Initial results of the FUSION-X-US prototype combining 3D automated breast ultrasound and digital breast tomosynthesis
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To determine the feasibility of a prototype device combining 3D-automated breast ultrasound (ABVS) and digital breast tomosynthesis in a single device to detect and characterize breast lesions.
In this prospective feasibility study, the FUSION-X-US prototype was used to perform digital breast tomosynthesis and ABVS in 23 patients with an indication for tomosynthesis based on current guidelines after clinical examination and standard imaging. The ABVS and tomosynthesis images of the prototype were interpreted separately by two blinded experts. The study compares the detection and BI-RADS® scores of breast lesions using only the tomosynthesis and ABVS data from the FUSION-X-US prototype to the results of the complete diagnostic workup.
Image acquisition and processing by the prototype was fast and accurate, with some limitations in ultrasound coverage and image quality. In the diagnostic workup, 29 solid lesions (23 benign, including three cases with microcalcifications, and six malignant lesions) were identified. Using the prototype, all malignant lesions were detected and classified as malignant or suspicious by both investigators.
Solid breast lesions can be localized accurately and fast by the Fusion-X-US system. Technical improvements of the ultrasound image quality and ultrasound coverage are needed to further study this new device.
The prototype combines tomosynthesis and automated 3D-ultrasound (ABVS) in one device.
It allows accurate detection of malignant lesions, directly correlating tomosynthesis and ABVS data.
The diagnostic evaluation of the prototype-acquired data was interpreter-independent.
The prototype provides a time-efficient and technically reliable diagnostic procedure.
The combination of tomosynthesis and ABVS is a promising diagnostic approach.
KeywordsBreast Cancer Ultrasonography Mammography Multimodal Imaging
Automated breast volume sonography
Breast Imaging-Reporting and Data System
Food and Drug Administration
Health Information Portability and Accountability Act of 1996 (HIPAA)
This study has received funding by Siemens Health Care GmbH.
Compliance with ethical standards
The scientific guarantor of this publication is PD Dr. Michael Golatta.
Conflict of interest
The prototype was provided by Siemens Healthcare GmbH. M. Radicke was the contact person for technical lead. Siemens did not have any influence on the results or evaluation of the study.
M. Golatta received payment for lectures from Siemens Ultrasound. R. Barr has equipment grants from Siemens ultrasound, Philips Ultrasound, B and K Ultrasound, and Hitachi-Aloka. He is on the speakers bureau for Philips Ultrasound and Bracoo Diagnostics. He is on the advisory panels of Bracco Diagnostics and Lantheus Medical. He receives royalties from Thieme Publishers.
Statistics and biometry
Prof. Geraldine Rauch kindly provided statistical advice for this manuscript, she has significant statistical expertise.
No complex statistical methods were necessary for this paper.
Written informed consent was obtained from all subjects (patients) in this study.
Institutional Review Board approval was obtained.
• performed at one institution
- 1.Gotzsche PC, Jorgensen KJ (2013) Screening for breast cancer with mammography. Cochrane Database Syst Rev Jun 4;:CD001877Google Scholar
- 15.Golatta M, Franz D, Harcos A et al (2013) Interobserver reliability of automated breast volume scanner (ABVS) interpretation and agreement of ABVS findings with hand held breast ultrasound (HHUS), mammography and pathology results. Eur J Rad 82:e332-e336.Google Scholar
- 17.Vourtsis A, Kachulis A (2017) The performance of 3D ABUS versus HHUS in the visualisation and BI-RADS characterisation of breast lesions in a large cohort of 1,886 women. Eur Radiol. https://doi.org/10.1007/s00330-017-5011-9
- 21.Wilczek B, Wilczek HE, Rasouliyan L, Leifland K (2016) Adding 3D automated breast ultrasound to mammography screening in women with heterogeneously and extremely dense breasts: Report from a hospital-based, high-volume, single-center breast cancer screening program. Eur J Radiol 85:1554–1563CrossRefPubMedGoogle Scholar
- 25.Sinha SP, Roubidoux MA, Helvie MA et al. (2007) IEEE Engineering in Medicine and Biology Society Annual Conference. 2007:1335–8Google Scholar
- 27.Sickles EA, D’Orsi CJ, Bassett LW, et al (2013) ACR BI-RADS mammography. In: D’Orsi CJ, Sickles EA, Mendelson EB, Morris EA, (ed) Breast Imaging Reporting and Data System: ACR BI-RADS—breast imaging atlas. 5th edn. Reston, VA. J Am Coll Radiol 272(2):309–315Google Scholar