<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/NCT02240797</url>
  </required_header>
  <id_info>
    <org_study_id>S13-00990</org_study_id>
    <nct_id>NCT02240797</nct_id>
  </id_info>
  <brief_title>Kappa Opioid Receptor Imaging in Anorexia</brief_title>
  <official_title>Kappa Opioid Receptor Imaging in Anorexia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to use positron emission tomography (PET) imaging and magnetic&#xD;
      resonance imaging (MRI) to understand the brain function of individuals with anorexia nervosa&#xD;
      and healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 3-year study involving n=7 women with anorexia nervosa - recovered (AN-REC) from&#xD;
      restricting subtype that have achieved a body mass index (BMI) &gt; 18.5 in the past year, are&#xD;
      medication free, range in age from 18-55 years and n=7 healthy (medical and psychiatric&#xD;
      statues) age- and weight-matched controls who are invited to participate in a medical and&#xD;
      psychiatric evaluation, neuroendocrine assessments, one magnetic resonance imaging (MRI)&#xD;
      study and one positron emission tomography (PET) study kappa opioid receptor (KOR) 11-carbon&#xD;
      (11C) [11C]PKAB and PET. Subjects will be asked to provide written informed consent after&#xD;
      full explanation of all study procedures and risks and benefits related to study&#xD;
      participation. On the screening day a full medical evaluation including blood work, urine&#xD;
      analyses, toxicology, electrocardiogram (ECG) and physical exam will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Volume of distribution (VT) (i.e., KOR binding) using [11C]PKAB and PET imaging</measure>
    <time_frame>Two months</time_frame>
    <description>In this study we are using the KOR radioligand [11C]PKAB and PET to investigate group differences in cerebral KOR binding potential in 7 AN-REC and 7 healthy controls (HCs).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Anorexia Nervosa - Recovered (AN-REC)</arm_group_label>
    <description>Anorexia Nervosa - Recovered (AN-REC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control (HC)</arm_group_label>
    <description>Healthy Control (HC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Positron emission tomography (PET) imaging</intervention_name>
    <description>Positron emission tomography (PET) imaging</description>
    <arm_group_label>Anorexia Nervosa - Recovered (AN-REC)</arm_group_label>
    <arm_group_label>Healthy Control (HC)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects are female, between the age range of 18 to 55, are medically healthy and currently&#xD;
        not taking any medications to treat any medical illness, and have a history of anorexia&#xD;
        nervosa and are recovered or never had a history of anorexia nervosa.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for anorexic patients:&#xD;
&#xD;
          1. Able to understand the consent form document&#xD;
&#xD;
          2. A willingness to participate in a psychiatric evaluation, collection of behavioral&#xD;
             ratings and neuroendocrine assessments, and imaging studies including 1 PET scan and 1&#xD;
             MRI scan&#xD;
&#xD;
          3. Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)&#xD;
             Anorexia Nervosa (AN)&#xD;
&#xD;
          4. Subjects will be between 18 and 55 years of age&#xD;
&#xD;
          5. Currently weight restored with a body mass index (BMI) &gt; 18.5 for longer than 3 months&#xD;
&#xD;
        Inclusion criteria for healthy controls:&#xD;
&#xD;
          1. Able to understand the consent form document&#xD;
&#xD;
          2. A willingness to participate in a psychiatric evaluation, collection of behavioral&#xD;
             ratings and neuroendocrine assessments, and imaging studies including 1 PET scan and 1&#xD;
             MRI scan&#xD;
&#xD;
          3. Subjects will be between 18 and 55 years of age&#xD;
&#xD;
          4. Regular menstruation and no personal or first-degree family history of any Axis I&#xD;
             diagnosis based on DSM-IV criteria&#xD;
&#xD;
        Exclusion criteria for anorexic patients:&#xD;
&#xD;
          1. Any major neurological illness or injury&#xD;
&#xD;
          2. Presence of any legal or illegal psychoactive substances determined with urine&#xD;
             toxicology, and breathalyzer test for alcohol&#xD;
&#xD;
          3. Any significant unstable medical condition such as asthma or heart disease which may&#xD;
             limit the interpretation of the imaging results, for example due to changes in tracer&#xD;
             delivery in hypertensive patients&#xD;
&#xD;
          4. Intelligence quotient (IQ)&lt;70 based on past intelligence&#xD;
&#xD;
          5. Any metal in body that would pose a risk with MRI&#xD;
&#xD;
          6. Claustrophobia that would interfere with MRI or PET imaging&#xD;
&#xD;
          7. Currently pregnant or nursing&#xD;
&#xD;
        Exclusion criteria for healthy controls:&#xD;
&#xD;
          1. Any major neurological illness or injury&#xD;
&#xD;
          2. Presence of any legal or illegal psychoactive substances determined with urine&#xD;
             toxicology, and breathalyzer test for alcohol&#xD;
&#xD;
          3. Any significant unstable medical condition such as asthma or heart disease which may&#xD;
             limit the interpretation of the imaging results, for example due to changes in tracer&#xD;
             delivery in hypertensive patients&#xD;
&#xD;
          4. IQ&lt;70 based on past intelligence&#xD;
&#xD;
          5. Any metal in body that would pose a risk with MRI&#xD;
&#xD;
          6. Claustrophobia that would interfere with MRI or PET imaging&#xD;
&#xD;
          7. Currently pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Marmar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>August 15, 2016</last_update_submitted>
  <last_update_submitted_qc>August 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anorexia Nervosa</keyword>
  <keyword>Neuroimaging</keyword>
  <keyword>Positron emission tomography (PET)</keyword>
  <keyword>[11C]PKAB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Anorexia Nervosa</mesh_term>
  </condition_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/NCT02240797
org study id: S13-00990
nct id: NCT02240797
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to use positron emission tomography (PET) imaging and magnetic
      resonance imaging (MRI) to understand the brain function of individuals with anorexia nervosa
      and healthy controls.
This is a 3-year study involving n=7 women with anorexia nervosa - recovered (AN-REC) from
      restricting subtype that have achieved a body mass index (BMI) > 18.5 in the past year, are
      medication free, range in age from 18-55 years and n=7 healthy (medical and psychiatric
      statues) age- and weight-matched controls who are invited to participate in a medical and
      psychiatric evaluation, neuroendocrine assessments, one magnetic resonance imaging (MRI)
      study and one positron emission tomography (PET) study kappa opioid receptor (KOR) 11-carbon
      (11C) [11C]PKAB and PET. Subjects will be asked to provide written informed consent after
      full explanation of all study procedures and risks and benefits related to study
      participation. On the screening day a full medical evaluation including blood work, urine
      analyses, toxicology, electrocardiogram (ECG) and physical exam will be performed.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Volume of distribution (VT) (i.e., KOR binding) using [11C]PKAB and PET imaging
time frame: Two months
description: In this study we are using the KOR radioligand [11C]PKAB and PET to investigate group differences in cerebral KOR binding potential in 7 AN-REC and 7 healthy controls (HCs).
arm group label: Anorexia Nervosa - Recovered (AN-REC)
description: Anorexia Nervosa - Recovered (AN-REC)
arm group label: Healthy Control (HC)
description: Healthy Control (HC)
intervention type: Other
intervention name: Positron emission tomography (PET) imaging
description: Positron emission tomography (PET) imaging
arm group label: Anorexia Nervosa - Recovered (AN-REC)
arm group label: Healthy Control (HC)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Marmar, MD
role: Principal Investigator
affiliation: NYU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa