Diagnostic value of the stand-alone synthetic image in digital breast tomosynthesis examinations
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To demonstrate the non-inferiority of synthetic image (SI) mammography versus full-field digital mammography (FFDM) in breast tomosynthesis (DBT) examinations.
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.
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.
SI is not inferior to FFDM when DBT slices are not available during image reading. SI can replace FFDM, reducing the dose by 45%.
• 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.
KeywordsDigital breast tomosynthesis Digital mammography Synthetic image Lesion detectability BIRADS categorisation
Digital breast tomosynthesis
Full-field digital mammography
Synthetic image commercial name
Medio lateral oblique view
Invasive ductal carcinoma
Ductal carcinoma in situ
Infiltrating lobular carcinoma
Breast Imaging and Reporting and Data System
Multiple reader multiple case
Receiver operating characteristics
Area under the ROC curve
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
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.
The authors state that this work has not received any funding.
Statistics and biometry
One of the authors has significant statistical expertise.
Written informed consent was waived by the Comité Ético de Investigación Clínica del Hospital Universitario Fundación Jiménez Díaz.
Institutional review board (Comité Ético de Investigación Clínica del Hospital Universitario Fundación Jiménez Díaz) approval was obtained.
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