CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 121 enrolled
Drug / intervention
Diffusion-weighted magnetic resonance imaging (DW-MRI)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02682108
NCT02682108N/ACompleted

Diffusion-weighted Imaging Magnetic Resonance for Assessing Liver Fibrosis in Patients With Chronic Viral Hepatitis

Mahidol University·interventional·Posted Feb 15, 2016·Updated Sep 14, 2016

In Brief

A clinical study evaluating Diffusion-weighted magnetic resonance imaging (DW-MRI) for Fibrosis, Liver. Completed, enrolled 121 participants across 1 site.

Detailed Summary

Several noninvasive radiological techniques have been investigated for the diagnosis of liver fibrosis and cirrhosis among patients with chronic infection with hepatitis B virus or hepatitis C virus. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a particularly appealing method for the diagnosis of liver fibrosis. The aims of this study are to evaluate the accuracy of DW-MRI in patients with chronic viral hepatitis for determining the stage of liver fibrosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibrosis, Liver
CountriesThailand
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2016
Enrollment StartApr 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.4 years ago

Interventions

Diffusion-weighted magnetic resonance imaging (DW-MRI)device

Magnetic resonance (MR) imaging examination of liver will be performed on a 3.0T Achieva MR scanner (Philips Medical Systems, The Netherlands). Diffusion-weighted imaging (DWI) will be performed using a single-shot echo-planar imaging during a single end expiratory breath-hold. A single observer placed circular regions of interest around 2.30 cm2 to measure mean signal intensity (SI) in the right hepatic lobe and the spleen for each b value, avoiding areas of artifact, vessels, and focal lesions. A monoexponential fit will be performed to calculate liver and spleen apparent diffusion coefficient (ADC) on the basis of ln(SI) as a function of b value, using all b values. Normalized liver ADC will be calculated as the ratio of liver ADC to spleen ADC.