Ultraschall Med 2013; 34(3): 254-259
DOI: 10.1055/s-0033-1335523
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

ShearWave™ Elastography BE1 Multinational Breast Study: Additional SWE™ Features Support Potential to Downgrade BI-RADS®-3 Lesions

Scherwellen-Elastografie: BE 1 internationale Multicenter Studie – Zusätzliche Scherwellen-Elastografie Kriterien unterstützen ein mögliches Downgrading von BI-RADS® 3 Läsionen
F. K. W. Schäfer
1   Breast center, University Hospital Schleswig-Holstein, Kiel
R. J. Hooley
2   Medical Center, Yale University School of Medicine, New Haven
R. Ohlinger
3   Department of Gynecology and Obstetrics, Ernst-Moritz-Arndt University Greifswald
U. Hahne
3   Department of Gynecology and Obstetrics, Ernst-Moritz-Arndt University Greifswald
H. Madjar
4   Gynecology, DKD, Wiesbaden
W. E. Svensson
5   Breast Imaging, Imperial College Healthcare NHT Trust, Charing Cross Hospital, London
C. Balu-Maestro
6   Breast Imaging, Centre Antoine Lacassagne, Nice
V. Juhan
7   Breast imaging, University Hospital La Timone, Marseille
A. Athanasiou
8   Radiology, Institut Curie, Paris
A. Mundinger
9   Breast Center, Marienhospital, Osnabrück
B. Order
1   Breast center, University Hospital Schleswig-Holstein, Kiel
M. Locatelli
10   Breast imaging, Ospedale Civile di Gorizia
D. Cosgrove
11   Imaging Sciences Department, Imperial College, Hammersmith Hospital, London
O. J. Wolf
12   Diagnostische Radiologie, Gesellschafter RadiologieWitten
J. P. Henry
13   Product Management, SuperSonic Imagine, Aix-en-Provence
M. Moutfi
14   Statistics, University of Poitiers
J. M. Gay
15   Education, SuperSonic Imagine, Aix-en-Provence Cedex
C. Cohen-Bacrie
16   Management, SuperSonic Imagine, Aix-en-Provence
› Author Affiliations
Further Information

Publication History

05 July 2012

09 April 2013

Publication Date:
24 May 2013 (online)


Purpose: To determine the benefit of ShearWave™ Elastography (SWE™) in the ultrasound characterization of BI-RADS® 3 breast lesions in a diagnostic population.

Materials and 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 ≤ 20kPa (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.

Conclusion: 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.


Ziel: Evaluation der Scherwellen-Elastografie (SWE) zur näheren Charakterisierung von BI-RADS®-3 Läsionen in der Mamma.

Material und Methoden: Insgesamt wurden 303 BI-RADS®-3 Läsionen (Durchschnitt der Größe: 13,2 mm, Standardabweichung: 7,5 mm) aus dem Studienkollektiv der prospektiven BE1 Multicenter-Studie analysiert. 201/303 (66 %) Läsionen wurden minimalinvasiv zytologisch oder histologisch abgeklärt, bei 102/303 (33 %) lag ein Follow-up von mind. 1 Jahr vor. 8/303 (2,6 %) Läsionen waren maligne. Sieben verschiedene SWE-Kriterien wurden hinsichtlich ihres Einflusses auf eine korrekte Reklassifikation von BI-RADS®-3 Läsionen und eine mögliche Herabstufung auf eine neue Klassifikation BI-RADS®-3’ untersucht.

Ergebnisse: Keine malignen Befunde ergaben sich für das Kriterium Elastografie-Farbe (E color) „schwarz bis dunkelblau“, was ein Downgrading von 110/303 Läsionen erlaubte (p < 0,0001); nicht signifikanter Anstieg der Malignitätsrate in der neuen BI-RADS-3®’ Klassifikation von 2,6 % auf 4,1 %. Mit dem Zusatzkriterium maximale Elastizität (E Max) ≤ 20kPa (2,6 m/s) konnten 48/303 Läsionen reklassifiziert werden (p < 0,0001); geringerer nicht signifikanter Malignitätsanstieg von 2,6 % auf 3,1 %. Die übrigen SWE-Kriterien waren nicht geeignet für eine Reklassifikation der BI-RADS®-3 Läsionen.

Schlussfolgerungen: Die Anwendung einfacher Reklassifikationsregeln wie der maximalen Elastizität erlauben ein sicheres Downgrading von BI-RADS®-3 Läsionen in eine neue BI-RADS®-3’ Untergruppe, ohne das es zu einem signifikanten Malignitätsanstieg kommt.

