Evaluation of Leg Muscular Activity Using Magnetic Resonance Imaging and 11C-acetate Positron Tomography (PET/MRI). Pilot Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment of musculoskeletal systems in motion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Assessment of musculoskeletal systems in motion
时间窗: though study completion, an average of 2 years
an informatic visualization tool of muscles implied in leg flexion/extension combining PET and MR infomation
Distribution of acetate metabolism during exercise skeletal muscle
时间窗: 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
次要结局
- Measurement of the in vivo function of the muscle(though study completion, an average of 2 years)
研究者
Osman Ratib
Dr.
University Hospital, Geneva