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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02969603
• Other study ID #: 2013DR2115
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 14, 2016
• Last updated: November 16, 2016
• Start date: September 2013
• Est. completion date: December 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Magnetic Resonance Imaging
Magnetic Resonance Imaging as reference
• Magnetic Resonance combined with Positron Emission Tomography
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

Locations

Country	Name	City	State
Switzerland	Service de Medecine Nucléaire et Imagerie moléculaire- HUG	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Osman Ratib

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No