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

Study Overview
=================
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.

Official Title
-----------------
Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for HCC in Patients With Liver Cirrhosis

Conditions
-----------------
Cirrhosis, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Biannual ultrasonography
* Procedure: Annual noncontrast liver MRI
* Procedure: Contrast enhanced liver CT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LC group<br>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. | Procedure: Biannual ultrasonography<br>* Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.<br>Procedure: Annual noncontrast liver MRI<br>* 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.<br>Procedure: Contrast enhanced liver CT<br>* In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity for detecting HCC |  | 6 months after last patient's MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specificity for detecting HCC |  | 6 months after last patient's MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, HCC, surveillance