CClinicalTrials.gg
Status unknownNCT03456440Updated Mar 7, 2018

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

An observational study in Hepatitis C, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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].

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • hepatitis C child pugh's class A

    patients are examined with MRI

    Diagnostic Test: MRI

  • normal individuals

    controls cases are examined with MRI

    Diagnostic Test: MRI

Interventions

  • Diagnostic testMRI

    MRI scan of the patients liver with DWI and acquisition of ADC value.

05

What researchers measure

Primary outcomes

  1. changes of MRI ADC value to assess early liver cirrhosis.

    Hepatitis C patients With child pugh's classification A as Assessed by MRI ADC value changes.

    Time frame: 30 minutes

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03456440
Lead sponsor
Assiut University
Responsible party
Jimmy Naaman (principal investigator, Assiut University) — Principal investigator
First posted
Mar 7, 2018
Start date
Apr 2019 (estimated)
Primary completion
Mar 2020 (estimated)
Completion
May 2020 (estimated)
Last update
Mar 7, 2018

Study contacts

magdy adel, MBBBCh
Contact
j_no3man@hotmail.com
01147850388
sherif abd elal, MD
study director · Assiut university lecturer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion