NCT06626087Completed
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
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 1 Oct 2024
- Start date
- 1 Nov 2023
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- The University of Hong Kong
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06626087
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 1 Nov 2023 to the primary completion date, 31 Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 3\. 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.
Other illness
- 2\. Patients with contraindications for contrast CT imaging, including a history of contrast anaphylaxis and impaired renal function (glomerular filtration rate \<30 ml/min).
Other
- 1\. 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Department of Medicine, The University of Hong Kong, Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.