Clinical validation of contrast-enhanced ultrasound liver imaging reporting and data system in a prospective multinational study in North America and Europe.
Hepatology (Baltimore, Md.)
BACKGROUND AIMS: The objective of this study is to determine diagnostic accuracy of the American College of Radiology Contrast-Enhanced Ultrasound (CEUS) Liver Imaging Reporting and Data System (LI-RADS) LR-5 characterization for HCC diagnosis in North American or European patients.
APPROACH RESULTS: Prospective multinational cohort study was performed from 01/2018 through 11/2022 at 11 academic and nonacademic centers in North America and Europe. Patients at risk for HCC with at least one liver observation not previously treated, identified on ultrasound (US) or multiphase CT or MRI performed as a part of standard clinical care were eligible for the study. All participants were examined with CEUS of the liver within 4 weeks of CT / MRI or tissue diagnosis to characterize up to 2 liver nodules per participant using ACR CEUS LI-RADS. Definite HCC diagnosis on the initial CT/MRI, imaging follow-up, or histology for CT/MRI-indeterminate nodules were used as reference standard. A total 545 nodules had confirmed reference standard in 480 patients, 73.8% were HCC, 5.5% other malignancy, and 20.7% were non-malignant. The specificity of CEUS LR-5 for HCC was 95.1% (95% CI 90.1% - 97.7%), sensitivity 62.9% (95% CI 57.9%-67.7%), Positive Predictive Value (PPV) 97.3% (95% CI 94.5% - 98.7%), and Negative Predictive Value (NPV) 47.7% (95% CI 41.7% - 53.8%). In addition, benign CEUS characterization (LR-1 or LR-2) had 100% specificity and 100% PPV for non-malignant liver nodules.
CONCLUSIONS: CEUS LI-RADS characterization provides accurate categorization of liver nodules in participants at risk for HCC. ClinicalTrials.gov ID NCT03318380.
Women & Children
Lyshchik, Andrej; Wessner, Corinne E; Bradigan, Kristen; Eisenbrey, John R; Forsberg, Flemming; Yi, Misung; Keith, Scott W; Kono, Yuko; Wilson, Stephanie R; Medellin, Alexandra; Rodgers, Shuchi K; Planz, Virginia; Kamaya, Aya; Finch, Lisa; Fetzer, David; Berzigotti, Annalisa; Sidhu, Paul S; and Piscaglia, Fabio, "Clinical validation of contrast-enhanced ultrasound liver imaging reporting and data system in a prospective multinational study in North America and Europe." (2023). Articles, Abstracts, and Reports. 7763.