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

Seoul National University

Status: Unknown

Conditions: Cirrhosis; Hepatocellular Carcinoma

Treatments: Procedure: Annual noncontrast liver MRI; Procedure: Contrast enhanced liver CT; Procedure: Biannual ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02854241

SNUH-2016-0174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

LC group

Experimental group

Description:

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.

Treatment:

Procedure: Annual noncontrast liver MRI

Procedure: Contrast enhanced liver CT

Procedure: Biannual ultrasonography