Role of contrast-enhanced ultrasound in the blinded assessment of focal liver lesions in comparison with MDCT and CEMRI: Results from a multicentre clinical trial

Abstract

The main aim of this multicentre prospective study was to determine the clinical value of SonoVue ® administration for the characterisation of focal liver lesions incidentally detected in oncological or cirrhotic patients. Eight hundred and seventy four consecutive patients with 1034 nodules (diameter between 5 and 100 mm) not fully characterised by conventional US or previous single-phase CT-scan were imaged using real-time contrast-enhanced scanning after intravenous injection of 2.4 ml of SonoVue ® Blinded off-site assessment was conducted to evaluate the diagnostic performance of contrast-enhanced ultrasound (CEUS) in comparison with gold standard, i.e. triphasic CT-scan or contrast-enhanced MRI or histology. In the differentiation between benign and malignant lesions, CEUS yielded a sensitivity of 79.4% and a specificity of 88.1%. In the subgroup of patients with cirrhosis, the kappa value for off-site diagnosis between CEUS and reference modality was slightly lower compared to the non-cirrhotic group: 0.42 and 0.66 ( p = 0.0002), respectively. The concordance rate and kappa value of CEUS for benign to malignant differentiation between on-site and blinded review were 90.2% and 0.80%, respectively, compared to 83.4% and 0.66%, respectively, for the reference imaging technique. These results indicate that CEUS using SonoVue ® is a competitive and effective diagnostic tool for the characterisation of focal liver lesions compared to other modalities such as CT and MR imaging.