Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance

Not Applicable

• Conditions: Cirrhosis; Hepatocellular Carcinoma
• Interventions: Procedure: Biannual ultrasonography; Procedure: Annual noncontrast liver MRI; Procedure: Contrast enhanced liver CT

• Registration Number: NCT02854241
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.

Detailed Description

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-31
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• equal to or older than 40 years
• 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

• under 40 years
• history of HCC
• patients with pregnancy or nursing
• any contraindication of MRI
• any contraindication of CT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LC group	Annual noncontrast liver MRI	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.
LC group	Biannual ultrasonography	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.
LC group	Contrast enhanced liver CT	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.

Primary Outcome Measures

Name	Time	Method
sensitivity for detecting HCC	6 months after last patient's MRI

Secondary Outcome Measures

Name	Time	Method
specificity for detecting HCC	6 months after last patient's MRI

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of