Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC

A Single-Center, Prospective Study Comparing the Diagnostic Efficiencies of Contrast-Enhanced Ultrasound and EOB Contrast-Enhanced Magnetic Resonance Imaging for Lesions With Diameters ≤ 2cm in Patients With High Risk of HCC

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04212286

Enrollment

115

Registered

2019-12-26

Start date

2019-10-23

Completion date

2021-06-28

Last updated

2022-03-07

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

Conditions

Diagnoses Disease, Hepatocellular Cancer, Liver Cirrhoses

Keywords

Hepatocellular Cancer, Contrast-enhanced ultrasound, EOB-MRI, Diagnostic Efficacy

Brief summary

HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. In addition, atypical enhanced patterns caused by liver cirrhosis may also hinder imaging diagnosis of HCC. Therefore, early diagnosis of HCC in the context of cirrhosis remains a major clinical problem. Contrast-enhanced Ultrasound (CEUS) and MRI Contrast-enhanced Magnetic Resonance Imaging (CEMRI) are common diagnostic imaging methods. Till now, there is still lack of a detailed investigation comparing the diagnostic efficacies of CEUS and EOB-MRI for micro HCC in the context of cirrhosis. Therefore, this study aims to analyze the imaging patterns in CEUS and EOB-MRI for liver lesions with diameters ≤ 2 cm among patients with high risk of HCC, and to compare the diagnostic efficacies of EOB-MRI and CEUS for early-stage HCCs.

Interventions

DIAGNOSTIC_TESTDiagnostic CEUS and EOB-MRI

Undergo Sonovue-CEUS and EOB-MRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients are at high risk of HCC. 2. The ages of patients are between 18 and 80. 3. Patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (US/CT/MRI). 4. The number of lesions is less than or equal to 3. 5. Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days. 6. Patient signs the informed consent.

Exclusion criteria

1. Patient is with lesions confirmed by pathology or follow-up, or hemangiomas. 2. Patient is with lesions already undergoing local treatment, including thermal ablation or TACE. 3. Patient is with severe cardiopulmonary insufficiency. 4. Patient is a pregnant or breastfeeding women. 5. Patient is considered to be unsuitable to participate in the study.

Design outcomes

Primary

Measure	Time frame	Description
The sensitivity, specificity and accuracy of CEUS and EOB-MRI	6 to 12 months	The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.

Secondary

Measure	Time frame	Description
The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI	6 to 12 months	The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026