Diagnostic Accuracy of Contrast-Enhanced, Spectral Mammography (CESM) and 3T Magnetic Resonance Compared to Full-Field Digital Mammography plus Ultrasound in Breast Lesions: Results of a (Pilot) Open-Label, Single-Centre Prospective Study

SIMPLE SUMMARY: The characterization of breast lesions by magnetic resonance imaging (MRI) is influenced by a high rate of false positives. Contrast-enhanced spectral mammography (CESM) is a promising modality that seems to compensate for the high costs, times and main limitations of MRI. The aim of our prospective study was to evaluate the diagnostic accuracy of CESM in comparison to 3T MRI imaging in the characterization of breast lesions. We enrolled 118 patients and histologically assessed 142 breast lesions. Patients underwent full-field digital mammography (FFDM), ultrasound (US), with CESM and MRI assessing the diagnostic accuracy of CESM. Sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) were considered as measures of accuracy of different diagnostic procedures in predicting the nature and characteristics of the examined breast lesions. ABSTRACT: Introduction: To assess the diagnostic accuracy of CESM and 3T MRI compared to full-field digital mammography (FFDM), plus US, in the evaluation of advanced breast lesions. Materials and Methods: Consenting women with suspicious findings underwent FFDM, US, CESM and 3T MRI. Breast lesions were histologically assessed, with histology being the gold standard. Two experienced breast radiologists, blinded to cancer status, read the images. Diagnostic accuracy of (1) CESM as an adjunct to FFDM and US, and (2) 3T MRI as an adjunct to CESM compared to FFDM and US, was assessed. Measures of accuracy were sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV). Results: There were 118 patients included along with 142 histologically characterized lesions. K agreement values were 0.69, 0.68, 0.63 and 0.56 for concordance between the gold standard and FFDM, FFDM + US, CESM and MRI, respectively (p < 0.001, for all). K concordance for CESM was 0.81 with FFDM + US and 0.73 with MRI (p value < 0.001 for all). Conclusions: CESM may represent a valuable alternative and/or an integrating technique to MRI in the evaluation of breast cancer patients.