<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/NCT03787446</url>
  </required_header>
  <id_info>
    <org_study_id>H18-02393</org_study_id>
    <nct_id>NCT03787446</nct_id>
  </id_info>
  <brief_title>PET Study in Multiple Sclerosis</brief_title>
  <official_title>Positron Emission Tomography (PET) Imaging Study in Relapsing-Remitting and Primary-Progressive Multiple Sclerosis (MS): Correlations With Advanced MRI in MS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      While both conventional and advanced MRI techniques offer important insights into MS&#xD;
      pathophysiology, important aspects of this inflammatory disorder are undetectable with&#xD;
      existing MRI technology. In Multiple Sclerosis (MS), there is growing interest in PET as an&#xD;
      imaging modality that can increase the investigator's understanding of the disease processes&#xD;
      and may add to an understanding of MS phenotype, particularly when combined with advanced MRI&#xD;
      techniques such as myelin water imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an exploratory study. PBR28 PET scan is new, promising and exploratory endpoints in&#xD;
      MS clinical trials, making sample size estimation difficult.&#xD;
&#xD;
      A separate pre-screening consent form will be issued for the TSPO rs6971 polymorphism and&#xD;
      eGFR blood samples, a separate pre-screening step. Eligible participants, according to their&#xD;
      TSPO rs6971 polymorphism will be presented a separate study consent form to continue into the&#xD;
      clinical trial.&#xD;
&#xD;
      Study Assessments include 1 PET scan, 1 MRI scan, OCT, EDSS exam, physical exam, cognitive&#xD;
      questionnaires, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Whole Brain PBR28 binding</measure>
    <time_frame>January 2020</time_frame>
    <description>To show an increase in 11C-PBR28 binding in all sub-types of MS compared to healthy controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Myelin Water Imaging by MRI</measure>
    <time_frame>January 2020</time_frame>
    <description>To quantitatively measure the brain levels of water located within myelin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical Coherence Tomography</measure>
    <time_frame>January 2020</time_frame>
    <description>To correlate brain levels of inflammation measured by 11C-PBR28 with Retinal Nerve Fiber Layer (RNFL) thickness on Optical Coherence Tomography (OCT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MS Spectroscopy</measure>
    <time_frame>January 2020</time_frame>
    <description>To correlate brain levels of inflammation and myelin measured by PET with cognitive dysfunction in MS patients.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">9</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Multiple Sclerosis (MS) patients</arm_group_label>
    <description>3 Primary Progressive MS patients on no disease modifying therapy and 3 Relapsing-Remitting MS patients on no disease modifying therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls (HC)</arm_group_label>
    <description>3 Healthy volunteers aged between 18-60 years of age</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        3 untreated RRMS, 3 untreated PPMS and 3 healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects diagnosed with Multiple Sclerosis according to the 2010 McDonald criteria or&#xD;
             otherwise in the opinion of the investigator (including relapsing-remitting and&#xD;
             primary-progressive).&#xD;
&#xD;
          -  Aged 18 to 60 years.&#xD;
&#xD;
          -  Mixed affinity binder according to rs6971 TSPO polymorphism1.&#xD;
&#xD;
          -  Creatinine clearance over 60 mL/min*). * Blood result valid up to 3 months prior to&#xD;
             the MRI scan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low and high affinity binders according to rs6971 TSPO polymorphism&#xD;
&#xD;
          -  Subject pregnant or breastfeeding.&#xD;
&#xD;
          -  Subjects with a Body Mass Index (BMI) &gt;35kg/m³.&#xD;
&#xD;
          -  Hospitalization within 1 month of screening visit.&#xD;
&#xD;
          -  Medical history or current heart failure&#xD;
&#xD;
          -  Medical history or current pulmonary failure&#xD;
&#xD;
          -  Current or Historical Drug or alcohol abuse in the opinion of the investigator.&#xD;
&#xD;
          -  Regular use of anti-inflammatory agents (more than once a week use of aspirin, NSAIDS,&#xD;
             Steroids, immunomodulating drugs), unless patient is able to washout from&#xD;
             anti-inflammatory drugs 2 weeks prior to PBR PET scan.&#xD;
&#xD;
          -  Neurological disorder other than MS, including Brain Trauma, stroke, Parkinson&#xD;
             disease, Alzheimer disease, encephalitis.&#xD;
&#xD;
          -  Subjects with a history of radiation treatment or other high amounts of radiation&#xD;
             exposure in the opinion of the investigator.&#xD;
&#xD;
          -  Subjects with a history of metastatic cancer including solid tumors and hematological&#xD;
             malignancies, except basal cell, in situ squamous cell carcinoma of the skin, and in&#xD;
             situ carcinoma of the cervix or the uterus that have been excised with clear margins.&#xD;
&#xD;
          -  Inability to tolerate lying supine for the duration of the MRI and PET scan.&#xD;
&#xD;
