The Potential of Shear Wave Elastography to Reduce Unnecessary Biopsies in Breast Cancer Diagnosis: An International, Diagnostic, Multicenter Trial

Abstract

Purpose In this prospective, multicenter trial we evaluated whether additional shear wave elastography (SWE) for patients with BI-RADS 3 or 4 lesions on breast ultrasound could further refine the assessment with B-mode breast ultrasound for breast cancer diagnosis.

Materials and Methods We analyzed prospective, multicenter, international data from 1288 women with breast lesions rated by conventional 2 D B-mode ultrasound as BI-RADS 3 to 4c and undergoing 2D-SWE. After reclassification with SWE the proportion of undetected malignancies should be < 2 %. All patients underwent histopathologic evaluation (reference standard).

Results Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6 %). The assessment with B-mode breast ultrasound resulted in 1.39 % (6 of 431) undetected malignancies (malignant lesions in BI-RADS 3) and 53.80 % (495 of 920) unnecessary biopsies (biopsies in benign lesions). Re-classifying BI-RADS 4a patients with a SWE cutoff of 2.55 m/s resulted in 1.98 % (11 of 556) undetected malignancies and a reduction of 24.24 % (375 vs. 495) of unnecessary biopsies.

Conclusion A SWE value below 2.55 m/s for BI-RADS 4a lesions could be used to downstage these lesions to follow-up, and therefore reduce the number of unnecessary biopsies by 24.24 %. However, this would come at the expense of some additionally missed cancers compared to B-mode breast ultrasound (rate of undetected malignancies 1.98 %, 11 of 556, versus 1.39 %, 6 of 431) which would, however, still be in line with the ACR BI-RADS 3 definition (< 2 % of undetected malignancies).

Zusammenfassung

Ziele In dieser prospektiven, multizentrischen Studie wurde untersucht, ob die zusätzliche Verwendung von Scherwellen-Elastografie (SWE) für Patientinnen mit BI-RADS-3- oder -4-Läsionen die Untersuchung mit B-Mode-Brustultraschall weiter verbessern kann.

Methoden Wir analysierten Daten von 1288 Frauen mit Brustläsionen, die im konventionellen 2D-B-Mode-Ultraschall als BI-RADS 3 bis 4c eingestuft wurden und zusätzlich mittels 2D-SWE untersucht wurden. Nach Rekategorisierung mittels SWE sollte der Anteil an unerkannten Karzinomen < 2 % sein.

Ergebnisse 368 der 1288 Läsionen (28,6 %) zeigten ein Karzinom. Die Untersuchung mit B-Mode-Brustultraschall resultierte in 1,39 % (6 von 431) unerkannten Karzinomen (maligne Läsionen in BI-RADS 3) und 53,80 % (495 von 920) unnötigen Biopsien (Biopsien in benignen Läsionen). Die Rekategorisierung von BI-RADS-4a-Läsionen mit einem SWE-Cut-off von 2,55 m/s resultierte in 1,98 % (11 von 556) unerkannten Karzinomen und einer Reduktion von 24,24 % (375 vs. 495) unnötiger Biopsien.

Schlussfolgerung Ein SWE-Wert von unter 2,55 m/s für BI-RADS-4a-Läsionen könnte verwendet werden, um diese Läsionen zu einer Follow-up-Untersuchung herabzustufen und somit die Anzahl minimalinvasiver Biopsien um etwa 24,24 % zu reduzieren. Allerdings würde dies auf Kosten einiger zusätzlich verpasster Karzinome im Vergleich zur Untersuchung mit B-Mode-Brustultraschall erfolgen (Rate an unerkannten Karzinomen 1,98 %, 11 von 556, versus 1,39 %, 6 von 431), was jedoch weiterhin im Rahmen der ACR-BI-RADS-3-Definition liegen würde (< 2 % unerkannte Karzinome).

Key words

breast ultrasound - BI-RADS - suspicious breast lesion - shear wave elastography

Publikationsverlauf

Eingereicht: 17. November 2020

Angenommen: 28. Juni 2021

Artikel online veröffentlicht:
23. August 2021

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