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Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT

Shengjing Hospital · 2026
ClinicalTrials.gov · Datasets · License: Public Domain · 2026
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artificial-intelligencehepatocellular-carcinoma-hccna
The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, \*\*with the non-inferiority margin prespecified in the statistical analysis plan before enrollment\*\*, and whether it improves lesion detection, diagnostic characterization, downstream clinical management, and reporting efficiency. On AI-assisted center-days, AI results will be revealed only after the first-line radiologist has saved an unaided initial assessment and may be used to revise the final report. On control center-days, examinations will be interpreted using the standard radiology workflow without access to AI tools.
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