NCT06626087

A Prototype AI Algorithm Versus Liver Imaging Reporting and Data System (LI-RADS) Criteria in Diagnosing HCC on CT

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 to compare the diagnostic performance of the prototype AI algorithm versus LI-RADS criteria in determining HCC on CT in the at-risk population.

Detailed description

Liver cancer is the sixth most commonly diagnosed cancer and the fourth leading cause of cancer death worldwide. The main disease burden is found in East Asia, in which the age-standardized incidence is 26.8 and 8.7 per 100,000 in men and women respectively. In 2017, among the top 10 most common cancers in Hong Kong, liver cancer had the highest case fatality rate of 84.6%. The five-year survival rates of hepatocellular carcinoma (HCC) differ greatly with disease staging, ranging from 91.5% in \<2 cm with surgical resection to 11% in \>5 cm with adjacent organ involvement. The early and accurate diagnosis of HCC is paramount in improving cancer survival. Unlike other common cancers, HCC is diagnosed by highly characteristic dynamic patterns on contrast-enhanced cross sectional imaging, without the need of pathological confirmation. The Liver Imaging Reporting and Data System (LI-RADS) was established to standardize the lexicon, interpretation and communication of radiological findings related to HCC. However, up to 49% of nodules identified in computed tomography (CT) in the at-risk population are categorized by LI-RADS as indeterminate, further delaying the establishment of diagnosis. There are currently studies pioneering the application of artificial intelligence (AI) in the field of medical imaging. An interdisciplinary research team of clinicians, radiologists and statistical scientists, based on the clinical and radiological database of over 4,000 liver images, have developed an AI algorithm to accurately diagnose liver cancer on CT. Based on retrospective data, an interim analysis found the AI algorithm able to achieve a diagnostic accuracy of \>97% and a negative predictive value of \>99%. If the prototype AI algorithm proves to have a better one-off diagnostic performance when compared to LI-RADS, it can facilitate the earlier diagnosis of HCC, allowing earlier definitive treatment and improving cancer survival.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Prototype artificial intelligence algorithm	Developed by the University of Hong Kong
DIAGNOSTIC_TEST	LI-RADS	The Liver Imaging Reporting and Data System (LIRADS) was established to standardize the lexicon, interpretation and communication of radiological findings related to HCC

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2024-10-03
• Last updated: 2024-10-29

Locations

2 sites across 1 country: Hong Kong