<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/NCT02237872</url>
  </required_header>
  <id_info>
    <org_study_id>14-1980</org_study_id>
    <nct_id>NCT02237872</nct_id>
  </id_info>
  <brief_title>Detection of Brown Adipose Tissue by Magnetic Resonance Imaging</brief_title>
  <acronym>BAT_PET/MRI</acronym>
  <official_title>Assessment of MRI Accuracy for the Detection of Brown Adipose Tissue Using 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose -PET as a Gold Standard</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Translational and Clinical Sciences Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to assess the accuracy of conventional fat fraction proton&#xD;
      MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using&#xD;
      18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose -PET as gold standard.&#xD;
&#xD;
      In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed&#xD;
      on a combined PET/MRI scanner under mild cold condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the fight against obesity, brown adipose tissue (BAT) is considered to be the newest&#xD;
      target. The hypothesis is that this tissue is partially responsible for the imbalance between&#xD;
      energy intake and energy expenditure that keeps lean people lean and obese people obese.&#xD;
&#xD;
      The detection of this tissue in adult humans represents an unmet need. BAT is difficult to&#xD;
      detect and measurements of tissue fat fraction performed by magnetic resonance imaging have&#xD;
      been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated&#xD;
      white adipose tissue and from muscle.&#xD;
&#xD;
      To this end, the objective of this study is to assess the accuracy of magnetic resonance fat&#xD;
      fraction measurements for the detection of BAT volume in adult humans, while using PET with&#xD;
      18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose as gold standard.&#xD;
&#xD;
      For this study subjects will undergo a combined MRI/PET scan. The scans will be done during&#xD;
      stimulation of thermogenic activity by mild cold exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Average dice similarity coefficient</measure>
    <time_frame>Up to 1 year after the imaging scan</time_frame>
    <description>The average dice similarity coefficient will be measured to assess the overlap between MRI and PET maps</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adult human with a BMI &lt;28&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each subject must be fully informed and have signed consent.&#xD;
&#xD;
          -  BMI &lt; 34&#xD;
&#xD;
          -  Normal neurological and psychological development / able to give consent&#xD;
&#xD;
          -  Willingness to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects less than 18 years of age&#xD;
&#xD;
          -  Severe claustrophobia&#xD;
&#xD;
          -  Women who are pregnant, nursing an infant or planning to become pregnant in the next&#xD;
             30 days&#xD;
&#xD;
          -  People who have a condition that makes MRI unsafe for them (for example, cardiac&#xD;
             pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, iron&#xD;
             filings in your eyes or metal halo devices)&#xD;
&#xD;
          -  Have had radiation therapy or chemotherapy in the 2 months prior to PET scan&#xD;
&#xD;
          -  Subjects are taking medications that may interfere with BAT detection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosa Tamara Branca, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kristine Baluyot</last_name>
    <phone>(919) 843-5420</phone>
    <email>kristine_baluyot@med.unc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Biomedical Research Imaging Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7513</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristine Baluyot</last_name>
      <phone>919-843-5420</phone>
      <email>kristine_baluyot@med.unc.edu</email>
    </contact>
    <investigator>
      <last_name>Rosa Tamara Branca, P</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Biomedical Research Imaging Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristine Baluyot</last_name>
      <phone>919-843-5420</phone>
      <email>kristine_baluyot@med.unc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brown Adipose Tissue</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02237872
org study id: 14-1980
nct id: NCT02237872
lead sponsor: 
collaborator: 
has dmc: Yes
The primary goal of this study is to assess the accuracy of conventional fat fraction proton
      MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using
      18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose -PET as gold standard.

      In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed
      on a combined PET/MRI scanner under mild cold condition.
In the fight against obesity, brown adipose tissue (BAT) is considered to be the newest
      target. The hypothesis is that this tissue is partially responsible for the imbalance between
      energy intake and energy expenditure that keeps lean people lean and obese people obese.

      The detection of this tissue in adult humans represents an unmet need. BAT is difficult to
      detect and measurements of tissue fat fraction performed by magnetic resonance imaging have
      been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated
      white adipose tissue and from muscle.

      To this end, the objective of this study is to assess the accuracy of magnetic resonance fat
      fraction measurements for the detection of BAT volume in adult humans, while using PET with
      18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose as gold standard.

      For this study subjects will undergo a combined MRI/PET scan. The scans will be done during
      stimulation of thermogenic activity by mild cold exposure.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Average dice similarity coefficient
time frame: Up to 1 year after the imaging scan
description: The average dice similarity coefficient will be measured to assess the overlap between MRI and PET maps
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa Tamara Branca, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Kristine Baluyot
phone: (919) 843-5420
email: kristine_baluyot@med.unc.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided