Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LI-RADS | Diagnostic Test | — | UNRESOLVED |
| Prototype artificial intelligence algorithm | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prototype AI algorithm
- description
- In-house prototype deep learning artificial intelligence algorithm
- interventionNames
- Diagnostic Test: Prototype artificial intelligence algorithm
- type
- PLACEBO_COMPARATOR
- label
- LI_RADS interpretation
- description
- LI-RADS criteria will be assessed independently by two specified abdominal radiologists with at least 10 years of experience in cross-sectional abdominal imaging
- interventionNames
- Diagnostic Test: LI-RADS
Primary outcomes (1)
- measure
- Diagnostic accuracy for HCC
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age \>=18 years. * 2\. Defined as the at-risk population requiring regular liver ultrasonography surveillance. These include: 1. Cirrhotic patients of any disease etiology, 2. 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 Criteria: * 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. * 2\. Patients with contraindications for contrast CT imaging, including a history of contrast anaphylaxis and impaired renal function (glomerular filtration rate \<30 ml/min). * 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.
References
Publications (0)
Data not yet available