Goal of this study is to determine if high-field sodium-MRI can be used as:1) a sensitive, in vivo, and non-invasive biomarker to diagnose OA in an early stage and 2) as a method to follow the progression of OA and to monitor the effect of new…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) A curve that describes normal sodium concentration in knee cartilage over a
broad age range. This curve a a normal curve that can be used to detect early
OA using sodium-MRI.
2) Fundamental insight into the mechanism of OA and cartilage degeneration by
comparing sodium concentrations in cartilage in different pools (bound to PG
and free in solution).
3) Development of a gold standard for sodium concentration measurements in vivo
in cartilage by comparing sodium-MRI with ex vivo concentration measurements of
post-surgery obtained cartilage.
Secondary outcome
If the primary outcomes are of sufficient quality then these techniques can be
used for the development of new OA treatments.
Background summary
Osteoarthritis (OA) is a prevalent and disabling disease of the cartilage of
the articular joints. Reliable indicators do not exist to diagnose or monitor
changes of OA.
Furthermore, there is no therapy available to cure OA or to slow the
progression of the disease.
The gold standard at this moment is the radiograph that can show OA, however
this is at a late
stage of the disease where the damage to the cartilage is irreversible.
Reliable biomarkers are necessary
for fundamental OA research and for the development and monitoring the effect
of new treatments.
A strong candidate biomarker is sodium magnetic resonance imaging (MRI). Sodium
is a building block of cartilage and is strongly linked to proteoglycan (PG)
structures that determine the quality of cartilage. Changes in PG and
subsequent "swelling" of cartilage are indicators of early OA. Using the
high-field 7T MRI of the C.J. Gorter centre in the Radiology Department of the
LUMC we can measure the sodium signal of cartilage in vivo.
Study objective
Goal of this study is to determine if high-field sodium-MRI can be used as:
1) a sensitive, in vivo, and non-invasive biomarker to diagnose OA in an early
stage and 2) as a method to follow the progression of OA and to monitor the
effect of new treatments.
Study design
This research is a feasibility study to determine the possibility to use in
vivo sodium-MRI of articular cartilage as a biomarker of OA and cartilage
quality. The study was funded by the Dutch Reumafonds and is a
"serendipity-project", indicating that is is a pilot study for which not much
experimental work has been done but for which a theoretical basis exists.
The cartilage of patients who are undergoing knee prosthesis surgery due to OA
will be analyzed with a biohistochemical sodium analysis such that pre-surgery
sodium-MRI can be compared with post-operative ex vivo sodium concentration. By
doing so, sodium-MRI can be directly related to a gold standard.
In addition to the patients a series of healthy volunteers (i.e. OA
symptom-free) will be scanned using the same imaging protocol to determine a
normal curve of sodium concentration in relation to age. Early detection of OA
could be possible by comparing suspected patients to this curve.
Study burden and risks
Study participants will be in the 7T MRI scanner for a maximum duration of 60
minutes. After 30 minutes the knee coil will be placed around the other knee.
The risk of this study is equal to the normal, low, risk of 7T MRI. It is
important that the participants are screened for contra-indications for 7T MRI.
There is no contrast agent administered, the participants have to tasks to
perform other than to move as little as possible during scanning. The
participant can listen to music during scanning.
Einthovenweg 20
Leiden 2333 ZC
NL
Einthovenweg 20
Leiden 2333 ZC
NL
Listed location countries
Age
Inclusion criteria
Patients: people who are selected for knee joint replacement
Age-matched controls: people who are OA symptom free
Healthy volunteers: people who are OA symptom free
Exclusion criteria
Contra-indications for 7T MRI scanning
No consent
No family
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL45506.058.13 |