Abstract
ObjectivesTo assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety.MethodsThis prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) with at least 1 untreated focal liver lesion (FLL) (< 10 cm in diameter) underwent a contrast-enhanced ultrasound (CEUS) examination (218 received Sonazoid of 0.12 μL microbubbles/kg; 206 received SonoVue of 2.4 mL). Three independent blinded readers evaluated pre- and post-contrast images characterising the FLLs as benign or malignant.ResultsSonazoid-enhanced and SonoVue-enhanced ultrasound provided a statistically significant improvement in specificity for all 3 readers comparing to unenhanced ultrasound (for Sonazoid: p = 0.0093, < 0.0001, 0.0011; for SonoVue: p = 0.002, 0.03, 0.12, respectively). Difference in accuracy improvement between the 2 groups was within the pre-specified non-inferiority margin of 20% for all 3 readers (6.1%, 95% CI: − 5.0 to 17.2; − 7.5%, 95% CI: − 18.4 to 3.5; − 0.3%, 95% CI: − 11.3 to 10.7).The diagnostic confidence level for all 3 readers increased with post-contrast images relative to pre-contrast images. Both contrast agents were well tolerated.ConclusionResults showed a similar efficacy for Sonazoid™ and SonoVue® in diagnosing FLLs as benign or malignant, and underlined the benefit of CEUS imaging over unenhanced ultrasound imaging in reaching a confident diagnosis without having to refer patients for additional imaging exams.
Highlights
Contrast-enhanced ultrasound (CEUS) has an important role in diagnostic strategies of focal liver lesions (FLLs) as underlined in the WFUMB-EFSUMB guidelines [1]
The distribution of reference diagnoses for the target FLLs was similar across the Sonazoid and SonoVue groups as summarised in Table 2 (Fig. 1)
Examples of typical enhancement patterns of Hepatocellular Carcinoma (HCC) and focal nodular hyperplasia (FNH) on CEUS and reference diagnosis scans are shown in Figs. 2, 3 and 4
Summary
Contrast-enhanced ultrasound (CEUS) has an important role in diagnostic strategies of focal liver lesions (FLLs) as underlined in the WFUMB-EFSUMB guidelines [1]. CEUS has demonstrated similar diagnostic performance to computed tomography (CT) and magnetic resonance imaging (MRI), with advantages including real-time scanning and no radiation exposure [4,5,6,7]. The ultrasound contrast agents (UCA) currently used in CEUS are gas-filled microbubbles (3–10 μm diameter) stabilized by a flexible shell such as phospholipids or albumin. These microbubbles act as resonant entities in an ultrasound field, generating nonlinear scattered signals to discriminate the blood flow from surrounding tissue [8, 9].
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