Evaluation of an automated breast 3D-ultrasound system by comparing it with hand-held ultrasound (HHUS) and mammography

Purpose: Automated three-dimensional (3D) breast ultrasound (US) systems are meant to overcome the shortcomings of hand-held ultrasound (HHUS). The aim of this study is to analyze and compare clinical performance of an automated 3D-US system by comparing it with HHUS, mammography and the clinical go...

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Main Authors: Golatta, Michael (Author) , Baggs, Christina (Author) , Schweitzer-Martin, Mirjam (Author) , Domschke, Christoph (Author) , Schott, Sarah (Author) , Harcos, Aba (Author) , Scharf, Alexander (Author) , Junkermann, Hans (Author) , Rauch, Geraldine (Author) , Rom, Joachim (Author) , Sohn, Christof (Author) , Heil, Jörg (Author)
Format: Article (Journal)
Language:English
Published: 2015
In: Archives of gynecology and obstetrics
Year: 2015, Volume: 291, Issue: 4, Pages: 889-895
ISSN:1432-0711
DOI:10.1007/s00404-014-3509-9
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1007/s00404-014-3509-9
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Author Notes:Michael Golatta, Christina Baggs, Mirjam Schweitzer-Martin, Christoph Domschke, Sarah Schott, Aba Harcos, Alexander Scharf, Hans Junkermann, Geraldine Rauch, Joachim Rom, Christof Sohn, Joerg Heil

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245 1 0 |a Evaluation of an automated breast 3D-ultrasound system by comparing it with hand-held ultrasound (HHUS) and mammography  |c Michael Golatta, Christina Baggs, Mirjam Schweitzer-Martin, Christoph Domschke, Sarah Schott, Aba Harcos, Alexander Scharf, Hans Junkermann, Geraldine Rauch, Joachim Rom, Christof Sohn, Joerg Heil 
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520 |a Purpose: Automated three-dimensional (3D) breast ultrasound (US) systems are meant to overcome the shortcomings of hand-held ultrasound (HHUS). The aim of this study is to analyze and compare clinical performance of an automated 3D-US system by comparing it with HHUS, mammography and the clinical gold standard (defined as the combination of HHUS, mammography and—if indicated—histology). Methods: Nine hundred and eighty three patients (=1,966 breasts) were enrolled in this monocentric, explorative and prospective cohort study. All examinations were analyzed blinded to the patients´ history and to the results of the routine imaging. The agreement of automated 3D-US with HHUS, mammography and the gold standard was assessed with kappa statistics. Sensitivity, specificity and positive and negative predictive value were calculated to assess the test performance. Results: Blinded to the results of the gold standard the agreement between automated 3D-US and HHUS or mammography was fair, given by a Kappa coefficient of 0.31 (95 % CI [0.26;0.36], p\0.0001) and 0.25 (95 % CI [0.2;0.3], p\ 0.0001), respectively. Our results showed a high negative predictive value (NPV) of 98 %, a high specificity of 85 % and a sensitivity of 74 % based on the cases with US-guided biopsy. Including the cases where the lesion was seen in a second-look automated 3D-US the sensitivity improved to 84 % (NPV = 99 %, specificity = 85 %). Conclusion: The results of this study let us suggest, that automated 3D-US might be a helpful new tool in breast imaging, especially in screening. 
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