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

O

Osman Ratib

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Healthy

Treatments

Other: Magnetic Resonance Imaging
Other: Magnetic Resonance combined with Positron Emission Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT02969603
2013DR2115

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Healthy volunteers- MRI
Other group
Description:
MRI scan for morphological assessment of muscle structures and anatomy
Treatment:
Other: Magnetic Resonance Imaging
Healthy Volunteers- PET/MRI
Other group
Description:
The volunteers will undergo a combined \[11C\]acetate PET/MRI scan
Treatment:
Other: Magnetic Resonance combined with Positron Emission Tomography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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