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RECRUITING
NCT04843176
NA

Artificial Intelligence vs. LIRADS in Diagnosing HCC on CT

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

Liver cancer is the sixth most commonly diagnosed cancer and the fourth leading cause of cancer death worldwide. It is the 3rd most common cause of cancer death in Hong Kong. The five-year survival rates of liver cancer differ greatly with disease staging, ranging from 91.5% in early-stage to 11% in late-stage. The early and accurate diagnosis of liver cancer is paramount in improving cancer survival. Liver cancer is diagnosed radiologically via cross sectional imaging, e.g. computed tomography (CT), without the routine use of liver biopsy. However, with current internationally-recommended radiological reporting methods, up to 49% of liver lesions may be inconclusive, resulting in repeated scans and a delay in diagnosis and treatment. An artificial intelligence (AI) algorithm that that can accurately diagnosed liver cancer has been developed. Based on an interim analysis, the algorithm achieved a high diagnostic accuracy. The AI algorithm is now ready for implementation. This study aims to prospective validate this AI algorithm in comparison with the current standard of radiological reporting in a randomized manner in the at-risk population undergoing triphasic contrast CT. This research project is totally independent and separated from the actual clinical reporting of the CT scan by the duty radiologist. The primary study outcome is the diagnostic accuracy of liver cancer, which will be unbiasedly based on a composite clinical reference standard.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2021-03-19

Completion Date

2026-06-30

Last Updated

2022-05-18

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Prototype artificial intelligence algorithm

Developed by the University of Hong Kong

DIAGNOSTIC_TEST

LI-RADS

The Liver Imaging Reporting and Data System (LI-RADS) was established to standardize the lexicon, interpretation and communication of radiological findings related to HCC

Locations (1)

Department of Medicine, The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong