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European Radiology

, Volume 28, Issue 2, pp 565–572 | Cite as

Diagnostic value of the stand-alone synthetic image in digital breast tomosynthesis examinations

  • Julia Garayoa
  • Margarita ChevalierEmail author
  • Maria Castillo
  • Ignacio Mahillo-Fernández
  • Najim Amallal El Ouahabi
  • Carmen Estrada
  • Alejandro Tejerina
  • Olivia Benitez
  • Julio Valverde
Breast

Abstract

Objective

To demonstrate the non-inferiority of synthetic image (SI) mammography versus full-field digital mammography (FFDM) in breast tomosynthesis (DBT) examinations.

Methods

An observational, retrospective, single-centre, multireader blinded study was performed, using 2384 images to directly compare SI and FFDM based on Breast Imaging Reporting and Data System (BIRADS) categorisation and visibility of radiological findings. Readers had no access to digital breast tomosynthesis slices. Multiple reader, multiple case (MRMC) receiver operating characteristic (ROC) methodology was used to compare the diagnostic performance of SI and FFDM images. The kappa statistic was used to estimate the inter-reader and intra-reader reliability.

Results

The area under the ROC curves (AUC) reveals the non-inferiority of SI versus FFDM based on BIRADS categorisation [difference between AUC (ΔAUC), -0.014] and lesion visibility (ΔAUC, -0.001) but the differences were not statistically significant (p=0.282 for BIRADS; p=0.961 for lesion visibility). On average, 77.4% of malignant lesions were detected with SI versus 76.5% with FFDM. Sensitivity and specificity of SI are superior to FFDM for malignant lesions scored as BIRADS 5 and breasts categorised as BIRADS 1.

Conclusions

SI is not inferior to FFDM when DBT slices are not available during image reading. SI can replace FFDM, reducing the dose by 45%.

Key Points

Stand-alone SI demonstrated performance not inferior for lesion visibility as compared to FFDM.

Stand-alone SI demonstrated performance not inferior for lesion BIRADS categorisation as compared to FFDM.

Synthetic images provide important dose savings in breast tomosynthesis examinations.

Keywords

Digital breast tomosynthesis Digital mammography Synthetic image Lesion detectability BIRADS categorisation 

Abbreviations

DBT

Digital breast tomosynthesis

FFDM

Full-field digital mammography

SI

Synthetic image

C-View

Synthetic image commercial name

CC

Cranio-caudal view

MLO

Medio lateral oblique view

IDC

Invasive ductal carcinoma

DCIS

Ductal carcinoma in situ

ILC

Infiltrating lobular carcinoma

BIRADS

Breast Imaging and Reporting and Data System

MRMC

Multiple reader multiple case

ROC

Receiver operating characteristics

AUC

Area under the ROC curve

Notes

Acknowledgements

The authors would like to thank Arturo Carreto for his helpful collaboration in collecting data and the important contribution and assistance of the Radiology Protection Unit and Radiology Department of the Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain). They would also like to thank the representative of Hologic for the collaboration of EMSOR S.A. (Madrid, Spain).

Compliance with ethical standards

Guarantor

The scientific guarantor of this publication is: Margarita Chevalier.

Conflict of interest

One of the co-authors of this manuscript (Najim Amallal) declares a relationships with the company EMSOR, representative of Hologic Inc. in Spain.

The rest of the authors of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article.

Funding

The authors state that this work has not received any funding.

Statistics and biometry

One of the authors has significant statistical expertise.

Informed consent

Written informed consent was waived by the Comité Ético de Investigación Clínica del Hospital Universitario Fundación Jiménez Díaz.

Ethical approval

Institutional review board (Comité Ético de Investigación Clínica del Hospital Universitario Fundación Jiménez Díaz) approval was obtained.

Methodology

• Retrospective

• Observational

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Copyright information

© European Society of Radiology 2017

Authors and Affiliations

  • Julia Garayoa
    • 1
  • Margarita Chevalier
    • 2
    Email author
  • Maria Castillo
    • 2
  • Ignacio Mahillo-Fernández
    • 3
  • Najim Amallal El Ouahabi
    • 4
  • Carmen Estrada
    • 5
    • 6
  • Alejandro Tejerina
    • 5
    • 6
  • Olivia Benitez
    • 5
  • Julio Valverde
    • 1
  1. 1.Radiological Protection UnitHospital Universitario Fundación Jimenez DiazMadridSpain
  2. 2.Medical Physics Group, Radiology Department, Facultad de MedicinaUniversidad Complutense de MadridMadridSpain
  3. 3.Servicio de Epidemiología y BioestadísticaHospital Universitario Fundación Jimenez DiazMadridSpain
  4. 4.EMSORMadridSpain
  5. 5.Diagnostic Radiology DepartmentHospital Universitario Fundación Jimenez DiazMadridSpain
  6. 6.Centro de Patología de la MamaFundación TejerinaMadridSpain

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