Abstract
BackgroundAutomated whole breast ultrasound scanners of the latest generation have reached a level of comfortable application and high quality volume acquisition. Nevertheless, there is a lack of data concerning this technology. We investigated the diagnostic performance and inter-observer concordance of the Automated Breast Volume Scanner (ABVS) ACUSON S2000™ and questioned its implications in breast cancer diagnostics.MethodsWe collected 100 volume data sets and created a database containing 52 scans with no detectable lesions in conventional ultrasound (BI-RADS®-US 1), 30 scans with benign lesions (BI-RADS®-US 2) and 18 scans with breast cancer (BI-RADS®-US 5).Two independent examiners evaluated the ABVS data on a separate workstation without any prior knowledge of the patients’ histories.ResultsThe inter-rater reliability reached fair agreement (κ=0.36; 95% confidence interval (CI): 0.19-0.53). With respect to the true category, the conditional inter-rater validity coefficient was κ=0.18 (95% CI: 0.00-0.26) for the benign cases and κ=0.80 (95% CI: 0.61-1.00) for the malignant cases.Combining the assessments of examiner 1 and examiner 2, the diagnostic accuracy (AC), sensitivity (SE) and specificity (SP) for the experimental ABVS were AC = 79.0% (95% CI: 67.3-86.1), SE = 83.3% (95% CI: 57.7-95.6) and SP = 78.1% (% CI: 67.3-86.1), respectively.However, after the ABVS examination, there were a high number of requests for second-look ultrasounds in up to 48.8% of the healthy women due to assumed suspicious findings in the volume data.In an exploratory analysis, we estimated that an ABVS examination in addition to mammography alone could detect a relevant number of previously occult breast cancers (about 1 cancer in 300 screened and otherwise healthy women).ConclusionsThe ABVS is a reliable imaging method for the evaluation of the breast with high sensitivity and a fair inter-observer concordance. However, we have to overcome the problem of the high number of false-positive results. Therefore, further prospective studies in larger collectives are necessary to define standard procedures in image acquisition and interpretation. Nevertheless, we consider the ABVS as being suitable for integration into breast diagnostics as a beneficial and reliable imaging method.
Highlights
Automated whole breast ultrasound scanners of the latest generation have reached a level of comfortable application and high quality volume acquisition
We present data concerning an up-to-date technology in automated ultrasound, the Automated Breast Volume Scanner (ACUSON S2000TM ABVS; Siemens Medical Solutions, Inc., CA, USA)
All BI-RADS®-US 5 lesions were confirmed with histological specimens
Summary
Automated whole breast ultrasound scanners of the latest generation have reached a level of comfortable application and high quality volume acquisition. While the incidence of breast cancer remains considerably high, we notice a relevant decline in cancer mortality in numerous countries. This effort can partly be explained by new and innovative therapies, but there is sound evidence that advances in early detection probably play the most decisive role [4]. The early detection of breast cancer has moved into the central focus of primary healthcare. This success could only be achieved because of improvements in imaging technologies and a higher degree of health awareness
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