          -  Claustrophobia.&#xD;
&#xD;
          -  Current use of MS drugs as described by the list of prohibited medications.&#xD;
&#xD;
        Exclusion specific to MRI (All MRI specific criteria is subject to conditions posed by the&#xD;
        MRI technologist or radiologist):&#xD;
&#xD;
          -  Known or suspected piece of metal in eye(s)&#xD;
&#xD;
          -  Irremovable piercing or recent tattoos in the last 6 weeks&#xD;
&#xD;
          -  Cardiac pacemakers, wires or defibrillator&#xD;
&#xD;
          -  Artificial heart valve&#xD;
&#xD;
          -  Brain aneurysm clip&#xD;
&#xD;
          -  Electrical stimulator for nerves or bones&#xD;
&#xD;
          -  Deep brain stimulator&#xD;
&#xD;
          -  Implanted drug infusion pump&#xD;
&#xD;
          -  Coil, catheter, or filter in any blood vessel&#xD;
&#xD;
          -  Orthopedic hardware (artificial joint, plate, screws) inserted within the last 6 weeks&#xD;
&#xD;
          -  Surgery within the last 6 weeks&#xD;
&#xD;
          -  Harrington rod for scoliosis&#xD;
&#xD;
          -  Other metallic prosthesis&#xD;
&#xD;
          -  Any metal fragments, Shrapnel, bullets, or metal prosthesis&#xD;
&#xD;
          -  Irremovable dentures, braces or retainer(s)&#xD;
&#xD;
          -  IUDs containing metal&#xD;
&#xD;
          -  Previous surgery of the brain, eyes, ears, breast, chest, heart, or spine in the&#xD;
             opinion of the investigator and MRI technician(s)&#xD;
&#xD;
        Exclusion specific to OCT:&#xD;
&#xD;
          -  Medical history of Macular degeneration&#xD;
&#xD;
          -  Degenerative and/or symptomatic Retinopathy&#xD;
&#xD;
          -  Medical history of Glaucoma&#xD;
&#xD;
          -  Medical history of Amblyopia with vision loss&#xD;
&#xD;
          -  Medical history of Diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert L Carruthers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MS Clinical Trials Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Janice Jong</last_name>
    <phone>604-827-1892</phone>
    <email>janice.jong@ubc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erin Gallinger</last_name>
    <phone>604-827-1921</phone>
    <email>erin.gallinger@ubc.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UBC MS &amp; NMO Clinical Trials Group</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janice Jong</last_name>
      <phone>604-827-1892</phone>
      <email>janice.jong@ubc.ca</email>
    </contact>
    <investigator>
      <last_name>Robert L Carruthers, MD, FRCPS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Robert Carruthers</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT03787446
org study id: H18-02393
nct id: NCT03787446
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
While both conventional and advanced MRI techniques offer important insights into MS
      pathophysiology, important aspects of this inflammatory disorder are undetectable with
      existing MRI technology. In Multiple Sclerosis (MS), there is growing interest in PET as an
      imaging modality that can increase the investigator's understanding of the disease processes
      and may add to an understanding of MS phenotype, particularly when combined with advanced MRI
      techniques such as myelin water imaging.
This is an exploratory study. PBR28 PET scan is new, promising and exploratory endpoints in
      MS clinical trials, making sample size estimation difficult.

      A separate pre-screening consent form will be issued for the TSPO rs6971 polymorphism and
      eGFR blood samples, a separate pre-screening step. Eligible participants, according to their
      TSPO rs6971 polymorphism will be presented a separate study consent form to continue into the
      clinical trial.

      Study Assessments include 1 PET scan, 1 MRI scan, OCT, EDSS exam, physical exam, cognitive
      questionnaires, etc.
observational model: Cohort
time perspective: Cross-Sectional
measure: Whole Brain PBR28 binding
time frame: January 2020
description: To show an increase in 11C-PBR28 binding in all sub-types of MS compared to healthy controls.
measure: Myelin Water Imaging by MRI
time frame: January 2020
description: To quantitatively measure the brain levels of water located within myelin
measure: Optical Coherence Tomography
time frame: January 2020
description: To correlate brain levels of inflammation measured by 11C-PBR28 with Retinal Nerve Fiber Layer (RNFL) thickness on Optical Coherence Tomography (OCT).
measure: MS Spectroscopy
time frame: January 2020
description: To correlate brain levels of inflammation and myelin measured by PET with cognitive dysfunction in MS patients.
arm group label: Multiple Sclerosis (MS) patients
description: 3 Primary Progressive MS patients on no disease modifying therapy and 3 Relapsing-Remitting MS patients on no disease modifying therapy
arm group label: Healthy Controls (HC)
description: 3 Healthy volunteers aged between 18-60 years of age
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert L Carruthers, MD
role: Principal Investigator
affiliation: MS Clinical Trials Group
last name: Janice Jong
phone: 604-827-1892
email: janice.jong@ubc.ca
last name: Erin Gallinger
phone: 604-827-1921
email: erin.gallinger@ubc.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Robert Carruthers
investigator title: Principal Investigator
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No