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

Yonsei University129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

129

Conditions

Chronic Hepatitis Liver Cirrhosis

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Older than 20 years 2. 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). 3. Child-Pugh class A or B 4. 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: 1. Currently pregnant or lactating 2. 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 3. Patients with history of chemoembolization or systemic treatment for liver cancer

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: an expected average of 2 weeks

Secondary Outcomes

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.

Time frame: an expected average of 2 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes