Alternative Surveillance Program for Patients With High Risk Group of HCC

Study Overview
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Brief Summary
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In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared

Official Title
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Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: Non-contrast focused MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic hepatitis B or C Child-Pugh classification A HCC risk score >= -2.04 have not diagnosed with HCC on surveillance program using US and negative on previous US within 6-8 months of enrollment sign informed consent Exclusion Criteria: younger than 40 years or older than 70 years old history of HCC severe GFR or on HD/PD due to renal failure contra-indication of MRI congestive hepatopathy iron deposition pregnancy or nursing mother non-viral hepatitis or liver cirrhosis

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US & MRI<br>All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI. | Diagnostic Test: Non-contrast focused MRI<br>* non-contrast liver MRI focusing on HCC surveillance in a short scan time.<br>* Other names: Abbreviated MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection | per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer. | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of annual focused MRI and biannual US for HCC detection | per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer. | up to one year | 
| diagnostic yield for HCC | HCC incidence in the group and detection rate with either US or focused MRI | up to one year | 
| scan time of focused MRI | in room time, table time are manually recorded | up to one month | 
| comparison between false referral rates of biannual US and annual focused MRI | comparison between false positive report/finding for HCC in each surveillance modality. | up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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US, MRI, HCC, surveillance, risk estimation