Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis
NCT ID: NCT03742453
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
117 participants
INTERVENTIONAL
2018-10-16
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Hepatic nodule group
This group meets eligibility criteria, and undergo contrast-enhanced ultrasound (CEUS) and scheduled gadoxetic acid MRI (gadoxetic acid-enhanced liver MRI; EOB-MRI; Gd-EOB-MRI)
contrast-enhanced ultrasound
CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.
EOB-MRI
EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.
Interventions
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contrast-enhanced ultrasound
CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.
EOB-MRI
EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT)
* newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year
* scheduled for gadoxetic acid-enhanced liver MRI
* signed informed consent
Exclusion Criteria
* pregnancy
* history of recent treatment for HCC in a year
* standard of reference is not available
* severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)
20 Years
ALL
No
Sponsors
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Bracco Corporate
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Jeong Min Lee
Professor
Principal Investigators
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Jeong Min Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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SNUH-2018-2268
Identifier Type: -
Identifier Source: org_study_id
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