Role of CEUS as a Secondary Diagnostic Modality

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: contrast enhanced ultrasound

• Registration Number: NCT04494022
• Lead Sponsor: Seoul National University Hospital

Brief Summary

To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.

Detailed Description

The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.

Study Timeline

• Study First Submitted: 2020-06-05
• Study Start: 2020-06-08
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-31
• Last Update Posted: 2020-07-31
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS)
• at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using US, CT or MRI
• signed informed consent

Exclusion Criteria

• congestive hepatopathies
• severe cardiovascular dysfunction
• no recent cross-sectional images within 4 weeks
• suboptimal cross-sectional images quality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cross-sectional image with CEUS	contrast enhanced ultrasound	The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS.

Primary Outcome Measures

Name	Time	Method
Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.	1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.	Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.
Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation	1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.	Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.

Secondary Outcome Measures

Name	Time	Method
Comparing image characters between two types of ultrasound contrast media	For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.	Comparing image characters between two types of ultrasound contrast media

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of