RecruitingNot ApplicableNCT04843176

Artificial Intelligence vs. LIRADS 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


Sponsor

The University of Hong Kong

Enrollment

250 participants

Start Date

Mar 19, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an artificial intelligence (AI) tool can diagnose liver cancer (hepatocellular carcinoma, or HCC) from CT scans as accurately as — or better than — the current standard radiologist scoring system (called LI-RADS), potentially enabling faster and more accurate diagnosis. **You may be eligible if:** - You are 18 or older - You are considered at risk for liver cancer and already receive regular liver ultrasound monitoring — for example, because you have liver cirrhosis or have chronic hepatitis B - A new liver nodule (growth) was found on your liver ultrasound **You may NOT be eligible if:** - The liver nodule found is smaller than 1 cm - You cannot receive contrast dye during a CT scan due to a history of severe allergic reaction or poor kidney function - You have previously had a procedure that injected a substance called lipiodol into the liver, as this interferes with CT imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTPrototype artificial intelligence algorithm

Developed by the University of Hong Kong

DIAGNOSTIC_TESTLI-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04843176


Related Trials