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

Seoul National University Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Cirrhosis Hepatocellular Carcinoma

Interventions

Biannual ultrasonographyPROCEDURE

Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.

Annual noncontrast liver MRIPROCEDURE

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 CTPROCEDURE

In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

sensitivity for detecting HCC

Time frame: 6 months after last patient's MRI

Secondary Outcomes

specificity for detecting HCC

Time frame: 6 months after last patient's MRI

Data from ClinicalTrials.gov

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