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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03892681
• Other study ID #: 4-2018-1047
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 129
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Chronic Hepatitis
• Fibrosis
• Hepatitis
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Other:
• hepatocyte-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).

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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 ? coefficient.	an expected average of 2 weeks