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European Radiology

, Volume 28, Issue 6, pp 2499–2506 | Cite as

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

  • Benedikt Schaefgen
  • Joerg Heil
  • Richard G. Barr
  • Marcus Radicke
  • Aba Harcos
  • Christina Gomez
  • Anne Stieber
  • André Hennigs
  • Alexandra von Au
  • Julia Spratte
  • Geraldine Rauch
  • Joachim Rom
  • Florian Schütz
  • Christof Sohn
  • Michael GolattaEmail author
Breast

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.

Keywords

Breast Cancer Ultrasonography Mammography Multimodal Imaging 

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

Notes

Funding

This study has received funding by Siemens Health Care GmbH.

Compliance with ethical standards

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

Supplementary material

330_2017_5235_MOESM1_ESM.docx (19 kb)
ESM 1 (DOCX 18 kb)

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Copyright information

© European Society of Radiology 2018

Authors and Affiliations

  • Benedikt Schaefgen
    • 1
  • Joerg Heil
    • 1
  • Richard G. Barr
    • 2
  • Marcus Radicke
    • 3
  • Aba Harcos
    • 1
  • Christina Gomez
    • 1
  • Anne Stieber
    • 1
  • André Hennigs
    • 1
  • Alexandra von Au
    • 1
  • Julia Spratte
    • 1
  • Geraldine Rauch
    • 4
    • 5
    • 6
  • Joachim Rom
    • 1
  • Florian Schütz
    • 1
  • Christof Sohn
    • 1
  • Michael Golatta
    • 1
    Email author
  1. 1.Department of Gynecology and ObstetricsUniversity Breast UnitHeidelbergGermany
  2. 2.Northeastern Ohio Medical University and Southwoods ImagingYoungstownUSA
  3. 3.Siemens Healthcare GmbHForchheimGermany
  4. 4.Institute of Medical Biometry and InformaticsUniversity of HeidelbergHeidelbergGermany
  5. 5.Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu BerlinBerlinGermany
  6. 6.Institute of Biometry and Clinical EpidemiologyBerlin Institute of HealthBerlinGermany

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