Evaluation of Leg Muscular Activity Using MRI and 11C-acetate PET/MRI. Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Leg Muscular Activity Using Magnetic Resonance Imaging and 11C-acetate Positron Tomography (PET/MRI). Pilot Study

Conditions
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Healthy

Intervention / Treatment
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* Other: Magnetic Resonance Imaging
* Other: Magnetic Resonance combined with Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers- MRI<br>MRI scan for morphological assessment of muscle structures and anatomy | Other: Magnetic Resonance Imaging<br>* Magnetic Resonance Imaging as reference<br>|
| Other: Healthy Volunteers- PET/MRI<br>The volunteers will undergo a combined [11C]acetate PET/MRI scan | Other: Magnetic Resonance combined with Positron Emission Tomography<br>* Comparison with MRI only, to assess muscular activity, creation of anatomic images of muscle activity and resolution of metabolic activity distribution within exercising skeletal muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of musculoskeletal systems in motion | an informatic visualization tool of muscles implied in leg flexion/extension combining PET and MR infomation | though study completion, an average of 2 years | 
| Distribution of acetate metabolism during exercise skeletal muscle | 11C-acetate uptake (SUV and SUVratio with resting muscles) in contracting muscle, measured using muscle segmentation from MRI images | though study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the in vivo function of the muscle | correlation between 11C-acetate uptake and contractile force measures (weight and duration of exercise) | though study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/MRI, muscular activity, 11C-acetate