First proof-of-concept evaluation of the FUSION-X-US-II prototype for the performance of automated breast ultrasound in healthy volunteers
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Published:2021-05-10
Issue:2
Volume:304
Page:559-566
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ISSN:0932-0067
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Container-title:Archives of Gynecology and Obstetrics
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language:en
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Short-container-title:Arch Gynecol Obstet
Author:
Schaefgen Benedikt, Juskic Marija, Hertel Madeleine, Barr Richard G., Radicke Marcus, Stieber Anne, Hennigs André, Riedel Fabian, Sohn Christof, Heil Joerg, Golatta MichaelORCID
Abstract
Abstract
Purpose
The FUSION-X-US-II prototype was developed to combine 3D-automated breast ultrasound (ABUS) and digital breast tomosynthesis in a single device without decompressing the breast. We evaluated the technical function, feasibility of the examination workflow, image quality, breast tissue 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 30 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
One hundred and six scans were performed (61 × CC, 23 × ML, 22 × MLO) in 60 breasts. Image acquisition and processing by the prototype was fast and accurate. Breast coverage by ABUS was approximately 90.8%. Sixteen 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.
Funder
Siemens Healthcare GmbH Universitätsklinikum Heidelberg
Publisher
Springer Science and Business Media LLC
Subject
Obstetrics and Gynecology,General Medicine
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