Abstract

The aim of this prospective study was to compare the diagnostic performance of contrast-enhanced mammography (CEM) versus digital mammography (DM) combined with breast ultrasound (BUS) in women with dense breasts. Between March 2021 and February 2022, patients eligible for CEM with the breast composition category ACR BI-RADS c-d at DM and an abnormal finding (BI-RADS 3-4-5) at DM and/or BUS were considered. During CEM, a nonionic iodinated contrast agent (Iohexol 350 mg I/mL, 1.5 mL/kg) was power-injected intravenously. Images were evaluated independently by two breast radiologists. Findings classified as BI-RADS 1-3 were considered benign, while BI-RADS 4-5 were considered malignant. In case of discrepancies, the higher category was considered for DM+BUS. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were calculated, using histology/≥12-month follow-up as gold standards. In total, 51 patients with 65 breast lesions were included. 59 (90.7%) abnormal findings were detected at DM+BUS, and 65 (100%) at CEM. The inter-reader agreement was excellent (Cohen's k = 0.87 for DM+BUS and 0.97 for CEM). CEM showed a 93.5% sensitivity (vs. 90.3% for DM+BUS), a 79.4-82.4% specificity (vs. 32.4-35.5% for DM+BUS) (McNemar p = 0.006), a 80.6-82.9% PPV (vs. 54.9-56.0% for DM+BUS), a 93.1-93.3% NPV (vs. 78.6-80.0% for DM+BUS), and a 86.1-87.7% accuracy (vs. 60.0-61.5% for DM+BUS). The AUC was higher for CEM than for DM+BUS (0.865 vs. 0.613 for Reader 1, and 0.880 vs. 0.628, for Reader 2) (p < 0.001). In conclusion, CEM had a better diagnostic performance than DM and BUS alone and combined together in patients with dense breasts.

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