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

Primary Purpose

Chronic Hepatitis, Liver Cirrhosis

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

hepatocyte-specific contrast agent, extracellular contrast agent

About this trial

This is an interventional diagnostic trial for Chronic Hepatitis focused on measuring HBsAg(+) with chronic hepatitis or cirrhosis, anti-HCV(+) with cirrhosis, cirrhosis of any etiology

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

contrast agents for liver MRI

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03892681

First Posted

March 21, 2019

Last Updated

March 25, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03892681

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 2019 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis, Liver Cirrhosis

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

contrast agents for liver MRI

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

hepatocyte-specific contrast agent, extracellular contrast agent

Intervention Description

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).

Primary Outcome Measure Information:

Title

Sensitivity

Description

Time Frame

an expected average of 2 weeks

Title

Specificity

Description

Time Frame

an expected average of 2 weeks

Secondary Outcome Measure Information:

Title

Inter-reader agreement between two radiologists

Description

Time Frame

an expected average of 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Yonsei University College of Medicine

City

Seoul

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Myeong-Jin, Kim

Phone

82-2-2228-7400

kimnex@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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