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

F. K. W. Schäfer; R. J. Hooley; R. Ohlinger; U. Hahne; H. Madjar; W. E. Svensson; C. Balu-Maestro; V. Juhan; A. Athanasiou; A. Mundinger; B. Order; M. Locatelli; D. Cosgrove; O. J. Wolf; J. P. Henry; M. Moutfi; J. M. Gay; C. Cohen-Bacrie

doi:10.1055/s-0033-1335523

Ultraschall in der Medizin - European Journal of Ultrasound, Table of Contents

Ultraschall Med 2013; 34(3): 254-259
DOI: 10.1055/s-0033-1335523

Original Article

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

¹Breast center, University Hospital Schleswig-Holstein, Kiel

,

R. J. Hooley

²Medical Center, Yale University School of Medicine, New Haven

,

R. Ohlinger

³Department of Gynecology and Obstetrics, Ernst-Moritz-Arndt University Greifswald

,

U. Hahne

³Department of Gynecology and Obstetrics, Ernst-Moritz-Arndt University Greifswald

,

H. Madjar

⁴Gynecology, DKD, Wiesbaden

,

W. E. Svensson

⁵Breast Imaging, Imperial College Healthcare NHT Trust, Charing Cross Hospital, London

,

C. Balu-Maestro

⁶Breast Imaging, Centre Antoine Lacassagne, Nice

,

V. Juhan

⁷Breast imaging, University Hospital La Timone, Marseille

,

A. Athanasiou

⁸Radiology, Institut Curie, Paris

,

A. Mundinger

⁹Breast Center, Marienhospital, Osnabrück

,

B. Order

¹Breast center, University Hospital Schleswig-Holstein, Kiel

,

M. Locatelli

¹⁰Breast imaging, Ospedale Civile di Gorizia

,

D. Cosgrove

¹¹Imaging Sciences Department, Imperial College, Hammersmith Hospital, London

,

O. J. Wolf

¹²Diagnostische Radiologie, Gesellschafter RadiologieWitten

,

J. P. Henry

¹³Product Management, SuperSonic Imagine, Aix-en-Provence

,

M. Moutfi

¹⁴Statistics, University of Poitiers

,

J. M. Gay

¹⁵Education, SuperSonic Imagine, Aix-en-Provence Cedex

,

C. Cohen-Bacrie

¹⁶Management, SuperSonic Imagine, Aix-en-Provence

› Author Affiliations

Abstract

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.

Zusammenfassung

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.

Key words

breast - ultrasound - diagnostic radiology - tumor

Full Text

References

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