Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance
NCT ID: NCT02854241
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
40 participants
INTERVENTIONAL
2016-07-01
2022-06-30
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
SCREENING
NONE
Study Groups
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LC group
LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC.
Biannual ultrasonography
Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.
Annual noncontrast liver MRI
Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map.
DWI using multishot and T2 map are not included for initial MR reading.
Contrast enhanced liver CT
In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.
Interventions
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Biannual ultrasonography
Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.
Annual noncontrast liver MRI
Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map.
DWI using multishot and T2 map are not included for initial MR reading.
Contrast enhanced liver CT
In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.
Eligibility Criteria
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Inclusion Criteria
* under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
* risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
* signed informed consent
Exclusion Criteria
* history of HCC
* patients with pregnancy or nursing
* any contraindication of MRI
* any contraindication of CT
40 Years
ALL
No
Sponsors
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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-2016-0174
Identifier Type: -
Identifier Source: org_study_id
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