Our objectives are to assess correlations and relationships between synovitis visualized on non-contrast DESS MRI and: 1) synovitis imaged on CE-MRI; 2) different inflammatory subtypes in OA; 3) other MRI features of OA; 4) knee OA symptoms and 5)…
ID
Source
Brief title
Condition
- Synovial and bursal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlations between synovitis visualized on non-contrast DESS and: 1) CE-MRI;
2) Tissue markers of synovial inflammation and specific inflammatory subtypes;
3) Other OA features on MRI; 4) knee OA symptoms and 5) (CE)US findings
related to synovitis.
Secondary outcome
1. Synovial Ttissue and synovial fluid markers of synovial inflammation and
specific inflammatory subtypes;
2. Other OA features on MRI, particularly compositional and morphological
change in cartilage and meniscus, altered blood perfusion in synovium and
subchondral bone, and osteophyte formation;
3. Knee OA symptoms, especially those related to synovitis (i.e. joint
stiffness, self-reported feeling of swelling, pain patterns (constant versus
intermittent pain)), recorded with validated standardized questionnaires (like
ICOAP, KOOS, VAS and WOMAC).
4. US findings related to synovitis
Background summary
As the prominent role of synovitis in osteoarthritis (OA) and importance of
identifying patients with synovitis for targeted treatment are increasingly
recognized, there is growing interest in imaging of synovitis in OA.
Contrast-enhanced magnetic resonance imaging (CE-MRI) is the reference standard
for visualizing synovitis, but incurs high costs, long scan time and potential
health issues in high-risk patients, associated with the contrast agent. A
promising recent innovation in MRI of synovitis is rapid diffusion weighted
imaging with dual echo steady state (DESS) without the need for a contrast
agent. We hypothesize that synovitis imaged with non-contrast DESS MRI shows
high correlation with 1) synovitis imaged on CE-MRI; 2) different inflammatory
subtypes in OA; 3) other MRI features of OA, 4) knee OA symptoms and 5)
synovitis imaged with contrast enhanced ultrasound (CEUS), which is another
option to visualize synovitis.
Study objective
Our objectives are to assess correlations and relationships between synovitis
visualized on non-contrast DESS MRI and: 1) synovitis imaged on CE-MRI; 2)
different inflammatory subtypes in OA; 3) other MRI features of OA; 4) knee OA
symptoms and 5) synovitis imaged with (CE)US.
Study design
Cross-sectional prospective observational study.
Study burden and risks
Two MRI sessions, each maximal 45 minutes, and exposure to acoustic noise. No
additional risk. No benefit for the patient. There is a very small risk for an
allergic reaction when MRI contrast agent is administered. In patients with
chronic severe kidney insufficiency (glomerular filtration rate (GFR) < 60
mL/min/1.73m2) the use of this contrast is contraindicated. In order to
diminish this risk, patients will be screened before inclusion. Thereby,
medication to counteract the reaction is present. The burden for the subject
will be minimal. Except drainig a vile of blood, administration of contrast
fluid, the burden will mainly exist of time for filling out a questionnaire,
undergoing a physical examination, cycling for 10 minutes on a home trainer and
MRI acquisition. There will be no direct benefits for the participants in this
study. All patients will receive the usual treatment form their treating
physician. The patient will also be subjected to an ultrasound examination of
the knee for a maximum of 15 minutes. During this session a microbubble
contrast, will be administered. For this session the burden for the subject
will be minimal. For the patients who will undergo knee surgery, synovial
tissue and synovial liquid will be collected during surgery. This is an
additional procedure during surgery, but with a relatively low burden.
During the MRI examination contrast fluid will be administered intravenously.
Therefore an intravenous catheter is placed before the MRI scanBy this
intravenous catheter a blood sample is taken for further tests. One vial will
be sufficient. The blood will be tested for example on biomarkers of
inflammation.
's Gravendijkwal 210
Rotterdam 3015 CE
NL
's Gravendijkwal 210
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Age * 18 years;
- Clinical signs of knee OA: knee pain (numeric rating scale > 3);
- Radiographic signs of knee osteoarthritis (radiographic Kellgren and Lawrence grade *1 );
- Signs of synovitis (i.e. joint effusion) on physical examination of the knee;
Exclusion criteria
- Subjects with a typical (e.g. metallic foreign bodies, etc.) contra-indication for an MRI exam;
- Renal insufficiency, checked with blood sample test (GFR < 60 ml/min/1,73 m²);
- Known allergy to contrast agents;
- Known pulmonary hypertension
- Woman who are pregnant or lactating
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 | NL57741.078.16 |