<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/NCT03028675</url>
  </required_header>
  <id_info>
    <org_study_id>16-01434</org_study_id>
    <nct_id>NCT03028675</nct_id>
  </id_info>
  <brief_title>pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress</brief_title>
  <official_title>pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for&#xD;
      this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical&#xD;
      Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a&#xD;
      1-hour brain scan for both patients and controls. In the first 6 months of the study,&#xD;
      investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement&#xD;
      and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air&#xD;
      and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI,&#xD;
      pH-weighted imaging will be validated for its robustness and reproducibility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The contrast agent (Gd-DTPA, Gadavist) will be injected intravenously (IV) in the arm&#xD;
      (patients only). The IV will be inserted by qualified medical professional at CBI. This&#xD;
      contrast agent will be standard dose in accordance with its FDA approved labeling and dosing.&#xD;
      Controls will NOT be administered the contrast agent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">August 10, 2018</completion_date>
  <primary_completion_date type="Actual">August 10, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pH measurements</measure>
    <time_frame>20 Minutes</time_frame>
    <description>The pH will be estimated based on the calibration methods of quantification of exchange as a function of saturation time (QUEST)32 and its ratiometric analysis (QUESTRA) 33.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <description>10 age-matched control volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI Scan</intervention_name>
    <description>MRI scans will consist of a 1-hour brain scan for both patients and controls.</description>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with relapse-remitting multiple sclerosis from NYU Langone Health and age-matched&#xD;
        healthy volunteers recruiting using previous database of volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female non-MS control volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable or with cardiac, pulmonary, hematological, renal, or hepatic&#xD;
             dysfunction.&#xD;
&#xD;
          -  Current or past DSM-IV diagnosis of major depression, bipolar and psychotic disorders.&#xD;
&#xD;
          -  Contraindications for MRI, including&#xD;
&#xD;
          -  Intracranial clips&#xD;
&#xD;
          -  Metal implants&#xD;
&#xD;
          -  External metallic devices/objects/clips within 10mm of the head&#xD;
&#xD;
          -  Suspected or confirmed metal in the eyes (history of welding or similar activity)&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Cardiac pacemaker or pacing wires&#xD;
&#xD;
          -  Pregnancy - Pregnancy tests will be offered to women of childbearing age at no cost to&#xD;
             the subject&#xD;
&#xD;
          -  History of moderate to severe head injury, stroke, and seizures.&#xD;
&#xD;
          -  Alcoholism or drug dependency.&#xD;
&#xD;
          -  Renal or liver disease as this may cause concerns related to Gd-DTPA contrast agent.&#xD;
&#xD;
               -  Allergy to the contrast agent Gadolinium&#xD;
&#xD;
               -  Relapses or steroid therapy in patient at or in the month preceding the study&#xD;
&#xD;
               -  Patients only&#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>Yulin Ge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <!-- 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/NCT03028675
org study id: 16-01434
nct id: NCT03028675
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for
      this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical
      Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a
      1-hour brain scan for both patients and controls. In the first 6 months of the study,
      investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement
      and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air
      and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI,
      pH-weighted imaging will be validated for its robustness and reproducibility.
The contrast agent (Gd-DTPA, Gadavist) will be injected intravenously (IV) in the arm
      (patients only). The IV will be inserted by qualified medical professional at CBI. This
      contrast agent will be standard dose in accordance with its FDA approved labeling and dosing.
      Controls will NOT be administered the contrast agent.
observational model: Case-Control
time perspective: Prospective
measure: pH measurements
time frame: 20 Minutes
description: The pH will be estimated based on the calibration methods of quantification of exchange as a function of saturation time (QUEST)32 and its ratiometric analysis (QUESTRA) 33.
arm group label: Multiple Sclerosis
arm group label: Healthy Volunteer
description: 10 age-matched control volunteers
intervention type: Other
intervention name: MRI Scan
description: MRI scans will consist of a 1-hour brain scan for both patients and controls.
arm group label: Healthy Volunteer
arm group label: Multiple Sclerosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yulin Ge, MD
role: Principal Investigator
affiliation: New York University Medical School
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis