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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03742453

Enrollment

117

Registered

2018-11-15

Start date

2018-10-16

Completion date

2021-12-31

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

CEUS, gadoxetic acid, MRI

Brief summary

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).

Interventions

DIAGNOSTIC_TESTcontrast-enhanced ultrasound

CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.

DIAGNOSTIC_TESTEOB-MRI

EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance of CEUS for diagnosing HCC	3 months after CEUS	accuracy, sensitivity, specificity of CEUS for HCC diagnosis

Secondary

Measure	Time frame	Description
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018	3 months after MRI	accuracy, sensitivity, specificity of MRI using LI-RADS v2018 for HCC diagnosis
Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018	3 months after MRI	accuracy, sensitivity, specificity of MRI using KLCSG-NCC guideline v2018 for HCC diagnosis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026