NCT03456440

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

February 23, 2018

Last Update Submit

March 2, 2018

Conditions

Outcome Measures

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.

    30 minutes

Study Arms (2)

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

MRIDIAGNOSTIC_TEST

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

hepatitis C child pugh's class Anormal individuals

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • sherif abd elal, MD

    Assiut university lecturer

    STUDY DIRECTOR

Central Study Contacts

magdy adel, MBBBCh

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 7, 2018

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

March 7, 2018

Record last verified: 2018-03