ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03456440
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jimmy Naaman, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatitis C Diagnostic Test: MRI

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
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Use of MRI Apparent Diffusion Coefficient Value (ADC Value) to Assess Liver Cirrhosis in Hepatitis C Patients: Observational Case Control Study
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
hepatitis C child pugh's class A
patients are examined with MRI
Diagnostic Test: MRI
MRI scan of the patients liver with DWI and acquisition of ADC value.

normal individuals
controls cases are examined with MRI
Diagnostic Test: MRI
MRI scan of the patients liver with DWI and acquisition of ADC value.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be recruited from outpatient clinic of radiology department of Assiut university hospital.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456440


Contacts
Contact: magdy adel, MBBBCh 01147850388 j_no3man@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
Study Director: sherif abd elal, MD Assiut university lecturer

Responsible Party: Jimmy Naaman, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03456440     History of Changes
Other Study ID Numbers: ADC value and cirrhotic liver
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections