Role of CEUS as a Secondary Diagnostic Modality
July 27, 2020 updated by: Jeong Min Lee, Seoul National University Hospital
Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Cross-sectional image only
Image set which consists of a Cross-sectional image only.
|
|
|
Active Comparator: Cross-sectional image with CEUS
The same participants with Arm1.
But image set will consist of a Cross-sectional image and CEUS.
|
Perflubutane enhanced ultrasound for evaluating hepatic tumor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation
Time Frame: 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.
|
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 diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparing image characters between two types of ultrasound contrast media
Time Frame: 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
|
For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jeong Min Lee, M.D., Seoul National University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 8, 2020
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
June 5, 2020
First Submitted That Met QC Criteria
July 27, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Actual)
July 31, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-035-1116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Time Frame
For two years after publication.
IPD Sharing Access Criteria
except you want to use illegal purpose
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.