SuperSonic said that the study has two objectives, the first is to demonstrate that images obtained using ShearWave Elastography are reproducible. The second is to compare ultrasound alone versus the combination of ultrasound and ShearWave Elastography for breast lesion diagnosis. The goal of the latter is to improve lesion classification in categories BI-RADS 3 and BI-RADS 4 in order to better direct patients towards clinical follow-up or biopsy.
ShearWave Elastography is a technology that gives additional information about tissue elasticity. It requires no manual compression and computes true tissue elasticity by measuring the velocity of shear waves as they propagate in tissue.
The company said that the clinical results clearly showed that ShearWave Elastography is reproducible both qualitatively and quantitatively. Reproducibility assures the physician of a reliable and precise evaluation of a lesion, both during an elastography examination and over time, which is key for follow up.
The results of the multicenter study show that ShearWave Elastography combined with ultrasound, further improves lesion classification by raising the percentage of lesions that are correctly classified and increases the specificity in the diagnosis while keeping a high negative predictive value and sensitivity.
The results of the clinical study, which are scientifically evaluated, therefore demonstrate that ShearWave Elastography features, when added to the Breast Imaging-Reporting and Data System (BI-RADS) score, improve the specificity and sensitivity of the diagnosis of the lesion. Associated with the BI-RADS score, the features increase the percentage of correctly classified lesions and improve lesion diagnosis, said the company.
Claude Cohen-Bacrie, co-founder and scientific director of SuperSonic Imagine, based in Aix-en-Provence, France, said: “This clinical investigation is the largest trial ever undertaken by an ultrasound imaging company as the recruitment will involve a targeted 2300 breast lesion cases.”
“Today it is essential to obtain additional information on breast lesions to improve diagnosis. In an era of healthcare reform, being able to reduce the number of biopsies by correctly classifying lesions could save resources and spare women the anxiety and difficulty that surrounds invasive procedures. Better lesion classification also means improved diagnosis, which can lead to quicker and better treatment.”
