<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/NCT03807973</url>
  </required_header>
  <id_info>
    <org_study_id>R18-179</org_study_id>
    <nct_id>NCT03807973</nct_id>
  </id_info>
  <brief_title>Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.</brief_title>
  <official_title>Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.</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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI)&#xD;
      and an investigational radioactive drug called [Zr-89]oxine to track the location of white&#xD;
      blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled&#xD;
      white blood cells and determine if they enter the central nervous system in conditions&#xD;
      associated with brain inflammation (also called neuroinflammation). By better understanding&#xD;
      the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple&#xD;
      sclerosis, the investigator hopes to be able to better diagnose and treat patients in the&#xD;
      future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2021</start_date>
  <completion_date type="Anticipated">October 5, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 5, 2024</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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regional brain distribution of radiolabeled white blood cells</measure>
    <time_frame>3 years</time_frame>
    <description>Descriptive statistics (means and standard deviations) of standardized uptake values (SUVs) will be presented for the patient groups and healthy controls in the following regions: whole brain, gray matter, white matter, atlas-based regions of interest, and lesions (MS patients only). Normality of the SUV distribution will be tested using Shapiro-Wilk tests, and the data will be transformed to normal distribution if necessary.</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>Fibromyalgia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Fatigue Syndrome</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[Zr-89]Oxine-labeled leukocytes PET/MRI</intervention_name>
    <description>All study participants will undergo an investigational imaging study using autologous [Zr-89]-labeled leukocytes and brain PET/MRI. Participants will undergo a venous blood draw, and the leukocytes in the blood sample will be isolated for labeling using [Zr-89]oxine. The labeled leukocytes (7.4- 18.5 megabecquerel (MBq), 200-500 uCi) will be re-injected into the participant followed by brain PET/MRI at 24-48 hours after injection. Participants will be asked to have a second brain imaging study 3-6 days after this injection, but this second imaging study is optional.</description>
    <arm_group_label>Chronic Fatigue Syndrome</arm_group_label>
    <arm_group_label>Fibromyalgia</arm_group_label>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.18 to 65 years of age 2.Healthy volunteer OR&#xD;
&#xD;
          -  Clinical diagnosis of Multiple Sclerosis (MS) OR&#xD;
&#xD;
          -  Meets 2016 American College of Rheumatology (ACR) case definition criteria for&#xD;
             fibromyalgia OR&#xD;
&#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 pregnancy test day of procedure or a serum pregnancy test within 48&#xD;
             hours prior to the administration of Zirconium-89 Oxinate-4-labeled leukocytes&#xD;
&#xD;
         11. Currently enrolled in a clinical trial utilizing experimental therapies&#xD;
&#xD;
         12. Contraindication to gadolinium based contrast agents&#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_official>
    <last_name>Jonathan McConathy, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jonathan McConathy, MD, PhD</last_name>
    <phone>205-996-7115</phone>
    <email>jmcconathy@uabmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Evan Hudson, BS</last_name>
    <phone>205-934-6499</phone>
    <email>evanhudson@uabmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UAB</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evan Hudson, BS</last_name>
      <phone>205-934-6499</phone>
      <email>evanhudson@uabmc.edu</email>
    </contact>
    <investigator>
      <last_name>Jonathan McConathy, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>December 16, 2022</last_update_submitted>
  <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 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>MD, PhD, 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>
  </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/NCT03807973
org study id: R18-179
nct id: NCT03807973
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI)
      and an investigational radioactive drug called [Zr-89]oxine to track the location of white
      blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled
      white blood cells and determine if they enter the central nervous system in conditions
      associated with brain inflammation (also called neuroinflammation). By better understanding
      the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple
      sclerosis, the investigator hopes to be able to better diagnose and treat patients in the
      future.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Regional brain distribution of radiolabeled white blood cells
time frame: 3 years
description: Descriptive statistics (means and standard deviations) of standardized uptake values (SUVs) will be presented for the patient groups and healthy controls in the following regions: whole brain, gray matter, white matter, atlas-based regions of interest, and lesions (MS patients only). Normality of the SUV distribution will be tested using Shapiro-Wilk tests, and the data will be transformed to normal distribution if necessary.
arm group label: Fibromyalgia
arm group type: Experimental
arm group label: Chronic Fatigue Syndrome
arm group type: Experimental
arm group label: Multiple Sclerosis
arm group type: Experimental
arm group label: Healthy Controls
arm group type: Experimental
intervention type: Drug
intervention name: [Zr-89]Oxine-labeled leukocytes PET/MRI
description: All study participants will undergo an investigational imaging study using autologous [Zr-89]-labeled leukocytes and brain PET/MRI. Participants will undergo a venous blood draw, and the leukocytes in the blood sample will be isolated for labeling using [Zr-89]oxine. The labeled leukocytes (7.4- 18.5 megabecquerel (MBq), 200-500 uCi) will be re-injected into the participant followed by brain PET/MRI at 24-48 hours after injection. Participants will be asked to have a second brain imaging study 3-6 days after this injection, but this second imaging study is optional.
arm group label: Chronic Fatigue Syndrome
arm group label: Fibromyalgia
arm group label: Healthy Controls
arm group label: Multiple Sclerosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan McConathy, MD,PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Jonathan McConathy, MD, PhD
phone: 205-996-7115
email: jmcconathy@uabmc.edu
last name: Evan Hudson, BS
phone: 205-934-6499
email: evanhudson@uabmc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Jonathan E McConathy
investigator title: MD, PhD, Director for the Division Molecular Imaging and Therapeutics
mesh term: Fibromyalgia
mesh term: Fatigue Syndrome, Chronic
mesh term: Multiple Sclerosis