A multicenter multinational retrospective study of the 1-year natural history of LI-RADS 3 observations in patients with cirrhosis.
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OBJECTIVES: To assess the 1-year natural history of liver imaging reporting and data system (LI-RADS) 3 observations on contrast-enhanced MRI in cirrhotic patients across multiple international centers, and to identify clinical and imaging predictors of progression using multivariable and machine learning models. MATERIALS AND METHODS: This retrospective study included 347 cirrhotic patients with 540 LI-RADS 3 observations from six centers across three countries, each with 12 (±3) months of follow-up MRI. Observations were reassessed using LI-RADS v2018 criteria. Generalized linear mixed-effects models and machine learning (LASSO, random forest) evaluated predictors of progression. Area under the curve (AUC) analysis assessed the predictive performance of clinical and imaging variables. RESULTS: Within one year, 28% of LI-RADS 3 observations progressed: 14% to LI-RADS 4 and 14% to LI-RADS 5. Independent predictors of progression included lesion size, with an odds ratio (OR: 1.12, 95% CI: 1.01-1.24), Child-Pugh Class C (OR: 8.36, 95% CI: 1.01-69.27), and alcohol-related liver disease (OR: 0.24, 95% CI: 0.06-0.94). Enhancing capsule and untreated hepatitis C virus were significant in univariable analysis. Imaging features improved predictive accuracy, increasing AUC from 0.65 to 0.72 (p = 0.01). A lesion size cut-off of 9.5 mm was associated with increased progression risk. CONCLUSION: One in four LI-RADS 3 observations progress within one year. Lesion size, liver function, and etiology are key predictors. Integration of imaging features enhances risk stratification and supports more personalized follow-up strategies for indeterminate liver lesions. KEY POINTS: Question Identifying which LI-RADS 3 liver observations progress to malignancy remains challenging; evidence from large, standardized, multicenter MRI cohorts is lacking. Findings In this large multinational study, 28% of LI-RADS 3 observations progressed within one year; lesion size, liver dysfunction, and disease etiology were key independent predictors. Clinical relevance LI-RADS 3 observations show significant progression risk, with imaging features improving prediction models and guiding surveillance strategies for early HCC detection.