Hepatocyte-specific Versus Extracellular Contrast Agents for Liver MRI: Prospective, Intra-individual Comparison of Diagnostic Performance for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Adult patients with chronic hepatitis B and cirrhosis of any etiology who are found to have suspected liver cancer are potentially eligible for the study. All enrolled patients will undergo two MRI scans using two different contrast agents. The type of contrast agent for the 1st MRI will be performed using hepatocyte-specific contrast agent. The participant will undergo the 2nd MRI using extracellular contrast agent. The MRI examinations will be independently interpreted by two different radiologists. The radiologists will evaluate focal hepatic lesions and categorize them according to the LI-RADS v2018 and EASL 2018. Once the diagnosis is made, the participants will be provided with the standard of care. After the initial treatment, the participants will be followed up with multi-phasic dynamic contrast-enhanced CT every 3 or 6 months for at least 2 years. Based on the prospectively written radiology reports, the diagnostic performances will be calculated and compared between MRI with hepatocyte-specific contrast agent and MRI with extracellular contrast agent, using the pathology and clinical criteria as the reference standard.

Official Title
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Hepatocyte-specific Versus Extracellular Contrast Agents for Liver MRI: Prospective, Intra-individual Comparison of Diagnostic Performance for Hepatocellular Carcinoma

Conditions
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Chronic Hepatitis, Liver Cirrhosis

Intervention / Treatment
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* Other: hepatocyte-specific contrast agent, extracellular contrast agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 20 years HBsAg (+) with chronic hepatitis or cirrhosis, anti-HCV (+) with cirrhosis, or cirrhosis of any etiology The presence of cirrhosis will be determined based on the histologic or radiologic findings, including liver surface nodularity, margin blunting, segmental hypertrophy/atrophy, and findings secondary to portal hypertension (i.e., splenomegaly, esophageal or gastric varices, ascites, or reverse portal vein flow). Child-Pugh class A or B Up to three suspicious focal lesions between 10 mm and 30 mm found on US, CT, or MRI Patients with a history of HCC treated by surgery or tumor ablation could be included, but only new nodules at a distance of > 2 cm from previously treated lesions were considered. Exclusion Criteria: Currently pregnant or lactating Risk group for the use of gadolinium-enhanced MRI including severely decreased renal function (stage 4 or 5 chronic renal failure with eGFR ˂ 30 mL/min/1.73 m2), claustrophobia Patients with history of chemoembolization or systemic treatment for liver cancer

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: contrast agents for liver MRI<br> | Other: hepatocyte-specific contrast agent, extracellular contrast agent<br>* The type of contrast agent for the 1st MRI will be performed using hepatocyte-specific contrast agent (Primovist). The participant will undergo the 2nd MRI using extracellular contrast agent (Gadovist).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The comparison of sensitivity between MRI using hepatocyte-specific contrast agent and extracellular contrast agent in the diagnosis of hepatocellular carcinoma The per-lesion sensitivity will be compared using McNemar's test. | an expected average of 2 weeks | 
| Specificity | The comparison of specificity between MRI using hepatocyte-specific contrast agent and extracellular contrast agent in the diagnosis of hepatocellular carcinoma. The per-lesion sensitivity will be compared using McNemar's test. | an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-reader agreement between two radiologists | The inter-reader agreement between two radiologists for the LI-RADS v2018 categorization and diagnosis of HCC according to EASL 2018 in each MRI using hepatocyte-specific contrast agent and extracellular contrast agent. The inter-reader agreement will be evaluated using Cohen κ coefficient. | an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBsAg(+) with chronic hepatitis or cirrhosis, anti-HCV(+) with cirrhosis, cirrhosis of any etiology