The Use of MRI Apparent Diffusion Coefficient Value (ADC Value) to Assess Liver Cirrhosis

March 2, 2018 updated by: Jimmy Naaman, Assiut University

The Use of MRI Apparent Diffusion Coefficient Value (ADC Value) to Assess Liver Cirrhosis in Hepatitis C Patients: Observational Case Control Study

Hepatitis is known to induce severe liver diseases. The evaluation of the severity of liver cirrhosis is very important for the selection of appropriate treatment plan and the monitoring of patient response to treatment, accurate staging of liver fibrosis is critical because it determines the indication of antiviral treatment and prognosis of patients with chronic viral hepatitis, DWI is a particularly appealing method for the diagnosis of liver fibrosis because it is easy to implement and process, without the need for contrast agents. Apparent diffusion coefficient (ADC) has been shown to be a promising marker of fibrosis and cirrhosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Introduction Hepatitis is known to induce severe liver diseases such as liver cirrhosis and liver cancer which are serious threats to public health. The evaluation of the severity of liver cirrhosis is very important for the selection of appropriate treatment plan and the monitoring of patient response to treatment [1].

Noninvasive Child-Pugh classification is a common method to assess liver function, treatment outcome and prognosis in patients with chronic liver cirrhosis [2].

Accurate staging of liver fibrosis (commonly determined by liver biopsy) is critical because it determines the indication of antiviral treatment and prognosis of patients with chronic viral hepatitis. For example, patients with cirrhosis are at higher risk of end-stage liver disease, portal hypertension, and hepatocellular carcinoma and are less likely to respond to antiviral therapy [8-9].

However, liver biopsy is relatively invasive, limited by sample size, and difficult to repeat. Thus, noninvasive tools to assess the degree of fibrosis of the whole liver are urgently needed. Several noninvasive MRI techniques have been investigated for the diagnosis of liver fibrosis and cirrhosis, including diffusion weighted imaging (DWI) [20-24], MR Elastography [25], and perfusion-weighted imaging [26-27].

DWI is a particularly appealing method for the diagnosis of liver fibrosis because it is easy to implement and process, without the need for contrast agents. Apparent diffusion coefficient (ADC) has been shown to be a promising marker of fibrosis and cirrhosis by several independent investigators [20-24].

Recently magnetic resonance Diffusion Weighted Imaging (DWI) has become another noninvasive approach to assess liver cirrhosis by analyzing the changes of water diffusion based on the apparent diffusion coefficient (ADC) [3].

Several studies showed that ADC values of cirrhotic liver were correlated with the results of Child-Pugh classification for the evaluation of the severity of liver cirrhosis [4-7].

However, whether ADC values of cirrhotic liver are correlated with the results of Child-Pugh classification, it remains unclear. The DWI is a specific MRI technique that evaluates the motion of, mainly, water protons in the tissue. The apparent diffusion coefficient (ADC) is the most frequently used DWI measure and provides useful information about inflammation, perfusion and local cell breakdown. The ADC map is calculated based on exponential fitting of DWI over multiple b-values and is used to measure diffusion quantitatively. Prior studies have shown that in liver fibrosis water diffusion may be diminished by extracellular collagen fibers and proteoglycans, thus, reduced ADC values have been reported for liver fibrosis. [10,11,12,13,14,15,16,17,18,20].

These findings suggest DWI could be a useful imaging technique to evaluate fibrosis. In more recent studies, researchers examined the relationship between the stages of hepatic fibrosis and ADC values [14,15,16,19,20].

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be recruited from outpatient clinic of radiology department of Assiut university hospital.

Description

Inclusion Criteria:

  • Hepatitis C positive patients with Child-Pugh (A) classification.

Exclusion Criteria:

  • Advanced liver cirrhosis with decompensated liver or patients with malignant hepatic focal lesions.
  • Cases with proven structural abnormalities, history of liver disease or risk factors of liver disease will be excluded from healthy controls.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hepatitis C child pugh's class A
patients are examined with MRI
MRI scan of the patients liver with DWI and acquisition of ADC value.
normal individuals
controls cases are examined with MRI
MRI scan of the patients liver with DWI and acquisition of ADC value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of MRI ADC value to assess early liver cirrhosis.
Time Frame: 30 minutes
Hepatitis C patients With child pugh's classification A as Assessed by MRI ADC value changes.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: sherif abd elal, MD, Assiut university lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (ACTUAL)

March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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