Role of CEUS as a Secondary Diagnostic Modality
Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma
Lead Sponsor: Seoul National University Hospital
|Source||Seoul National University Hospital|
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.
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.
|Start Date||June 8, 2020|
|Completion Date||December 31, 2021|
|Primary Completion Date||June 30, 2021|
Intervention Type: Diagnostic Test
Intervention Name: contrast enhanced ultrasound
Description: Perflubutane enhanced ultrasound for evaluating hepatic tumor
Arm Group Label: Cross-sectional image with CEUS
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
- 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
- congestive hepatopathies
- severe cardiovascular dysfunction
- no recent cross-sectional images within 4 weeks
- suboptimal cross-sectional images quality
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: Accepts Healthy Volunteers
Last Name: Hyo-Jin Kang, M.D.
Email: [email protected]
Korea, Republic of
Type: Principal Investigator
Investigator Affiliation: Seoul National University Hospital
Investigator Full Name: Jeong Min Lee
Investigator Title: Pf.
|Has Expanded Access||No|
|Number Of Arms||2|
Label: Cross-sectional image only
Type: No Intervention
Description: Image set which consists of a Cross-sectional image only.
Label: Cross-sectional image with CEUS
Type: Active Comparator
Description: The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS.
|Study Design Info||
Intervention Model: Parallel Assignment
Intervention Model Description: All participants underwent CEUS. The image reviews based on cross-section images will be performed with or without CEUS results. Two image sets (cross-sectional image with CEUS and without CEUS) will be compared.
Primary Purpose: Diagnostic
Masking: Single (Outcomes Assessor)