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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07768085
Lead Sponsor Shengjing Hospital
Conditions
(from sponsor)		 Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Hepatic Metastasis, Hepatic Hemangioma, Cyst, Focal Nodular Hyperplasia
Related terms Carcinoma, Hepatocellular, Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Cysts, Focal Nodular Hyperplasia
Enrollment 40,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov