Clinical impact of CEUS on non-characterizable observations and observations with intermediate probability of malignancy on CT/MRI in patients at risk for HCC

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2024年6月11日

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Yuko Kono,
F. Piscaglia,
S. R. Wilson,
A. Medellin,
S. K. Rodgers,
V. Planz,
A. Kamaya,
D. T. Fetzer,
A. Berzigotti,
P. S. Sidhu,
C. E. Wessner,
K. Bradigan,
Cristina M. Kuon Yeng Escalante,
T. Siu Xiao,
J. R. Eisenbrey,
F. Forsberg,
A. Lyshchik,
Gibran T. Yusuf,
Abid Suddle,
Vasileios D. Rafailidis,
Lorenzo Mulazzani,
Alessandro Granito,
Eleonora Terzi,
Antonella Forgione,
Alice Giamperoli,
Bernardo Stefanini,
Iuliana-Pompilia Radu,
Lisa Finch,
Amit G. Singal

摘要

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.