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

November 16, 2016 updated by: Osman Ratib

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Service de Medecine Nucléaire et Imagerie moléculaire- HUG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy volunteers- MRI
MRI scan for morphological assessment of muscle structures and anatomy
Other: Magnetic Resonance Imaging
Magnetic Resonance Imaging as reference
Other: Healthy Volunteers- PET/MRI
The volunteers will undergo a combined [11C]acetate PET/MRI scan
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of musculoskeletal systems in motion
Time Frame: though study completion, an average of 2 years
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
Time Frame: 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
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
Time Frame: though study completion, an average of 2 years
correlation between 11C-acetate uptake and contractile force measures (weight and duration of exercise)
though study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osman Ratib

Investigators

  • Principal Investigator: Osman Ratib, Pr., University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013DR2115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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