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

• ClinicalTrials.gov Identifier: NCT03892681
• Recruitment Status: Not yet recruiting
• First Posted: March 27, 2019
• Last Update Posted: March 27, 2019
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Hepatitis; Liver Cirrhosis	Other: hepatocyte-specific contrast agent, extracellular contrast agent	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 129 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Hepatocyte-specific Versus Extracellular Contrast Agents for Liver MRI: Prospective, Intra-individual Comparison of Diagnostic Performance for Hepatocellular Carcinoma
• Estimated Study Start Date: April 2019
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
contrast agents for liver MRI	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).

Outcome Measures

Primary Outcome Measures :

1. Sensitivity [ Time Frame: 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.
2. Specificity [ Time Frame: 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 Outcome Measures :

1. Inter-reader agreement between two radiologists [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Yonsei University College of Medicine; Not yet recruiting

Seoul, Korea, Republic of

Contact: Myeong-Jin , Kim 82-2-2228-7400 kimnex@yuhs.ac

Sponsors and Collaborators

Yonsei University

More Information

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT03892681 History of Changes
• Other Study ID Numbers: 4-2018-1047
• First Posted: March 27, 2019
• Last Update Posted: March 27, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:

HBsAg(+) with chronic hepatitis or cirrhosis; anti-HCV(+) with cirrhosis; cirrhosis of any etiology

Additional relevant MeSH terms:

Carcinoma, Hepatocellular; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Pathologic Processes