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- Title
Prospective assessment of diagnostic efficacy and safety of Sonazoid<sup>TM</sup> and SonoVue<sup>®</sup> ultrasound contrast agents in patients with focal liver lesions.
- Authors
Lv, Ke; Zhai, Hongyan; Jiang, Yuxin; Liang, Ping; Xu, Hui-Xiong; Du, Lianfang; Chou, Yi-Hong; Xie, Xiaoyan; Luo, YuKun; Lee, Young Joon; Lee, Jae Young; Hu, Bing; Luo, Baoming; Wang, Yi; Luan, Ying; Kalli, Christina; Chen, Kun; Wang, Wenping; Liang, Ja-Der
- Abstract
Objectives: To assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety. Methods: This 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. Results: Sonazoid-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. Conclusion: Results 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.
- Subjects
SOUTH Korea; CHINA; ULTRASOUND contrast media; CONTRAST-enhanced ultrasound; CONTRAST media; ULTRASONIC imaging; LIVER
- Publication
Abdominal Radiology, 2021, Vol 46, Issue 10, p4647
- ISSN
2366-004X
- Publication type
Article
- DOI
10.1007/s00261-021-03010-1