<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/NCT04435821</url>
  </required_header>
  <id_info>
    <org_study_id>52830</org_study_id>
    <nct_id>NCT04435821</nct_id>
  </id_info>
  <brief_title>PET/MRI in the Diagnosis of Pediatric Chronic Pain</brief_title>
  <official_title>Use of PET/MRI in the Diagnosis of Pediatric Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      [18F]FTC-146 is a sigma-1 receptor detector and is an experimental radiotracer. Several&#xD;
      studies have implicated involvement of sigma-1 receptors in generation and perpetuation of&#xD;
      chronic pain conditions, while others are investigating anti sigma-1 receptor drugs for&#xD;
      treatment of chronic pain. Using [18F]-FTC-146 and PET/MRI, we hope to learn what is the best&#xD;
      approach to identify the source of pain generation and characterize the disease in pediatric&#xD;
      patients with chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is estimated that 20% to 35% of children and adolescents worldwide are affected by chronic&#xD;
      pain. As a result of chronic pain, children may miss school, withdraw from social activities,&#xD;
      and develop internalizing behaviors. Therefore, accurately identifying the cause of a child's&#xD;
      pain is important for both proper treatment of the pain and to prevent problems secondary to&#xD;
      the chronic pain. Evidence in the literature points strongly toward an involvement of the&#xD;
      sigma-1 receptor in neurogenic inflammation, which is known to be an important&#xD;
      pathophysiological mechanism for maintenance and perpetuation of chronic neuropathic pain.&#xD;
      The investigators hope to image and identify activated pain pathways in pediatric pain&#xD;
      paitents using a radiolabeled biomarker for increased S1R expression. By localizing and&#xD;
      quantifying areas of increased S1R expression to sites of augmented nociceptive activity&#xD;
      using hybrid molecular/anatomic imaging techniques, we will objectively identify sites of&#xD;
      neurogenic inflammatory activity and pain generation. The ability to image the changes&#xD;
      associated with chronic pain generating pathologies provides us with a tool to identify and&#xD;
      measure the intensity of the pathology. Imaging S1R expression in chronic pain states in&#xD;
      pediatric patients would be both novel in its application and extremely powerful in better&#xD;
      characterizing pediatric pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 19, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>
    <intervention_model_description>Pediatric Chronic Pain Patients</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients</measure>
    <time_frame>3 hours</time_frame>
    <description>Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Pediatric Disorder</condition>
  <condition>Neuropathic Pain</condition>
  <condition>Nociceptive Pain</condition>
  <arm_group>
    <arm_group_label>Pediatric Chronic Pain Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals 11-18 years old, with chronic pain (lasting at least 2 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F]FTC-146</intervention_name>
    <description>Participants will be injected with 0.08 mCi/kg [18F]FTC-146. A whole-body PET/MRI scan will be performed after injection.</description>
    <arm_group_label>Pediatric Chronic Pain Patients</arm_group_label>
    <other_name>S1R</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  11-18 years old.&#xD;
&#xD;
          -  Chronic pain (nociceptive, neuropathic or mixed pain) lasting at least 2 months.&#xD;
&#xD;
          -  Pain level of at least 4/10 on a 0-10 Comparative Pain Scale (reported at time of&#xD;
             screening).&#xD;
&#xD;
          -  Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative&#xD;
             test result from the Covid test within 72 hours of the scan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MRI incompatible&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Non-English speaker&#xD;
&#xD;
          -  Claustrophobic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen R Nadel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Helen Ruth Nadel</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>PET/MRI</keyword>
  <keyword>Pediatric Chronic Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Nociceptive Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04435821
org study id: 52830
nct id: NCT04435821
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
[18F]FTC-146 is a sigma-1 receptor detector and is an experimental radiotracer. Several
      studies have implicated involvement of sigma-1 receptors in generation and perpetuation of
      chronic pain conditions, while others are investigating anti sigma-1 receptor drugs for
      treatment of chronic pain. Using [18F]-FTC-146 and PET/MRI, we hope to learn what is the best
      approach to identify the source of pain generation and characterize the disease in pediatric
      patients with chronic pain.
It is estimated that 20% to 35% of children and adolescents worldwide are affected by chronic
      pain. As a result of chronic pain, children may miss school, withdraw from social activities,
      and develop internalizing behaviors. Therefore, accurately identifying the cause of a child's
      pain is important for both proper treatment of the pain and to prevent problems secondary to
      the chronic pain. Evidence in the literature points strongly toward an involvement of the
      sigma-1 receptor in neurogenic inflammation, which is known to be an important
      pathophysiological mechanism for maintenance and perpetuation of chronic neuropathic pain.
      The investigators hope to image and identify activated pain pathways in pediatric pain
      paitents using a radiolabeled biomarker for increased S1R expression. By localizing and
      quantifying areas of increased S1R expression to sites of augmented nociceptive activity
      using hybrid molecular/anatomic imaging techniques, we will objectively identify sites of
      neurogenic inflammatory activity and pain generation. The ability to image the changes
      associated with chronic pain generating pathologies provides us with a tool to identify and
      measure the intensity of the pathology. Imaging S1R expression in chronic pain states in
      pediatric patients would be both novel in its application and extremely powerful in better
      characterizing pediatric pain.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pediatric Chronic Pain Patients
primary purpose: Diagnostic
masking: None (Open Label)
measure: [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients
time frame: 3 hours
description: Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.
arm group label: Pediatric Chronic Pain Patients
arm group type: Experimental
description: Individuals 11-18 years old, with chronic pain (lasting at least 2 months).
intervention type: Drug
intervention name: [18F]FTC-146
description: Participants will be injected with 0.08 mCi/kg [18F]FTC-146. A whole-body PET/MRI scan will be performed after injection.
arm group label: Pediatric Chronic Pain Patients
other name: S1R
criteria: 
gender: All
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: No
last name: Helen R Nadel, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Helen Ruth Nadel
investigator title: Clinical Professor
mesh term: Neuralgia
mesh term: Chronic Pain
mesh term: Nociceptive Pain
sharing ipd: No