Breast assessment using next generation handheld ultrasound device based on silicon chips: a pilot study in senology

In breast care, ultrasound examination is a very important tool used to detect breast tumors, to monitor core needle biopsies, for preparing surgical operations, and for tracking postoperative developments. So far, stationary high-end ultrasound devices (SHUD) based on piezoelectric technology are most commonly used but lack the mobility and thus the possibility to practice point-of-care ultrasound (POCUS) in senology. In contrast, handheld ultrasound devices based on silicon chips (HHUD) offer a high mobility and different penetration depths through its all-in-one probe principle and thus may improve patient treatment. Therefore, this study investigates the diagnostic reliability of breast lesions examined with HHUD based on silicon chips versus those examined with SHUD based on conventional piezoelectric technology.

Each patient received an ultrasound examination using SHUD (Voluson S10, GE Healthcare) and HHUD (Butterfly iQ, Butterfly Network) in a random order. The morphologic descriptors and the BI-RADS categories, as well as the histological results, in the case of the biopsy, were compared, and the agreement rate and the Cohen's kappa were analyzed. A quantitative analysis of the lesions' sizes examined by the two devices was assessed statistically through intra-class correlation coefficient (ICC), Bland-Altman plots, and Pearson correlation coefficient (PCC). Subgroup analysis was performed in lesions' type, skin-to-lesion distance, and lesions' volume.

105 lesions found in 84 females were analyzed regarding the reliability of SHUD and HHUD. The BI-RADS categories matched perfectly between both the devices and the available histological outcomes. The agreements of the measured diameters were excellent (ICC 0.926-0.969). The subgroup analysis revealed a slightly superior agreement for malignant cases, for lesions over 0.5 ml and for a skin-to-lesion distance over 5 mm.

The categories and measurements from HHUD matched closely with those obtained using conventional SHUD. This research demonstrates that HHUD offers a good alternative to SHUD for breast lesion evaluation which becomes especially useful during point-of-care applications.