SOFIA: A Novel Automated Breast Ultrasound System Used on Patients in the Prone Position: A Pilot Study on Lesion Detection in Comparison to Handheld Grayscale Ultrasound.

Abstract

Introduction Most of the currently available automated breast ultrasound systems require patients to be in the supine position. Previous data, however, show a high recall rate with this method due to artifacts. The novel automated breast ultrasound scanner SOFIA scans the breast with the patient in a prone position, resulting in even compression of breast tissue. We present our initial results with this examination method. Material and Methods 63 patients were analyzed using a handheld B-mode ultrasound. In cases of BI-RADS 1, 2 or 5, a SOFIA scan was performed. Sensitivity, specificity and accuracy were calculated. Interobserver agreement was evaluated using Cohenʼs kappa. The duration of the scan was measured for both methods. Results No BI-RADS 5 lesion was missed with SOFIA. The SOFIA had an additional recall rate of 16.67% compared to B-mode ultrasound. The sensitivity, specificity and accuracy of SOFIA was 100, 83.33 and 88.89%, respectively. Cohenʼs kappa showed substantial agreement (κ = 0.769) between examiner 1 (B-mode) and examiner 2 (SOFIA). The mean scan duration for the B-mode system and the SOFIA system was 24.21 minutes and 12.94 minutes, respectively. In four cases, D-cup breasts were not scanned in their entirety. Conclusion No cancer was missed when SOFIA was used in this preselected study population. The scanning time was approximately half of that required for B-mode ultrasound. The additional unnecessary recall rate was 16.67%. Larger D cup-size breasts were difficult to position and resulted in an incomplete image in four cases.