CompletedNANCT06626087

A Prototype Artificial Intelligence Algorithm Versus Liver Imaging Reporting and Data System (LI-RADS) Criteria in Diagnosing Hepatocellular Carcinoma on Computed Tomography: a Randomized Trial

Sponsor: The University of Hong Kong

Trial Details

ConditionHepatocellular Carcinoma
InterventionPrototype artificial intelligence algorithm; LI-RADS
PhaseNA
StatusCompleted
Participants300
Est. Completion31 Mar 2026
Last Updated15 May 2026

Primary Outcome

Diagnostic accuracy for HCC

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * 1\. Age \>=18 years. * 2\. Defined as the at-risk population requiring regular liver ultrasonography surveillance. These include: 1. Cirrhotic patients of any disease etiology, 2. Chronic hepatitis B patients of age ≥40 years for men, age ≥50 years for women or with a family history of HCC. * 3\. At least one new-onset focal liver nodule detected on liver ultrasonography. Exclusion Criteria: * 1\. Liver nodules of \<1 cm. Currently such nodules are not reported using LI-RADS criteria but are recommended for a repeat scan in 3-6 months. In patients with multiple liver nodules, the largest nodule will be assessed. * 2\. Patients with contraindications for contrast CT imaging, including a history of contrast anaphylaxis and impaired renal function (glomerular filtration rate \<30 ml/min). * 3\. Patients with prior transarterial chemoembolization or other interventional procedures with intrahepatic injection of lipiodol. Lipiodol is extremely hyperdense on computed tomography and will preclude objective interpretation. Such patients were also excluded in the development of our prototype AI algorithm.

Trial Sites

Countries

Hong Kong
View Registry Entry

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