Hepatitis CNCT03456440
The Use of MRI Apparent Diffusion Coefficient Value (ADC Value) to Assess Liver Cirrhosis
An observational study of Hepatitis C, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- MRI
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from outpatient clinic of radiology department of Assiut university hospital.
Who may be able to join
- Hepatitis C positive patients with Child-Pugh (A) classification.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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].
- Conditions
- Hepatitis C
- Being tested
- MRI
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI scan of the patients liver with DWI and acquisition of ADC value.
| Study group | Role | What they receive |
|---|---|---|
| hepatitis C child pugh's class A | patients are examined with MRI Receives: Diagnostic Test: MRI | |
| normal individuals | controls cases are examined with MRI Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study startApr 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimmy Naaman, Assiut University
- Investigators
- sherif abd elal, MD, Study director, Assiut university lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456440
- Sponsor's protocol ID
- ADC value and cirrhotic liver
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of MRI Apparent Diffusion Coefficient Value (ADC Value) to Assess Liver Cirrhosis in Hepatitis C Patients: Observational Case Control Study
- ClinicalTrials.gov ID
- NCT03456440
- Acronym / sponsor ID
- ADC value and cirrhotic liver
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatitis C child pugh's class A | – | Diagnostic Test: MRIpatients are examined with MRI |
| normal individuals | – | Diagnostic Test: MRIcontrols cases are examined with MRI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from outpatient clinic of radiology department of Assiut university hospital.
Key inclusion criteria (1 listed)
- Hepatitis C positive patients with Child-Pugh (A) classification.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI scan of the patients liver with DWI and acquisition of ADC value. | Diagnostic test | hepatitis C child pugh's class A, normal individuals |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sherif abd elal, MD study director
Assiut university lecturer
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact magdy adel, MBBBCh (01147850388, j_no3man@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of MRI ADC value to assess early liver cirrhosis. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.