To evaluate the reproducibility of DCE-MRI measurement of the joints analyzed by color coded shape mapping, and by compartmental model analysis.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Synovial and bursal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
DCE-MRI scans obtained at the two time points will be scored according to the
omeract RAMRIS score by DCE-MR color coded shape mapping and by compartmental
analysis (quantitative analysis) (appendix B).
Correlation between the two time points will be evaluated by the Spearman*s
rank correlation coefficient. In addition the change in mean, within patient
standard deviation, within patient coefficient of variation and the
repeatability will be determined.
Differences between healthy individuals and arthritis patients will be
evaluated to determine the basal level of enhancement
Secondary outcome
not applicable
Background summary
Magnetic Resonance Imaging (MRI) is a powerful technique that can be used to
visualize and investigate the earliest changes in the joints of RA patients.
Synovitis is best viewed using pre-and post gadolinium (Gd DPTA) sequences, and
can be quantified by static conventional MRI scans or by Dynamic Contrast
Enhanced MRI scans (DCE-MRI).
DCE-MRI involves the dynamic sampling of the MR-signal during intravenous
injection of the contrast agent (gd DPTA). Three methods are developed to
evaluate tissue changes using the curves obtained with DCE-MRI. Each of these
three methods has its drawbacks.
Because of the drawbacks, a new DCE-MR analysis and imaging method has been
developed, using a 3D pixel by pixel method to visualize shape curve
distribution within the joint. In this study the reproducibility of the new
method will be evaluated.
Study objective
To evaluate the reproducibility of DCE-MRI measurement of the joints analyzed
by color coded shape mapping, and by compartmental model analysis.
Study design
Reproducibility of DCE-MRI will be evaluated by comparing MR analysis results
obtained at 2 different time points from the joint of the same patient or
healthy control. In addition parameters of disease activity, vital parameter,
medical history and medication use will be recorded before each MRI.
Study burden and risks
Patients will undergo a contrast enhanced MRI of a knee joint twice. There are
no known interactions of the contrast agent and any drugs. Patients can get an
allergic reaction to the contrast agent but these reactions are rare.
Participation takes 120 minutes in total.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
RA-patients: artritis of a knee joint
Healthy volunteers: none
Exclusion criteria
RA-patients : claustrofobia, known allergy to gadolineum contrast agent
Healty volunteers: 1)history of joint disease 2)claustrofobia, known allergy to gadolineum contrast agent
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 | NL15726.018.07 |