First proof-of-concept evaluation of the FUSION-X-US-II prototype for the performance of automated breast ultrasound in healthy volunteers

Purpose The FUSION-X-US-II prototype was developed to put a combination of 3D-automated breast ultrasound (ABUS) and digital breast tomosynthesis in a single device into practice. In this study, we evaluated the technical function, feasibility of the examination workflow, image quality, coverage and patient comfort of the ABUS device of the new prototype.

Methods In this prospective feasibility study, the FUSION-X-US-II prototype was used to perform ABUS in healthy volunteers without history of breast cancer. The ABUS images of the prototype were interpreted by a physician with specialization in breast diagnostics. Any detected lesions were measured and classified using BI-RADS^® scores. Image quality was rated subjectively by the physician and coverage of the breast was measured. Patient comfort was evaluated by a questionnaire after the examination.

Results 30 volunteers were recruited. 106 scans were performed (61 x CC, 23 x ML, 22 x MLO) in 60 breasts. Image acquisition and processing by the prototype was fast and accurate. Breast coverage by ABUS was approximately 90.8 %. 16 breast lesions (all benign, classified as BIRADS^® 2) were identified. The examination was tolerated by all patients.

Conclusion The FUSION-X-US-II prototype allows a rapid ABUS scan with mostly high patient comfort. Technical developments resulted in an improvement of quality and coverage compared to previous prototype versions. The results are encouraging for a test of the prototype in a clinical setting in combination with tomosynthesis.

Publication History

Article published online:
24 June 2020