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01.04.2015 | Gynecologic Oncology

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

verfasst von: 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

Erschienen in: Archives of Gynecology and Obstetrics | Ausgabe 4/2015

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Abstract

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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Titel: Evaluation of an automated breast 3D-ultrasound system by comparing it with hand-held ultrasound (HHUS) and mammography
verfasst von: 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
Publikationsdatum: 01.04.2015
Verlag: Springer Berlin Heidelberg
Erschienen in: Archives of Gynecology and Obstetrics / Ausgabe 4/2015
Print ISSN: 0932-0067
Elektronische ISSN: 1432-0711
DOI: https://doi.org/10.1007/s00404-014-3509-9

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