1. Clinical impact of CEUS on non-characterizable observations and observations with intermediate probability of malignancy on CT/MRI in patients at risk for HCC.
- Author
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Kono, Yuko, Piscaglia, F., Wilson, S. R., Medellin, A., Rodgers, S. K., Planz, V., Kamaya, A., Fetzer, D. T., Berzigotti, A., Sidhu, P. S., Wessner, C. E., Bradigan, K., Kuon Yeng Escalante, Cristina M., Siu Xiao, T., Eisenbrey, J. R., Forsberg, F., Lyshchik, A., Yusuf, Gibran T., Suddle, Abid, and Rafailidis, Vasileios D.
- Subjects
ULTRASOUND contrast media ,MAGNETIC resonance imaging ,CONTRAST-enhanced ultrasound ,TUMOR diagnosis ,COMPUTED tomography - Abstract
Background: Hepatocellular carcinoma (HCC) is a unique cancer allowing tumor diagnosis with identification of definitive patterns of enhancement on contrast-enhanced imaging, avoiding invasive biopsy. However, it is still unclear to what extent Contrast-Enhanced Ultrasound (CEUS) is a clinically useful additional step when Computed tomography (CT) or Magnetic resonance imaging (MRI) are inconclusive. Methods: A prospective international multicenter validation study for CEUS Liver Imaging Reporting and Data System (LI-RADS) was conducted between January 2018 and August 2021. 646 patients at risk for HCC with focal liver lesions were enrolled. CEUS was performed using an intravenous ultrasound contrast agent within 4 weeks of CT/MRI. Liver nodules were categorized based on LI-RADS (LR) criteria. Histology or one-year follow-up CT/MRI imaging results were used as the reference standard. The diagnostic performance of CEUS was evaluated for inconclusive CT/MRI scan in two scenarios for which the AASLD recommends repeat imaging or imaging follow-up: observations deemed non-characterizable (LR-NC) or with indeterminate probability of malignancy (LR-3). Results: 75 observations on CT or MRI were categorized as LR-3 (n = 54) or LR-NC (n = 21) CEUS recategorization of such observations into a different LR category (namely, into one among LR-1, LR-2, LR-5, LR-M, or LR-TIV) resulted in management recommendation changes in 33.3% (25/75) and in all but one (96.0%, 24/25) observation, the new management recommendations were correct. Conclusion: CEUS LI-RADS resulted in management recommendations change in substantial number of liver observations with initial indeterminate CT/MRI characterization, identifying both non-malignant lesions and HCC, potentially accelerating the diagnostic process and alleviating the need for biopsy or follow-up imaging. ClinicalTrials.gov number, NCT03318380. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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