Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04843176

Artificial Intelligence vs. LIRADS in Diagnosing HCC on CT

Led by The University of Hong Kong · Updated on 2022-05-18

250

Participants Needed

1

Research Sites

275 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

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.

CONDITIONS

Official Title

Artificial Intelligence vs. LIRADS 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 ultrasound surveillance, including cirrhotic patients of any cause
  • Chronic hepatitis B patients aged 40 years or older for men, 50 years or older for women, or with a 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, including history of contrast allergy or impaired kidney function (glomerular filtration rate less than 30 ml/min)
  • Prior intrahepatic procedures like transarterial chemoembolization or other injections with lipiodol that affect CT interpretation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

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

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

W

Wai-Kay Seto, MD

CONTACT

K

Keith Chiu, FRCR

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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