Clinical value of contrast-enhanced ultrasonography in the characterization of focal liver lesions: a prospective multicenter trial.

BACKGROUND Contrast-enhanced ultrasonography (CEUS) is increasingly accepted in clinical settings for diagnostic imaging of focal liver lesions (FLLs). This study aimed to assess the efficacy of CEUS in the characterization of FLLs in comparison with final diagnosis based on gold standard assessment. METHODS The study was approved by the local ethics committee and participating patients provided written informed consent. A total of 148 patients with 164 FLLs were studied. Unenhanced ultrasonography (US) and CEUS were performed using fundamental and harmonic imaging, respectively. Contrast enhancement was assessed during the arterial, portal and late vascular phases after intravenous administration of contrast (SonoVue, Bracco, Italy). Sensitivity, specificity and diagnostic accuracy of US and CEUS were compared in identifying the lesion as benign, malignant or indeterminate and its actual tumor type. Final diagnosis was established by biopsy (129/164), MR imaging (11/164) or medical history (24/164). RESULTS When compared to the gold standard, the number of indeterminate diagnoses was reduced from 56.7% (93/164) as assessed by fundamental imaging to 6.1% (10/164) after SonoVue enhanced US examination. Sensitivity and specificity improved from 49% and 25% at baseline US to 93% and 75% with CEUS, respectively (P<0.01). Diagnostic accuracy of CEUS was 88% in contrast to 41% of baseline US. CONCLUSION SonoVue enhanced US improves the characterization of FLLs and may limit the need for further investigations.