Our primary goal is to develop and validate a Juvenile Arthritis MRI Score (JAMRIS) for the ankle. Secondly, to evaluate the individual and interdependent value of optimized 3.0 Tesla magnetic resonance imaging (MRI) and ultrasound (US) for the…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To develop and validate a Juvenile Arthritis MRI Score (JAMRIS) for the ankle.
- To develop and validate a US imaging protocol specified for the ankle
affected by JIA
Secondary outcome
- To evaluate the accuracy, validity, correlation, predictive value and
responsiveness to change of optimized 3.0T MR imaging and ultrasound for the
evaluation of disease activity in the ankle of patients with JIA, compared to
the clinical examination as the reference standard.
- To evaluate the differences and similarities of US and optimized 3.0T MRI
between three clinical subgroups, defined as clinically active, inactive or
remitting (see also under 4.1).
- To assess the diagnostic accuracy of DWI in the evaluation of disease
activity (synovitis) in JIA as compared to contrast-enhanced MRI as the
reference standard.
- To assess the diagnostic accuracy of UTE in the evaluation of tendinopathy
compared to contrast-enhanced MRI as the reference standard.
(researchprotocol pages 11, 12 &18)
Background summary
The ankle is the second most affected joint in children suffering of juvenile
idiopathic arthritis (JIA). Involvement of the ankle joint in the disease
process is associated with a less favorable outcome. Foot function can be well
preserved when optimally treated. Accurate and objective assessment of disease
activity in the ankle is therefore of great importance.
Study objective
Our primary goal is to develop and validate a Juvenile Arthritis MRI Score
(JAMRIS) for the ankle. Secondly, to evaluate the individual and interdependent
value of optimized 3.0 Tesla magnetic resonance imaging (MRI) and ultrasound
(US) for the evaluation of disease activity in the ankle of patients with, or
suspected for having JIA, compared to the clinical assessment and a selection
of blood biomarkers.
Study design
Prospective study
Study burden and risks
In addition to current clinical care - which includes physical examination,
blood sampling, conventional radiography and MRI * an ultrasound is scheduled
on the same day as the MRI and is therefore minimally invasive. The risks
associated with participation in this study are negligible.
meibergdreef 9
Amsterdam 1105AZ
NL
meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
* Clinically (suspected) active JIA with ankle involvement OR clinically
inactive JIA / JIA patients in remission with ankle involvement attributed to
JIA in the past
* Scheduled to undergo MRI of the ankle
* Written informed patients (when >12 years of age) and written informed
parental consent.
The parental consent of patients older than 16 years of age will become
obsolete when the proposed amendment to the Medical Research Involving Human
Subjects Act (WMO), which lowers the age limit of parental consent to 16 years,
is adopted.
Exclusion criteria
* Age <8 and *18 years.
* A history of intra-articular corticosteroids injection within the last 6
months.
* The need for anesthesia during the MRI examination.
* General contraindications for MRI (such as renal insufficiency, pregnancy and
claustrophobia).
* Lack of written informed consent.
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 | NL58057.018.16 |