Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06626087

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

Led by The University of Hong Kong · Updated on 2024-10-29

250

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

Sponsors

T

The University of Hong Kong

Lead Sponsor

E

Education University of Hong Kong

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • At-risk population requiring regular liver ultrasonography surveillance
  • Cirrhotic patients of any disease cause
  • Chronic hepatitis B patients: men aged 40 or older, women aged 50 or older, or those with family history of hepatocellular carcinoma
  • At least one new liver nodule detected on liver ultrasound
Not Eligible

You will not qualify if you...

  • Liver nodules smaller than 1 cm
  • Contraindications to contrast CT imaging, including history of contrast allergy or kidney function with glomerular filtration rate below 30 ml/min
  • Prior transarterial chemoembolization or other liver procedures involving intrahepatic lipiodol injection

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

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

Hong Kong, Hong Kong

Actively Recruiting

2

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

Hong Kong, Hong Kong

Not Yet Recruiting

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Research Team

W

Wai-Kay Seto, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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