/examiner B) compared to reference standard showed good specificity (examiner A: 88.3%/examiner B: 84.5%), fair inter-rater agreement (examiner A: κ = 0.31/examiner B: κ = 0.31), and adequate sensitivity (examiner A: 53.1%/examiner B: 64.2%). Double reading analysis yielded good sensitivity and specificity (73.7 and 77.7%). Mammography (n = 1911) alone detected 160 of 176 carcinomas (sensitivity 90.1%). Adding SomoV™ to mammography would have detected 12 additional carcinomas, resulting in a higher sensitivity of 97.7%.Conclusion: SomoV™ is a promising technique with good sensitivity, high patient comfort, and fair inter-examiner reliability. It allows double reading analysis that, in combination with mammography, could increase detection rates in breast cancer screening. [ABSTRACT FROM AUTHOR]