Clinical trial NCT02969603: Evaluation of Leg Muscular Activity Using MRI and 11C-acetate PET/MRI. Pilot Study
Official title: Evaluation of Leg Muscular Activity Using Magnetic Resonance Imaging and 11C-acetate Positron Tomography (PET/MRI). Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: PET/MRI
muscular activity
11C-acetate
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The present study is conceived as a pilot study aimed to determine the efficiency of the newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid scan technique for muscular activity evaluation, creation of anatomic images of muscle activity and resolution of metabolic activity distribution within exercising skeletal muscle.


Eligibility criteria: Inclusion Criteria:

MRI exam inclusion criteria

* Male volunteer aged in the range 18 to 35 years.
* Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.
* Volunteers that could undergo 1h15 to 1h30 immobilization (MRI exam duration in time).

PET/MRI exam inclusion criteria

* Male volunteer aged in the range 18 to 35 years.
* Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.
* Volunteers that could undergo 1.5 to 2.0 hours immobilization (PET/MRI exam duration in time).
* Volunteers should practice regular physical activity, defined as 50 min per day (in a single session), 2 days per week of physical activity as a minimum (no maximum is fixed).

Exclusion criteria MRI exam exclusion criteria

* Pre-existing neurological or muscular lesions on the legs.
* Co morbidities impeding on the protocol comprehension or fulfilment.
* Illnesses that do not allow to lay down on an examination table.
* Pacemaker holder.
* Metal implants that would preclude MRI imaging
* Claustrophobia: Subjects will be questioned about possible discomfort with being in an enclosed space (e.g., MRI scanner). Those who report such problems will be excluded.

PET/MRI exam exclusion criteria

* Medical radiation exposure within the last five years (normal population should not be exposed to medical radiation higher or equal to 1 mSv per year).
* Pre-existing neurological or muscular lesions on the legs.
* Co morbidities impeding on the protocol comprehension or fulfilment.
* Illnesses that do not allow to lay down on an examination table.
* Pacemaker holder.
* Metal implants that would preclude MRI imaging
* Claustrophobia: Subjects will be questioned about possible discomfort with being in an enclosed space (e.g., MRI scanner). Those who report such problems will be excluded.

Primary outcomes:
measure: Assessment of musculoskeletal systems in motion
timeFrame: though study completion, an average of 2 years
measure: Distribution of acetate metabolism during exercise skeletal muscle
timeFrame: though study completion, an average of 2 years
Secondary outcomes:
measure: Measurement of the in vivo function of the muscle
timeFrame: though study completion, an average of 2 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Service de Medecine Nucléaire et Imagerie moléculaire- HUG
Study officials:
affiliation: University Hospital, Geneva
name: Osman Ratib, Pr.
role: PRINCIPAL_INVESTIGATOR
References: