Status:
RECRUITING
Artificial Intelligence vs. LIRADS in Diagnosing HCC on CT
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Education University of Hong Kong
Conditions:
HCC
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ra...
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 ...
Eligibility Criteria
Inclusion
- 1\. Age \>=18 years. 2. Defined as the at-risk population requiring regular liver ultrasonography surveillance. These include:
- Cirrhotic patients of any disease etiology,
- Chronic hepatitis B patients of age ≥40 years for men, age ≥50 years for women or with a family history of HCC.
- 3\. At least one new-onset focal liver nodule detected on liver ultrasonography.
Exclusion
- Liver nodules of \<1 cm. Currently such nodules are not reported using LI-RADS criteria but are recommended for a repeat scan in 3-6 months. In patients with multiple liver nodules, the largest nodule will be assessed.
- Patients with contraindications for contrast CT imaging, including a history of contrast anaphylaxis and impaired renal function (glomerular filtration rate \<30 ml/min).
- Patients with prior transarterial chemoembolization or other interventional procedures with intrahepatic injection of lipiodol. Lipiodol is extremely hyperdense on computed tomography and will preclude objective interpretation. Such patients were also excluded in the development of our prototype AI algorithm.
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04843176
Start Date
March 19 2021
End Date
June 30 2026
Last Update
May 18 2022
Active Locations (1)
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1
Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong