Aixplorer ShearWave Elastography for ultrasound imaging and assessing suspicious breast lesions

The Aixplorer system's ShearWave Elastography mode adds qualitative and quantitative elasticity data to 2D and 3D ultrasound imaging, for characterising breast lesions and detecting breast cancer.

Aixplorer ShearWave Elastography is likely to be used as an adjunct to B‑mode greyscale ultrasound for women who are referred to breast assessment clinics, either following positive mammography or ultrasound screening, or as a symptomatic referral from primary care.

Fourteen diagnostic accuracy studies reporting quantitative Aixplorer ShearWave Elastography 2D parameters against a reference standard (biopsy) were identified. Of these, 5 papers that also estimated the potential impact of the technology on clinical pathways were selected for review (n=78–958).

One large study (n=939 lesions in 958 women) concluded that the addition of Aixplorer ShearWave Elastography has the potential to improve specificity of breast lesion characterisation (that is, reduce false‑positive results) compared with B‑mode greyscale ultrasound alone, without loss of sensitivity.

Three smaller studies (n=78 to n=142) reported that Aixplorer ShearWave Elastography has the potential to improve ultrasound specificity (reduce false‑positive results) and reduce unnecessary biopsies.

One study (n=173) found that adding Aixplorer ShearWave Elastography to ultrasound improved sensitivity.

All 5 studies used retrospective analysis to set elasticity thresholds.

None of the studies showed a direct impact on clinical pathways.

No prospective randomised controlled trials reporting the Aixplorer system's impact on clinical pathways were identified.

The Aixplorer system is for use by qualified sonographers and radiologists who are familiar with ultrasound elastography and specifically trained to use the system. It is 1 of 2 ultrasound systems currently available which use dynamic shear wave elastography to quantitatively measure tissue stiffness.

The Aixplorer system conforms to the Digital Imaging and Communications in Medicine (DICOM) 3.0 standard for the communication and management of medical imaging information and related data.

The Aixplorer system (including the ShearWave Elastography mode) costs £80,095, including a single, reusable transducer for breast imaging.

No published evidence on resource consequences was identified.