<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02969603</url>
  </required_header>
  <id_info>
    <org_study_id>2013DR2115</org_study_id>
    <nct_id>NCT02969603</nct_id>
  </id_info>
  <brief_title>Evaluation of Leg Muscular Activity Using MRI and 11C-acetate PET/MRI. Pilot Study</brief_title>
  <official_title>Evaluation of Leg Muscular Activity Using Magnetic Resonance Imaging and 11C-acetate Positron Tomography (PET/MRI). Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osman Ratib</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study is conceived as a pilot study aimed to determine the efficiency of the&#xD;
      newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid&#xD;
      scan technique for muscular activity evaluation, creation of anatomic images of muscle&#xD;
      activity and resolution of metabolic activity distribution within exercising skeletal muscle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of musculoskeletal systems in motion</measure>
    <time_frame>though study completion, an average of 2 years</time_frame>
    <description>an informatic visualization tool of muscles implied in leg flexion/extension combining PET and MR infomation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution of acetate metabolism during exercise skeletal muscle</measure>
    <time_frame>though study completion, an average of 2 years</time_frame>
    <description>11C-acetate uptake (SUV and SUVratio with resting muscles) in contracting muscle, measured using muscle segmentation from MRI images</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of the in vivo function of the muscle</measure>
    <time_frame>though study completion, an average of 2 years</time_frame>
    <description>correlation between 11C-acetate uptake and contractile force measures (weight and duration of exercise)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers- MRI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>MRI scan for morphological assessment of muscle structures and anatomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers- PET/MRI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The volunteers will undergo a combined [11C]acetate PET/MRI scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Magnetic Resonance Imaging as reference</description>
    <arm_group_label>Healthy volunteers- MRI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance combined with Positron Emission Tomography</intervention_name>
    <description>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</description>
    <arm_group_label>Healthy Volunteers- PET/MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        MRI exam inclusion criteria&#xD;
&#xD;
          -  Male volunteer aged in the range 18 to 35 years.&#xD;
&#xD;
          -  Acceptance of the research protocol: signature of the informed consent form after oral&#xD;
             and written information about the protocol through the patient information document.&#xD;
&#xD;
          -  Volunteers that could undergo 1h15 to 1h30 immobilization (MRI exam duration in time).&#xD;
&#xD;
        PET/MRI exam inclusion criteria&#xD;
&#xD;
          -  Male volunteer aged in the range 18 to 35 years.&#xD;
&#xD;
          -  Acceptance of the research protocol: signature of the informed consent form after oral&#xD;
             and written information about the protocol through the patient information document.&#xD;
&#xD;
          -  Volunteers that could undergo 1.5 to 2.0 hours immobilization (PET/MRI exam duration&#xD;
             in time).&#xD;
&#xD;
          -  Volunteers should practice regular physical activity, defined as 50 min per day (in a&#xD;
             single session), 2 days per week of physical activity as a minimum (no maximum is&#xD;
             fixed).&#xD;
&#xD;
        Exclusion criteria MRI exam exclusion criteria&#xD;
&#xD;
          -  Pre-existing neurological or muscular lesions on the legs.&#xD;
&#xD;
          -  Co morbidities impeding on the protocol comprehension or fulfilment.&#xD;
&#xD;
          -  Illnesses that do not allow to lay down on an examination table.&#xD;
&#xD;
          -  Pacemaker holder.&#xD;
&#xD;
          -  Metal implants that would preclude MRI imaging&#xD;
&#xD;
          -  Claustrophobia: Subjects will be questioned about possible discomfort with being in an&#xD;
             enclosed space (e.g., MRI scanner). Those who report such problems will be excluded.&#xD;
&#xD;
        PET/MRI exam exclusion criteria&#xD;
&#xD;
          -  Medical radiation exposure within the last five years (normal population should not be&#xD;
             exposed to medical radiation higher or equal to 1 mSv per year).&#xD;
&#xD;
          -  Pre-existing neurological or muscular lesions on the legs.&#xD;
&#xD;
          -  Co morbidities impeding on the protocol comprehension or fulfilment.&#xD;
&#xD;
          -  Illnesses that do not allow to lay down on an examination table.&#xD;
&#xD;
          -  Pacemaker holder.&#xD;
&#xD;
          -  Metal implants that would preclude MRI imaging&#xD;
&#xD;
          -  Claustrophobia: Subjects will be questioned about possible discomfort with being in an&#xD;
             enclosed space (e.g., MRI scanner). Those who report such problems will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Osman Ratib, Pr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Medecine Nucléaire et Imagerie moléculaire- HUG</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Osman Ratib</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>PET/MRI</keyword>
  <keyword>muscular activity</keyword>
  <keyword>11C-acetate</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02969603
org study id: 2013DR2115
nct id: NCT02969603
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Assessment of musculoskeletal systems in motion
time frame: though study completion, an average of 2 years
description: an informatic visualization tool of muscles implied in leg flexion/extension combining PET and MR infomation
measure: Distribution of acetate metabolism during exercise skeletal muscle
time frame: though study completion, an average of 2 years
description: 11C-acetate uptake (SUV and SUVratio with resting muscles) in contracting muscle, measured using muscle segmentation from MRI images
measure: Measurement of the in vivo function of the muscle
time frame: though study completion, an average of 2 years
description: correlation between 11C-acetate uptake and contractile force measures (weight and duration of exercise)
arm group label: Healthy volunteers- MRI
arm group type: Other
description: MRI scan for morphological assessment of muscle structures and anatomy
arm group label: Healthy Volunteers- PET/MRI
arm group type: Other
description: The volunteers will undergo a combined [11C]acetate PET/MRI scan
intervention type: Other
intervention name: Magnetic Resonance Imaging
description: Magnetic Resonance Imaging as reference
arm group label: Healthy volunteers- MRI
intervention type: Other
intervention name: Magnetic Resonance combined with Positron Emission Tomography
description: 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
arm group label: Healthy Volunteers- PET/MRI
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Osman Ratib, Pr.
role: Principal Investigator
affiliation: University Hospital, Geneva
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Osman Ratib
investigator title: Dr.