title: ShearWave™ Elastography BE1 multinational breast study: additional SWE™ features support potential to downgrade BI-RADS®-3 lesions.
abstract: OBJECTIVE
  To determine the benefit of ShearWave™ Elastography (SWE™) in the ultrasound characterization of BI-RADS® 3 breast lesions in a diagnostic population.
  
  
  METHODS
  303 BI-RADS® 3 lesions (mean size: 13.2 mm, SD: 7.5 mm) from the multicenter BE1 prospective study population were analyzed: 201 (66%) had cytology or core biopsy, and the remaining 102 had a minimum follow-up of one year; 8 (2.6%) were malignant. 7 SWE features were evaluated with regard to their ability to downgrade benign BI-RADS® 3 masses. The performance of each SWE feature was assessed by evaluating the number of lesions correctly reclassified and the impact on cancer rates within the new BI-RADS® 3' lesion group.
  
  
  RESULTS
  No malignancies were found with an E-color "black to dark blue", which allowed the downgrading of 110/303 benign masses (p < 0.0001), with a non-significant increase in BI-RADS® 3' malignancy rate from 2.6% to 4.1%. E-max ≤ 20 kPa (2.6 m/s) was able to downgrade 48/303 (p < 0.0001) lesions with a lower increase in BI-RADS® 3' malignancy rate (3.1%). No other SWE features were useful for reclassifying benign BI-RADS® 3 lesions.
  
  
  CONCLUSIONS
  Applying simple reclassification rules, SWE assessment of the maximum stiffness of lesions allowed the downgrading of a sub-group of benign BI-RADS® 3 lesions. This was accompanied by a non-significant increase in the malignancy rate in the new BI-RADS® 3 class.
authors.affiliation: Breast center, University Hospital Schleswig-Holstein, Kiel.
authors.forename: F K W
authors.initials: FK
authors.lastname: Schäfer
authors.forename: R J
authors.initials: RJ
authors.lastname: Hooley
authors.forename: R
authors.initials: R
authors.lastname: Ohlinger
authors.forename: U
authors.initials: U
authors.lastname: Hahne
authors.forename: H
authors.initials: H
authors.lastname: Madjar
authors.forename: W E
authors.initials: WE
authors.lastname: Svensson
authors.forename: C
authors.initials: C
authors.lastname: Balu-Maestro
authors.forename: V
authors.initials: V
authors.lastname: Juhan
authors.forename: A
authors.initials: A
authors.lastname: Athanasiou
authors.forename: A
authors.initials: A
authors.lastname: Mundinger
authors.forename: B
authors.initials: B
authors.lastname: Order
authors.forename: M
authors.initials: M
authors.lastname: Locatelli
authors.forename: D
authors.initials: D
authors.lastname: Cosgrove
authors.forename: O J
authors.initials: OJ
authors.lastname: Wolf
authors.forename: J P
authors.initials: JP
authors.lastname: Henry
authors.forename: M
authors.initials: M
authors.lastname: Moutfi
authors.forename: J M
authors.initials: JM
authors.lastname: Gay
authors.forename: C
authors.initials: C
authors.lastname: Cohen-Bacrie
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000145:classification / Q000000981:diagnostic imaging* / Q000473:pathology*; D054459:Elasticity Imaging Techniques / Q000295:instrumentation* / Q000379:methods*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D007090:Image Interpretation, Computer-Assisted / Q000379:methods*; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D012306:Risk; D012680:Sensitivity and Specificity; D016217:Ultrasonography, Mammary / Q000295:instrumentation* / Q000379:methods*; D055815:Young Adult