Role of CEUS as a Secondary Diagnostic Modality

Hepatocellular Carcinoma Clinical Trial

Official title:

Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04494022
• Other study ID #: 2004-035-1116
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: Hyo-Jin Kang, M.D.
• Phone: 82220723107
• Email: dr.kanghj[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• contrast enhanced ultrasound
Perflubutane enhanced ultrasound for evaluating hepatic tumor

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation	Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.	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.
Primary	Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.	Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or 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.
Secondary	Comparing image characters between two types of ultrasound contrast media	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.