To calculate the repeatability and reproducibility of MRE stiffness measurements in the liver on a voxel-by-voxel basis.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The voxel-wise variability in elasticity measurements for patients and healthy
volunteers for:
* Repeated measurements during one scanning session
* Same-day reproducibility
* Reproducibility with a 2-4 week interval
Secondary outcome
NA
Background summary
Magnetic Resonance Elastography (MRE) is a new non-invasive method to evaluate
liver fibrosis by measuring liver stiffness. A non-invasive tool for measureing
liver fiborosis is important as the current gold standard, liver biopsy, has
many drawbacks. It is invasive, has a risk of complications, is prone to
sampling errors and inter-observer variability of the pathologist. Due to these
drawbacks, liver biopsy cannot be used to monitor patients with chronic liver
diseases. To date, the findings of MRE have been studied in a wide spectrum of
chronic liver diseases and have shown to be promising. Reproducibility of
findings, however, have not been investigated much, and never for 3T MRI.
Investigating the precision of stiffness values measured is important when the
technique is to be used as a follow-up tool to evaluate treatment response or
disease progression.
Study objective
To calculate the repeatability and reproducibility of MRE stiffness
measurements in the liver on a voxel-by-voxel basis.
Study design
This is a single centre, observational study
Study burden and risks
Participating in this study leads to no immediate advantage for the individual
participant. However, it is important to evaluate the precision of this new MR
technique when it is to be used in clinical practise. Therefore in the future,
patients with chronic liver disease may benefit considerably by this new
diagnostic modality. All participants in this study will receive a financial
compensation of 75 euros for completing both MRI scans.
MR Elastography will be performed during two MRI sessions of approximately
30-40 minutes each. MR Elastography is a non-invasive, non ionizing examination
and has no physical burden, except that during scanning the patient will have
to lie still on his or her back. Patients will also have to hold their breaths
on expiration for 10 seconds each time. Patients can indicate when they are
ready for the next breath hold. From experience, patients do not find it hard
to follow and perform these instructions. The vibrations of the MRE transducer
are felt, but do not cause discomfort or pain. Each scanning session will
require an extra visit to the hospital. No oral or intravenous contrast medium
will be given to the patient. Patients are not delayed in treatment for their
disease. There will be little extra physical and psychological discomfort
associated with participation.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients:
**18 years of age
*Known chronic liver disease
*Not on treatment for liver disease during study period
*Written informed consent;Volunteers:
*No history of liver disease
*Written informed consent
Exclusion criteria
Patients/Volunteers:
*Under 18 years of age
*Contra-indications for MRI scanning (use of standard MRI checklist, see document E4)
*Treatment for liver disease
*Use of medications known to have steatogenic effects on the liver: synthetic estrogens, corticosteroids, diltiazem, nifedipine, perhexilline, amiodarone, metformine, insulin, statins, rosglitazon, methotrexate, antiretroviral therapy, tamoxifen, tetracycline, valproate*
*Known hemochromatosis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32598.018.10 |