A New Diagnostic Criterion with Gadoxetic Acid-Enhanced MRI May Improve the Diagnostic Performance for Hepatocellular Carcinoma

Background To prospectively establish and validate new diagnostic criterion (DC) for liver-specific contrast agents and further compared the diagnostic sensitivity and specificity with conventional DC. Methods Institutional Review Board approved and written informed consent were obtained for this prospective study. Two board-certified reviewers established the reference standard as hepatocellular carcinoma (HCC), non-HCC lesions by using marks on all cross-sectional MR images. Another 2 abdominal radiologists independently performed the marked lesion observations using 5 different DCs, including DC-1: arterial phase hyperenhancement (APHE) and portal venous phase washout; DC-2: APHE and hepatobiliary phase (HBP) hypointensity; DC-3: APHE and diffusion-weighted imaging (DWI) hyperintensity; DC-4: HBP hypointensity and DWI hyperintensity; DC-5: HBP hypointensity, DWI hyperintensity and excluded these markedly T2 hyperintensity. Diagnostic performance of sensitivity, specificity, and accuracy for each imaging DC was calculated, per-lesion diagnostic sensitivity and specificity of imaging criteria were compared by using McNemars test. Results A total of 215 patients were included (mean age 53.82 ± 11.24 years; range 24-82 years) with 265 hepatic nodules (175 HCCs and 90 non-HCCs). The DC-4 (93.71%; 164/175) and DC-5 (92.57%; 162/175) yielded the highest diagnostic sensitivity and was better than DC-1 (72.57%; 127/175), DC-2 (82.86%; 145/175), and DC-3 (82.29%; 144/175) (all p < 0.001). The specificity of DC-1 (94.44%; 85/90) was significantly higher than that with DC-2 (83.33%; 75/90), DC-3 (84.44%; 76/90), DC-4 (74.44%; 67/90), and DC-5 (82.22%; 74/90) (all p < 0.05). Additionally, the DC-4 and DC-5 achieved the highest area under curve value of 0.841 (95% CI 0.783-0.899) and 0.874 (95% CI 0.822-0.925). Conclusions The combined use of HBP hypointensity and DWI hyperintensity as a new DC for HCC enables a high diagnostic sensitivity and comparable specificity.