<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/NCT02236143</url>
  </required_header>
  <id_info>
    <org_study_id>1212M24883</org_study_id>
    <nct_id>NCT02236143</nct_id>
  </id_info>
  <brief_title>Ultrahigh Field Body MR Imaging</brief_title>
  <official_title>Ultrahigh Field Body MR Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to develop new ways to acquire MRI data and/or new&#xD;
      ways to analyze the acquired data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The acquired data will be used to investigate the structure and function of the body. In&#xD;
      addition the developmental aspect of this study, certain information may be used to obtain&#xD;
      normal values for healthy adult structural and functional information. This information would&#xD;
      be valuable if and when the developed methods are incorporated into future clinical studies&#xD;
      involving patient populations which would be recruited under separate protocols. Our&#xD;
      hypotheses is that imaging and spectroscopy methods can be developed to a level where the&#xD;
      increased sensitivity and resolution of 7 Tesla (7T) MRI will improve the non-invasive&#xD;
      studies of the human body.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">March 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Structure and Function of MRI</measure>
    <time_frame>Baseline</time_frame>
    <description>Validate MRI measurement</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Structure and Function of MRI</condition>
  <arm_group>
    <arm_group_label>MRI</arm_group_label>
    <description>Subjects undergoing MRI</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy male or females over the age of 18, recruiting by invitation only.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female volunteer over the age of 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include those associated with the use of MR as the imaging&#xD;
             modality. The specific set of exclusion criteria for a given study will depend on the&#xD;
             specific study to be performed which will be made clear on initial contact and during&#xD;
             consent. In addition, other medical conditions deemed by the PI or associates to make&#xD;
             the patient ineligible for protocol procedures may also arise.&#xD;
&#xD;
          -  Exclusion criteria will be assessed during a safety screening interview and during&#xD;
             final consent. A questionnaire will be provided regarding general health and&#xD;
             exclusion/inclusion criteria. The investigator doing the interview will determine if&#xD;
             any of the exclusion criteria apply. Subjects will be asked:&#xD;
&#xD;
               1. To describe any previous surgeries to help subjects and study staff open a&#xD;
                  dialogue as to any possible contraindications listed in the yes/no section below.&#xD;
&#xD;
               2. If they are claustrophobic and to rate the severity.&#xD;
&#xD;
               3. If they wear hearing aids and if they can be removed for the scan.&#xD;
&#xD;
               4. If they have a transdermal delivery system, and if yes where is it located and if&#xD;
                  it can be removed for the study.&#xD;
&#xD;
               5. If they wear colored contact lenses and, if yes, can they be removed for the&#xD;
                  study.&#xD;
&#xD;
               6. To provide a list of medications, dosages and time of last dose for medicines&#xD;
                  taken regularly.&#xD;
&#xD;
               7. To identify if they have any pre-existing medical conditions including&#xD;
                  Hypertension, Hypotension, Diabetes, Cardiovascular Disease and Fever.&#xD;
&#xD;
               8. To identify if they ever had an operation.&#xD;
&#xD;
               9. To indicate if they have ever been injured by a metallic foreign body which was&#xD;
                  never removed.&#xD;
&#xD;
              10. If they wear braces and/or if they have removable bridgework, false teeth or a&#xD;
                  permanent retainer.&#xD;
&#xD;
              11. If they have any tattoos, non-removable body piercings or hair extensions.&#xD;
&#xD;
              12. If they are currently using/wearing an IUD or diaphragm.&#xD;
&#xD;
              13. If they have any reason to believe they are pregnant. (If the subjects are unsure&#xD;
                  about their pregnancy status, test kits will be available to subjects).&#xD;
&#xD;
          -  In addition, a set of yes/no questions will be asked in the screening form for the&#xD;
             patient to confirm or deny the presence of items that may be hazardous to their safety&#xD;
             and/or some interfere with the MRI examination, including:&#xD;
&#xD;
        No Cardiac pacemaker&#xD;
&#xD;
        No Implanted cardiac defibrillator&#xD;
&#xD;
        No Carotid artery vascular clamp&#xD;
&#xD;
        No Intravascular stents, filters, or coils&#xD;
&#xD;
        No Aortic clip&#xD;
&#xD;
        No Internal pacing wires&#xD;
&#xD;
        No Vascular access port and/or catheter&#xD;
&#xD;
        No Swan-Ganz catheter&#xD;
&#xD;
        No Shunt (spinal or intraventricular)&#xD;
&#xD;
        No Aneurysm clip(s)&#xD;
&#xD;
        No Neurostimulator&#xD;
&#xD;
        No Electrodes (on body, head, or brain)&#xD;
&#xD;
        No Heart valve prosthesis&#xD;
&#xD;
        No Any type of prosthesis (eye, penile, etc.)&#xD;
&#xD;
        No Artificial limb or joint replacement&#xD;
&#xD;
        No Bone growth/fusion stimulator&#xD;
&#xD;
        No Bone/joint pin, screw, nail, wire, plate&#xD;
&#xD;
        No Metal rods in bones&#xD;
&#xD;
        No Harrington rods (spine)&#xD;
&#xD;
        No Metal or wire mesh implants&#xD;
&#xD;
        No Wire sutures or surgical staples&#xD;
&#xD;
        No Insulin pump or infusion device&#xD;
&#xD;
        No Any metal fragments (i.e. metal shop)&#xD;
&#xD;
        No Any implant held in place by a magnet&#xD;
&#xD;
        No Cochlear, otologic, or ear implant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Greg Meztger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota CMRR</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>March 13, 2013</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</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/NCT02236143
org study id: 1212M24883
nct id: NCT02236143
lead sponsor: 
has dmc: No
The primary objective of this study is to develop new ways to acquire MRI data and/or new
      ways to analyze the acquired data.
The acquired data will be used to investigate the structure and function of the body. In
      addition the developmental aspect of this study, certain information may be used to obtain
      normal values for healthy adult structural and functional information. This information would
      be valuable if and when the developed methods are incorporated into future clinical studies
      involving patient populations which would be recruited under separate protocols. Our
      hypotheses is that imaging and spectroscopy methods can be developed to a level where the
      increased sensitivity and resolution of 7 Tesla (7T) MRI will improve the non-invasive
      studies of the human body.
observational model: Case-Control
time perspective: Prospective
measure: Structure and Function of MRI
time frame: Baseline
description: Validate MRI measurement
arm group label: MRI
description: Subjects undergoing MRI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Greg Meztger, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor