<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/NCT03759522</url>
  </required_header>
  <id_info>
    <org_study_id>R18-118</org_study_id>
    <nct_id>NCT03759522</nct_id>
  </id_info>
  <brief_title>Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.</brief_title>
  <acronym>DPA-714</acronym>
  <official_title>Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to measure the concentration and the regional brain&#xD;
      distribution of activated brain microglia/macrophages using the PET radiopharmaceutical&#xD;
      [F-18]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with&#xD;
      neuroinflammation. The PET tracer [F-18]DPA-714 binds to the 18 kDa translocator protein&#xD;
      (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated&#xD;
      microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary&#xD;
      objective of this study is to determine if pain and fatigue patients have higher levels of&#xD;
      neuroinflammation than HC individuals as measured with [F-18]DPA-714-PET/MRI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 3, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.</measure>
    <time_frame>3 years</time_frame>
    <description>Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and/or fatigue.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Chronic Fatigue Syndrome</condition>
  <condition>Multiple Sclerosis</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fibromyalgia Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Fatigue Syndrome Subjets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Sclerosis Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DPA-714 PET/MRI</intervention_name>
    <description>DPA-714 PET/MRI</description>
    <arm_group_label>Chronic Fatigue Syndrome Subjets</arm_group_label>
    <arm_group_label>Fibromyalgia Subjects</arm_group_label>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>Multiple Sclerosis Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 to 65 years of age&#xD;
&#xD;
          2. Healthy volunteer OR Clinical diagnosis of Multiple Sclerosis (MS) OR Meets 2016&#xD;
             American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR&#xD;
             Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to MRI&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. Lactation&#xD;
&#xD;
          4. Individuals who are unable to participate in the imaging portion due to severity of&#xD;
             their medical condition&#xD;
&#xD;
          5. Chronic infectious disease (e.g. HIV, HCV)&#xD;
&#xD;
          6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1&#xD;
             month of study participation&#xD;
&#xD;
          7. Diagnosis of cancer, including leukemia&#xD;
&#xD;
          8. Blood or blood clotting disorder&#xD;
&#xD;
          9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary&#xD;
&#xD;
         10. Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior&#xD;
             to the administration of [18F]DPA-714&#xD;
&#xD;
         11. Currently enrolled in a clinical trial utilizing experimental therapies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jared Younger, PhD</last_name>
    <phone>205-975-5907</phone>
    <email>youngerlab@uab.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alabama at Birmingham Medical Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan McConathy, MD</last_name>
      <phone>205-996-7115</phone>
      <email>jmcconathy@uabmc.edu</email>
    </contact>
    <investigator>
      <last_name>Jonathan McConathy, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bag Asim, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bhambhvani Pradeep, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Choudhary Gagandeep, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Geldmacher David, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lapi Suzanne, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeffers Charlotte Denise, RPh</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Natelson Marissa, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberson Erik, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Jonathan E McConathy</investigator_full_name>
    <investigator_title>M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Neuroinflammatory Diseases</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/NCT03759522
org study id: R18-118
nct id: NCT03759522
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to measure the concentration and the regional brain
      distribution of activated brain microglia/macrophages using the PET radiopharmaceutical
      [F-18]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with
      neuroinflammation. The PET tracer [F-18]DPA-714 binds to the 18 kDa translocator protein
      (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated
      microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary
      objective of this study is to determine if pain and fatigue patients have higher levels of
      neuroinflammation than HC individuals as measured with [F-18]DPA-714-PET/MRI.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI.
time frame: 3 years
description: Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and/or fatigue.
arm group label: Healthy Controls
arm group type: Experimental
arm group label: Fibromyalgia Subjects
arm group type: Experimental
arm group label: Chronic Fatigue Syndrome Subjets
arm group type: Experimental
arm group label: Multiple Sclerosis Subjects
arm group type: Experimental
intervention type: Drug
intervention name: DPA-714 PET/MRI
description: DPA-714 PET/MRI
arm group label: Chronic Fatigue Syndrome Subjets
arm group label: Fibromyalgia Subjects
arm group label: Healthy Controls
arm group label: Multiple Sclerosis Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jared Younger, PhD
phone: 205-975-5907
email: youngerlab@uab.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Jonathan E McConathy
investigator title: M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics
mesh term: Fibromyalgia
mesh term: Fatigue Syndrome, Chronic
mesh term: Multiple Sclerosis
mesh term: Neuroinflammatory Diseases