  • References

  • 1 Stavros AT, Thickman D, Rapp CL et al. Solid breast nodules: use of sonography to distinguish between benign and malignant lesions. Radiology 1995 ; 196: 123-34
  • 2 Mendelson EB, Baum JK, Berg WA et al. Breast Imaging Reporting and Data System, BI-RADS®: Ultrasound. 1st Ed. Reston: American College of Radiology; 2003
  • 3 Bamber J, Cosgrove D, Dietrich CF et al. EFSUMB Guidelines and Recommendations on the Clinical Use of Ultrasound Elastography. Part 1: Basic Principles and Technology. Ultraschall in Med 2013; 34: 169-184
  • 4 Cosgrove D, Piscaglia F, Bamber J et al. EFSUMB Guidelines and Recommendations on the Clinical Use of Ultrasound Elastography. Part 2: Clinical Applications. Ultraschall in Med 2013; DOI: 10.1055/s-0033-1335375.
  • 5 Garra BS, Cespedes EI, Ophir J et al. Elastography of breast lesions: initial clinical results. Radiology 1997; 202: 79-86
  • 6 Bercoff J, Tanter M, Fink M. Supersonic shear imaging: a new technique for soft tissue elasticity mapping. IEEE Trans Ultrason Ferroelectr Freq Control 2004; 51: 396-409
  • 7 Cosgrove DO, Berg WA, Doré CJ et al. the BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol 2011; Epub ahead of print
  • 8 Berg W, Cosgrove D, Doré JC et al. Shearwave Elastography Improves the Specificity of Breast Ultrasound: The BE1 Multinational Study of 939 Masses. Radiology 2012; 262: 435-449
  • 9 Lazarus E, Mainiero MB, Schepps B et al. BI-RADS® lexicon for US and mammography:interobserver variability and positive predictive value. Radiology 2006; 239: 385-391
  • 10 Chiorean AR, Duma MM, Dudea SM et al. Typical and Unusual Sonoelastographic Patterns of Breast Cystic Lesions: Impact on BI-RADS Classification. Ultraschall in Med 2012; 33: E138-E144
  • 11 Ciurea AI, Bolboaca SD, Ciortea CA et al. The technical factors on sonoelastographic assessment of solid breast nodules. Ultraschall in Med 2011; 32: 27-34
  • 12 Scaperrotta G, Ferranti C, Costa C et al. Role of sono-elastography in non-palpable breast lesions. Eur Radiol 2008; 18: 2381-2389
  • 13 Ciurea AI, Bolboaca SD, Ciortea CA et al. The Influence of Technical Factors on Sonoelastographic Assessment of Solid Breast Nodules. Ultraschall in Med 2011; 32: 27-34
  • 14 Schaefer FKW, Heer I, Schaefer PJ et al. Breast ultrasound elastography – Results of 193 breast lesions in a prospective study with histopathologic correlation. Eur J Radiol 2011; 77: 450-456
  • 15 Isermann R, Grunwald S, Hatzung G et al. Breast lesion sizing by B-Mode Imaging and Sonoelastography in comparison to histopathological Sizing – a prospective study. Ultraschall in Med 2011; 32: 21-26
  • 16 Evans A, Whelehan P, Thomson K et al. Quantitative shear wave ultrasound elastography: initial experience in solid breast masses. Breast Cancer Res 2010; 12: R104
  • 17 Athanasiou A, Tardivon A, Tanter M et al. Breast lesions: Quantitative Elastography with Supersonic Shear Imaging – Preliminary results. Radiology 2010; 256: 297-303
  • 18 Itoh A, Ueno E, Tohno E et al. Breast disease: Clinical application of US elastography for diagnosis. Radiology 2006; 239: 341-350
  • 19 Adamietz BR, Meier-Meitinger M, Fasching P et al. New diagnostic criteria in Real-Time Elastography for the assessment of breast lesions. Ultraschall in Med 2011; 32: 67-73
  • 20 Wojcinski S, Farrokh A, Weber S et al. Multicenter study of ultrasound Real-Time tissue Elastography in 779 cases for assessment of breast lesions: Improved diagnostic performance by combining the BI-RADS®-US classification system with Sonoelastography. Ultraschall in Med 2011; 31: 484-491
  • 21 Hall TJ, Zhu Y, Spalding CS. In vivo real-time freehand palpation imaging. Ultrasound Med Biol 2003; 29: 427-435
  • 22 Hiltawsky KM, Kruger M, Starke C et al. Freehand ultrasound elastography of breast lesions: clinical results. Ultrasound Med Biol 2001; 27: 1461-1469
  • 23 Krouskop TA, Younes PS, Srinivasan S et al. Differences in the compressive stress-strain response of infiltrating ductal carcinomas with and without lobular features: implications for mammography and elastography. Ultrason Imaging 2003; 25: 162-170
  • 24 Fischer T, Peisker U, Fiedor S et al. Significant Differentiation of Focal Breast Lesions: Raw Data-Based Calculation of Strain Ratio. Ultraschall in Med 2012; 33: 357-365
  • 25 Adamietz BR, Kahmann L, Fasching PA et al. Differentiation Between Phyllodes Tumor and Fibroadenoma Using Real-Time Elastography. Ultraschall in Med 2011; 32: E75-E79
  • 26 Farrokh A, Wojcinski S, Degenhardt F et al. Diagnostische Aussagekraft der Strain-Ratio-Messung zur Unterscheidung zwischen malignen und benignen Brusttumoren. Ultraschall in Med 2011; 32: 400-405
  • 27 Fu CY, Hsu HH, Yu JC et al. Influence of Age on PPV of Sonographic BI-RADS Categories 3, 4, and 5. Ultraschall in Med 2011; 32: 8-13
  • 28 Graf O, Helbich TH, Hopf G et al. Probably benign breast masses at US:is follow-up an acceptable alternative to biopsy?. Radiology 2007; 244: 87-93
  • 29 Harvey JA, Nicholson BT, Lorusso AP et al. Short-term follow-up of palpable breast lesions with benign imaging features: evaluation of 375 lesions in 320 women. Am J Roentgenol 2009; 193: 1723-1730