Abbreviated MRI for HCC Surveillance

Study Overview
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Brief Summary
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This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group.

Official Title
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MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group

Conditions
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Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis

Intervention / Treatment
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* Diagnostic Test: Biannual ultrasonography
* Diagnostic Test: Annual abbreviated liver MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: high risk of HCC development (chronic hepatitis B, chronic hepatitis C, liver cirrhosis) no history of HCC on surveillance of HCC using ultrasonography sign informed consent Exclusion Criteria: history of HCC congestive hepatopathy iron deposition any absolute or relative contra-indication of contrast-enhanced MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High risk group of HCC<br>High risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI. | Diagnostic Test: Biannual ultrasonography<br>* Biannual liver ultrasonography for HCC surveillance, without contrast agent.<br>* Other names: liver USG;Diagnostic Test: Annual abbreviated liver MRI<br>* Abbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes.<br>* Other names: Abbreviated liver MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for detecting HCC | Sensitivity for detecting HCC | 12 months after last MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Table time of abbreviated MRI | time from scan start and scan end | 1 day after each MRI | 
| In-room time of abbreviated MRI | interval between participants' walk-in and walk-out times | 1 day after each MRI | 
| Specificity for detecting HCC | Specificity for detecting HCC | 12 months after last MRI | 
| Sensitivity for detecting early stage HCC | Sensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor) | 12 months after last MRI | 
| Specificity for detecting early stage HCC | Specificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor) | 12 months after last MRI | 
| Image quality of abbreviated liver MRI | qualitative analysis on four-point scale | 12 months after last MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, ultrasonography