ShearWave Elastography increases performance of ultrasound breast cancer diagnosis

SuperSonic Imagine presented yesterday the validation of a world wide multicentre study, based on European recruitment, confirming the benefit of ShearWave Elastography when added to ultrasound for improved lesion classification.

Launched by SuperSonic Imagine in June 2008, the global, multi-centre study was conducted across 16 American and European sites involving 1,800 patients with breast lesions.

The first major result of this study demonstrated that ShearWave Elastography is reproducible both quantitatively and qualitatively. This reproducible technology provides strong assurance of precise tissue evaluation during diagnosis and is expected to be also useful in follow-up.

The second important outcome is a statistical model based on 939 lesions, which showed that ShearWave Elastography increases the performance of ultrasound breast cancer diagnosis. The addition of ShearWave Elastography features, such as maximum elasticity (stiffness) or heterogeneity (uniformity) of a lesion, to B-mode ultrasound, would permit an improvement in the BI-RADS^® classification accuracy, (standardization tool for breast lesion classification from the American College of Radiology) improving breast diagnosis.

European results validate the conclusions of the model

In Europe, 1,223 lesions have been examined, including 425 cancers (34.8%). The European study was conducted across four sites in France (332 lesions), four sites in Germany (585 lesions), one site in Italy (104 lesions) and one site in United-Kingdom (202 lesions).

The application of the model to this sub-group demonstrates the importance of the maximum elasticity value. When added to the BI-RADS^® score, this value:

• Maintains the sensitivity of the ultrasound exam (97.9%)
• Increases its specificity by more than 8 per cent (59.9% to 68.2%)
• Maintains its negative predictive value above 98%
• Increases its positive predictive value by more than 5 per cent (73.1% to 78.5%)

These results confirm the increase in specificity expected with the addition of ShearWave Elastography features to BI-RADS^® criteria and consequently the reduction of the rate of negative biopsies. In addition, ShearWave Elastography can assist in diagnosing cancers that would have otherwise fallen into a follow-up category, thus earlier intervention and treatment could occur with significant implications for patient management.