Some control values for MR biomarkers of fatty infiltration and edema-like lesions in skeletal muscles of healthy volunteers - an explorative study

Patients with muscular dystrophy are characterized by progressive skeletal
muscle degeneration, edema-like lesions and replacement of muscle tissue by
fat. Together, this leads to progressive loss in muscle strength. In various
types of muscular dystrophy (e.g. facioscapulohumeral dystrophy (FSHD) and
Duchenne muscular dystrophy) it has been found that Magnetic Resonance Imaging
(MRI) can be very useful in the understanding of the disease as well as for
evaluation of treatments. Currently, a skeletal muscle MRI study is being
performed in patients with the muscular dystrophy disease Myotonic Dystrophy
type 1 (DM1). This skeletal muscle MRI study is performed within the
multicenter trial OPTIMISTIC where the effect of cognitive behavioural therapy
in patients with DM1 is investigated (NL nr: 46914.091.13). The two goals of
the skeletal muscle MRI study are to evaluate MRI biomarkers of fatty
infiltration and edema-like lesions 1) to get more insight in the disease
process and 2) to evaluate the possible effects of the cognitive behavioural
therapy. To be able to achieve these goals, it is important to investigate some
control values for these MRI biomarkers of fatty infiltration and edema-like
lesions. It is known that values of MRI biomarkers depend on the MRI scanner
and the scanning protocol, so they cannot be easily obtained from the
literature. Hence, to evaluate whether our findings in DM1 patients indeed
deviate from healthy people, we would like to obtain some control values by
scanning healthy volunteers.

To obtain some control values for the MRI biomarkers for fatty infiltration and
edema-like lesions in skeletal muscles of healthy volunteers.

Observational cross-sectional study whereby the volunteers undergo an MRI scan
the legs.

The proposed study is fully non-invasive and the added risk according to the
NFU document *Kwaliteitsborging mensgebonden onderzoek 2.0* is rated as
negligible. Therefore, the burden for the volunteers is relatively small. The
maximum duration of the MR experiment is 1 hour, which can be easily tolerated
by healthy subjects.