<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/NCT02220426</url>
  </required_header>
  <id_info>
    <org_study_id>14-1211</org_study_id>
    <nct_id>NCT02220426</nct_id>
  </id_info>
  <brief_title>Hyperpolarized Xenon-129 Magnetic Resonance Imaging and Spectroscopy of Brown Fat: Healthy Adult Volunteer Pilot Study</brief_title>
  <official_title>Phase 1 Study: Detection of Brown Adipose Tissue in Normal Volunteers Using a 3 Tesla (3T) Magnetic Resonance Imaging System and Hyperpolarized (HP) Xenon Gas</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 evaluate the feasibility of detecting Brown Adipose&#xD;
      Tissue (BAT) in healthy subjects by using hyperpolarized xenon gas MRI.&#xD;
&#xD;
      In this pilot study, MRI of BAT of healthy adult volunteers will be performed at 3 Tesla to&#xD;
      assess image quality using a prototype surface coil and pulse sequence following inhalation&#xD;
      of hyperpolarized 129Xe (xenon) gas at thermoneutrality and under mild cold condition.&#xD;
&#xD;
      The investigators are testing the abilities of xenon MRI to see brown adipose tissue and&#xD;
      detect its thermogenic activity.&#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;
      As the detection of this tissue in adult humans is difficult, this study aim to evaluate the&#xD;
      use of hyperpolarized xenon gas MRI for the detection of this tissue.&#xD;
&#xD;
      Hyperpolarized xenon gas MRI is currently used for lung ventilation studies. For this study&#xD;
      subjects will undergo an MRI scan for which they will also inhaled hyperpolarized xenon.&#xD;
      Scans will be done before and during stimulation of thermogenic activity by cold exposure,&#xD;
      while MR images and spectra will be acquired from the supraclavicular area. We expect that&#xD;
      the inhaled gas will diffuse into blood and eventually reach BAT in a manner proportional to&#xD;
      the metabolic activity of this tissue.&#xD;
&#xD;
      Objectives of this studies are:&#xD;
&#xD;
        -  To detect BAT volume using hyperpolarized xenon MRI&#xD;
&#xD;
        -  To detect BAT thermogenic activity by hyperpolarized xenon Nuclear Magnetic Resonance&#xD;
           (NMR) spectroscopy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brow adipose tissue volume</measure>
    <time_frame>Day 1</time_frame>
    <description>Brown adipose tissue volume will be calculated as the sum of pixels whose intensity rose by more than 5% during cold stimulation multiplied by the pixel volume.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in BAT temperature</measure>
    <time_frame>Day 1</time_frame>
    <description>Change in BAT temperature will be estimated from NMR xenon spectra acquired at thermo-neutrality and under cold exposure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Xenon inhalation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Inhalation of 5 doses of 750ml of hyperpolarized 129Xe gas</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xenon</intervention_name>
    <description>Inhalation of hyperpolarized xenon gas</description>
    <arm_group_label>Xenon inhalation</arm_group_label>
    <other_name>Hyperpolarized xenon gas</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Willing to participate in this study&#xD;
&#xD;
          -  Male or female ≥ 18 years of age at the time of the interview.&#xD;
&#xD;
          -  Subject has no diagnosed pulmonary condition&#xD;
&#xD;
          -  Subject has not smoked in the previous 5 years&#xD;
&#xD;
          -  Smoking history, if any, is less than or equal to 5 pack-years&#xD;
&#xD;
          -  Written informed consent (and assent when applicable) obtained from subject or&#xD;
             subject's&#xD;
&#xD;
          -  legal representative and ability for subject to comply with the requirements of the&#xD;
             study&#xD;
&#xD;
          -  Healthy subject that may or may not have undergone an fluorodeoxyglucose -PET scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to MRI (presence of any non-removable metal implant, stents,&#xD;
             pacemaker, clips, staples, or piercings, etc. )&#xD;
&#xD;
          -  Subject does not fit in the magnet&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Severe claustrophobia&#xD;
&#xD;
          -  Subject is less than 18 years old&#xD;
&#xD;
          -  MRI is contraindicated based on responses to MRI screening questionnaire&#xD;
&#xD;
          -  Subject is pregnant or lactating&#xD;
&#xD;
          -  Respiratory illness of a bacterial or viral etiology within 15 days of MRI&#xD;
&#xD;
          -  Subject has received an investigational medicinal product (not including 129Xe) within&#xD;
             30 days of MRI&#xD;
&#xD;
          -  Subject has any form of known cardiovascular disease&#xD;
&#xD;
          -  Subject cannot hold their breath for 15 seconds&#xD;
&#xD;
          -  Subject deemed unlikely to be able to comply with instructions during imaging&#xD;
&#xD;
          -  Subject is taking beta blockers&#xD;
&#xD;
          -  Subject underwent an fluorodeoxyglucose-PET examination less than one week before the&#xD;
             HP xenon MRI scan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</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, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Weili Lin</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 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>
  <keyword>Hyperpolarized xenon gas MRI</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Xenon</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02220426
org study id: 14-1211
nct id: NCT02220426
lead sponsor: 
collaborator: 
has dmc: Yes
The primary goal of this study is to evaluate the feasibility of detecting Brown Adipose
      Tissue (BAT) in healthy subjects by using hyperpolarized xenon gas MRI.

      In this pilot study, MRI of BAT of healthy adult volunteers will be performed at 3 Tesla to
      assess image quality using a prototype surface coil and pulse sequence following inhalation
      of hyperpolarized 129Xe (xenon) gas at thermoneutrality and under mild cold condition.

      The investigators are testing the abilities of xenon MRI to see brown adipose tissue and
      detect its thermogenic activity.
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.

      As the detection of this tissue in adult humans is difficult, this study aim to evaluate the
      use of hyperpolarized xenon gas MRI for the detection of this tissue.

      Hyperpolarized xenon gas MRI is currently used for lung ventilation studies. For this study
      subjects will undergo an MRI scan for which they will also inhaled hyperpolarized xenon.
      Scans will be done before and during stimulation of thermogenic activity by cold exposure,
      while MR images and spectra will be acquired from the supraclavicular area. We expect that
      the inhaled gas will diffuse into blood and eventually reach BAT in a manner proportional to
      the metabolic activity of this tissue.

      Objectives of this studies are:

        -  To detect BAT volume using hyperpolarized xenon MRI

        -  To detect BAT thermogenic activity by hyperpolarized xenon Nuclear Magnetic Resonance
           (NMR) spectroscopy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Brow adipose tissue volume
time frame: Day 1
description: Brown adipose tissue volume will be calculated as the sum of pixels whose intensity rose by more than 5% during cold stimulation multiplied by the pixel volume.
measure: Change in BAT temperature
time frame: Day 1
description: Change in BAT temperature will be estimated from NMR xenon spectra acquired at thermo-neutrality and under cold exposure
arm group label: Xenon inhalation
arm group type: Other
description: Inhalation of 5 doses of 750ml of hyperpolarized 129Xe gas
intervention type: Drug
intervention name: Xenon
description: Inhalation of hyperpolarized xenon gas
arm group label: Xenon inhalation
other name: Hyperpolarized xenon gas
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
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: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Xenon