<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/NCT02236897</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00073452</org_study_id>
    <nct_id>NCT02236897</nct_id>
  </id_info>
  <brief_title>PET Imaging in ALS Patients</brief_title>
  <official_title>Metabotropic Glutamate Receptor 5 (mGluR5) Imaging in Amyotrophic Lateral Sclerosis (ALS) Patients and Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ALS Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and&#xD;
      monitoring progression of ALS, based on a well established basic science pathway, published&#xD;
      human autopsy data, preliminary data in ALS mutant mice, and our recently published data&#xD;
      using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy&#xD;
      human volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glutamate Receptor Distribution</measure>
    <time_frame>1 year</time_frame>
    <description>The two primary outcome variables (VT and BPND) are quantitative estimates of mGluR5 distribution in the defined central nervous system regions. We will employ plasma reference graphical analysis (PRGA) which yielded the most accurate estimates of BPND and VT in a test-retest scheme. We will perform various analyses to determine if BPND or VT measurements in the volumes of interest differ between the ALS and control subject groups.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Amyotrophic Lateral Sclerosis (ALS)</condition>
  <arm_group>
    <arm_group_label>PET Scanning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Imaging of mGluR5 using PET scanning</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PET Scanning</intervention_name>
    <arm_group_label>PET Scanning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ALS patients, ranging in age from 18-80.&#xD;
&#xD;
          -  Must meet El Escorial Criteria for Probable or Definite ALS.&#xD;
&#xD;
          -  Disease duration &gt;1 year, but &lt;3 years.&#xD;
&#xD;
          -  Weakness in at least two extremities.&#xD;
&#xD;
          -  Forced vital capacity less than 80% and greater than 50%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented orthopnea or otherwise unable to lie flat in a PET scanner for 90 minutes.&#xD;
&#xD;
          -  Presence of pacemakers, aneurysm clips, shrapnel, or other implanted metallic devices&#xD;
             that would preclude an MRI scan.&#xD;
&#xD;
          -  Absence of sufficient collateral arterial circulation for radial arterial line&#xD;
             placement in both wrists.&#xD;
&#xD;
          -  Significant abnormalities of hepatic or renal function, or illicit substance use.&#xD;
&#xD;
          -  Positive drug screen. (Subjects currently taking prescribed narcotic medication who&#xD;
             have a positive drug screen for this medication will not be excluded. Medication&#xD;
             history will be obtained during screening).&#xD;
&#xD;
          -  Weighs &gt; 350 lbs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyle Ostrow, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>March 6, 2017</last_update_submitted>
  <last_update_submitted_qc>March 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Lyle W. Ostrow, MD, PhD</investigator_full_name>
    <investigator_title>Assistant Professor of Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>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/NCT02236897
org study id: NA_00073452
nct id: NCT02236897
lead sponsor: 
collaborator: 
has dmc: No
This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and
      monitoring progression of ALS, based on a well established basic science pathway, published
      human autopsy data, preliminary data in ALS mutant mice, and our recently published data
      using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy
      human volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Glutamate Receptor Distribution
time frame: 1 year
description: The two primary outcome variables (VT and BPND) are quantitative estimates of mGluR5 distribution in the defined central nervous system regions. We will employ plasma reference graphical analysis (PRGA) which yielded the most accurate estimates of BPND and VT in a test-retest scheme. We will perform various analyses to determine if BPND or VT measurements in the volumes of interest differ between the ALS and control subject groups.
arm group label: PET Scanning
arm group type: Experimental
description: Imaging of mGluR5 using PET scanning
intervention type: Other
intervention name: PET Scanning
arm group label: PET Scanning
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lyle Ostrow, MD, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Lyle W. Ostrow, MD, PhD
investigator title: Assistant Professor of Neurology
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Sclerosis