Clinical trial · Interventional
Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis
Evaluation of Diagnostic Accuracy of Contrast-enhanced Ultrasound (CEUS) and Gadoxetic Acid-enhanced Liver MRI for Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis
- 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 compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).
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 |
|---|---|---|---|
| contrast-enhanced ultrasound | Diagnostic Test | — | UNRESOLVED |
| EOB-MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hepatic nodule group
- description
- This group meets eligibility criteria, and undergo contrast-enhanced ultrasound (CEUS) and scheduled gadoxetic acid MRI (gadoxetic acid-enhanced liver MRI; EOB-MRI; Gd-EOB-MRI)
- interventionNames
- Diagnostic Test: contrast-enhanced ultrasound
- Diagnostic Test: EOB-MRI
Primary outcomes (1)
- measure
- Diagnostic performance of CEUS for diagnosing HCC
- timeFrame
- 3 months after CEUS
- description
- accuracy, sensitivity, specificity of CEUS for HCC diagnosis
Secondary outcomes (2)
- measure
- Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * High risk group of developing HCC * hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT) * newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year * scheduled for gadoxetic acid-enhanced liver MRI * signed informed consent Exclusion Criteria: * hypersensitivity for ultrasound contrast media * pregnancy * history of recent treatment for HCC in a year * standard of reference is not available * severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)
References
Publications (0)
Data not yet available