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

Phase 1

• Conditions: Healthy

• Registration Number: NCT02969603
• Lead Sponsor: Osman Ratib

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2016-04-14
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-16
• Last Update Submitted: 2016-11-16
• Study First Posted: 2016-11-21
• Last Update Posted: 2016-11-21
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service de Medecine Nucléaire et Imagerie moléculaire- HUG; 🇨🇭 Geneva, Switzerland