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: BIRADS categorisation; Digital breast tomosynthesis; Digital mammography; Lesion detectability; Synthetic image.