ShearWave™ Elastography BE1 multinational breast study: additional SWE™ features support potential to downgrade...

Area of Science:

• Medical Imaging
• Diagnostic Ultrasound
• Breast Imaging

Background:

• BI-RADS® 3 lesions are considered probably benign, requiring follow-up or biopsy.
• Accurate characterization of BI-RADS® 3 lesions is crucial to avoid unnecessary invasive procedures.
• ShearWave™ Elastography (SWE™) offers quantitative stiffness assessment, potentially improving lesion characterization.

Purpose of the Study:

• To evaluate the utility of ShearWave™ Elastography (SWE™) in differentiating benign from malignant BI-RADS® 3 breast lesions.
• To determine if SWE™ features can safely downgrade a subset of BI-RADS® 3 lesions.
• To assess the impact of SWE™-guided downgrading on malignancy rates within the BI-RADS® 3 category.

Main Methods:

• Analysis of 303 BI-RADS® 3 lesions from the prospective BE1 study.
• Inclusion of lesions with cytology/biopsy (n=201) or minimum one-year follow-up (n=102).
• Evaluation of seven SWE features for their ability to reclassify benign masses, focusing on E-color and E-max (kPa and m/s).

Main Results:

• An E-color of "black to dark blue" allowed downgrading of 110/303 lesions (p < 0.0001), with a non-significant malignancy rate increase from 2.6% to 4.1%.
• E-max ≤ 20 kPa (2.6 m/s) downgraded 48/303 lesions (p < 0.0001), resulting in a lower malignancy rate increase to 3.1%.
• No other SWE features demonstrated utility in reclassifying benign BI-RADS® 3 lesions.

Conclusions:

• ShearWave™ Elastography (SWE™), particularly using E-color and E-max stiffness values, can facilitate the downgrading of a subgroup of benign BI-RADS® 3 breast lesions.
• Implementing SWE™-based reclassification rules can potentially reduce unnecessary biopsies for benign lesions.
• The study observed a non-significant increase in the malignancy rate within the newly defined BI-RADS® 3 category after applying SWE™ downgrading criteria.