Chronic Hepatitis, Liver Cirrhosis
Conditions
Keywords
HBsAg(+) with chronic hepatitis or cirrhosis, anti-HCV(+) with cirrhosis, cirrhosis of any etiology
Brief summary
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.
Interventions
OTHERhepatocyte-specific contrast agent, extracellular contrast agent
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).
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | an expected average of 2 weeks | 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. |
| Specificity | an expected average of 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-reader agreement between two radiologists | an expected average of 2 weeks | 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. |
Countries
South Korea
Outcome results
None listed