To investigate the accuracy and effectivity of a short non-invasive fluid-sensitive MRI to identify clinical arthritis in patients with recent onset hand(s) complaints.The purpose of the *amendment* is to investigate in patients with joint…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinically detectable arthritis (>=1 swollen hand joint) observed at physical
examination by the rheumatologist in relation to MRI-detected joint
inflammation.
With the portable MRI, joint inflammation imaged with the regular MRI is the
outcome measure (in addition to the presence of joint inflammation during
physical examination by the rheumatologist).
Secondary outcome
na
Background summary
Early detection of arthritis followed by early treatment is essential to
improve the outcome of rheumatoid arthritis (RA)-patients and is the key of
international guidelines for early arthritis. In practice however early
recognition of arthritis is difficult. In the Netherlands, the majority of the
delay is located at general practitioners (GPs). The gold standard for
arthritis recognition is palpation of joint swelling at joint examination. At
small joints arthritis is often subtle and GPs feel inexperienced in joint
examination. To reduce referral delay and promote early recognition of
arthritis, we initiated the Early Arthritis Recognition Clinic (EARC) in 2010.
Although this is very effective in improving early recognition of arthritis,
this initiative is (inter)nationally not widely implemented, presumably due to
lack of rheumatologists/time. It would be more implementable if the joint
examination by the rheumatologist could be replaced with an accurate device.
The last 10 years the departments of rheumatology & radiology have studied the
value of MRI and shown that MRI is highly reproducible, sensitive, and
specific. However its use is limited by its costs, need of contrast-enhancement
and low accessibility due to the long scan protocol (~1 hour). Recently we have
developed a short fluid-sensitive MRI protocol (scan time <5 min) that does not
require contrast enhancement. This would make MRI patient-friendly,
non-invasive, quick, and cheaper for early detection of arthritis. If accurate,
it would allow implementation of MRI in clinical practice.
This short scan is made on the regularly used 3T scanners in the radiology
department. These scanners are expensive (¤20 million) and heavy (2K kg) and
are therefore only in hospitals. It is even more practical if a small portable
MRI scan, specially developed for the hand, can be kept at/near the GP. Prof.
Webb and his group at the LUMC have recently developed a portable brain scan
that is considerably cheaper and lighter (costs ¤ 15,000, weight 60 kg). Hands
can also be depicted with this. In an amendment we want to answer an additional
research question, whether this portable scan can display joint inflammations
as well as the "normal MRI". This analysis represents a first step in a
trajectory that is aimed at developing an accurate MRI scanner that is
practical for early recognition of arthritis in primary care.
Study objective
To investigate the accuracy and effectivity of a short non-invasive
fluid-sensitive MRI to identify clinical arthritis in patients with recent
onset hand(s) complaints.
The purpose of the *amendment* is to investigate in patients with joint
inflammation whether the portable MRI can visualize this inflammation as well
as the regular MRI.
Study design
This is a cross-sectional observational study.
Study burden and risks
In regular care the EARC comprises a short questionnaire and physical
examination by the rheumatologist. In this study patients will also have an
MRI-scan of the hands; this is a short protocol (<5 min) without contrast
enhancement. Ideally this scan is made the same day, or alternatively within
the same week. In case the MRI-scan is not scheduled the same day, an extra
visit is necessary, which cost the patient more time. Patients will have no
benefits when participating in this study. MRI will be scored blinded to
clinical data. MRI results will not be communicated to rheumatologists or
patients.
The portable MRI can be performed on the same day and the same hospital visit
as the regular MRI. The portable MRI has a very low field strength, so there
are no risks involved. People sit on a chair next to the scan and put their
hand in the MRI scanner during the scan. This scan is also performed blind to
clinical data or imaging data obtained at the regular scan.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Patients in whom GPs are uncertain of the presence of suspected arthritis and
are referred to the EARC.
- Age >=18 years.
- Hand(s) complaints.
- Ability and willingness to give written informed consent and to comply with
the requirements of the study protocol.
Exclusion criteria
- Contra indications for MRI: certain metal implants, pacemakers, pregnancy.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL75673.058.20 |