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Initial results of the FUSION-X-US prototype combining 3D automated breast ultrasound and digital breast tomosynthesis

  • Breast
  • Published:
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Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.

Key Points

  • 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.

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Abbreviations

ABVS:

Automated breast volume sonography

BI-RADS:

Breast Imaging-Reporting and Data System

CC:

Craniocaudal

FDA:

Food and Drug Administration

HHUS:

Hand-held ultrasound

HIPAA:

Health Information Portability and Accountability Act of 1996 (HIPAA)

ML:

Mediolateral

MLO:

Mediolateral-oblique

SD:

Standard deviation

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Funding

This study has received funding by Siemens Health Care GmbH.

Author information

Authors and Affiliations

  1. Department of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany

    Benedikt Schaefgen, Joerg Heil, Aba Harcos, Christina Gomez, Anne Stieber, André Hennigs, Alexandra von Au, Julia Spratte, Joachim Rom, Florian Schütz, Christof Sohn & Michael Golatta

  2. Northeastern Ohio Medical University and Southwoods Imaging, Youngstown, OH, USA

    Richard G. Barr

  3. Siemens Healthcare GmbH, Siemensstr. 3, 91301, Forchheim, Germany

    Marcus Radicke

  4. Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

    Geraldine Rauch

  5. Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany

    Geraldine Rauch

  6. Institute of Biometry and Clinical Epidemiology, Berlin Institute of Health, Berlin, Germany

    Geraldine Rauch

Authors
  1. Benedikt Schaefgen
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  2. Joerg Heil
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  3. Richard G. Barr
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  4. Marcus Radicke
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  5. Aba Harcos
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  6. Christina Gomez
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  7. Anne Stieber
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  8. André Hennigs
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  9. Alexandra von Au
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  10. Julia Spratte
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  11. Geraldine Rauch
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  12. Joachim Rom
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  13. Florian Schütz
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  14. Christof Sohn
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  15. Michael Golatta
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Corresponding author

Correspondence to Michael Golatta.

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Guarantor

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.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained.

Methodology

• prospective

• diagnostic

• performed at one institution

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Schaefgen, B., Heil, J., Barr, R.G. et al. Initial results of the FUSION-X-US prototype combining 3D automated breast ultrasound and digital breast tomosynthesis. Eur Radiol 28, 2499–2506 (2018). https://doi.org/10.1007/s00330-017-5235-8

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  • DOI: https://doi.org/10.1007/s00330-017-5235-8

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