title: Evaluation of an automated breast 3D-ultrasound system by comparing it with hand-held ultrasound (HHUS) and mammography.
abstract: OBJECTIVE
  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%).
  
  
  CONCLUSIONS
  The results of this study let us suggest, that automated 3D-US might be a helpful new tool in breast imaging, especially in screening.
authors.affiliation: University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany, michael.golatta@med.uni-heidelberg.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Golatta
authors.forename: Christina
authors.initials: C
authors.lastname: Baggs
authors.forename: Mirjam
authors.initials: M
authors.lastname: Schweitzer-Martin
authors.forename: Christoph
authors.initials: C
authors.lastname: Domschke
authors.forename: Sarah
authors.initials: S
authors.lastname: Schott
authors.forename: Aba
authors.initials: A
authors.lastname: Harcos
authors.forename: Alexander
authors.initials: A
authors.lastname: Scharf
authors.forename: Hans
authors.initials: H
authors.lastname: Junkermann
authors.forename: Geraldine
authors.initials: G
authors.lastname: Rauch
authors.forename: Joachim
authors.initials: J
authors.lastname: Rom
authors.forename: Christof
authors.initials: C
authors.lastname: Sohn
authors.forename: Joerg
authors.initials: J
authors.lastname: Heil
mesh_terms: D000328:Adult; D000368:Aged; D001940:Breast / Q000473:pathology*; D005260:Female; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D008327:Mammography; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D016217:Ultrasonography, Mammary / Q000295:instrumentation / Q000379:methods*