<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/NCT03266848</url>
  </required_header>
  <id_info>
    <org_study_id>R41DA043974</org_study_id>
    <secondary_id>R41DA043974</secondary_id>
    <nct_id>NCT03266848</nct_id>
  </id_info>
  <brief_title>Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI</brief_title>
  <official_title>Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theranano LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Theranano LLC</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the&#xD;
      method with first-in-human studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol&#xD;
      as a contrast agent, and validate the method with first-in-human studies. Subjects who are&#xD;
      already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion.&#xD;
      The ferumoxytol infusion itself is not a part of the study. The project will provide brain&#xD;
      angiograms and establish a human cerebrovascular atlas that will enable future quantitative&#xD;
      diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that&#xD;
      characterize disease, a tool which doesn't currently exist, and which could lead to many&#xD;
      exciting discoveries and clinical applications in neurology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Actual">July 22, 2020</completion_date>
  <primary_completion_date type="Actual">July 22, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebrovascular Angiography</measure>
    <time_frame>0-4 hours after ferumoxytol infusion</time_frame>
    <description>Obtain angiograms of the cerebral vasculature from the MRI intensity data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative cerebral blood volume atlas</measure>
    <time_frame>0-4 hours after ferumoxytol infusion</time_frame>
    <description>Create cerebral blood volume atlas from the quantitative MRI intensity data</description>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Cerebrovascular Disorders</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantitative Magnetic Resonance Imaging</intervention_name>
    <description>Radiological diagnosis</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Subject blood sample before each scan&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with iron deficiency anemia already scheduled to receive ferumoxytol infusion for&#xD;
        iron replacement therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18 to 80;&#xD;
&#xD;
          -  Able to understand written consent document and HIPAA authorization prior to&#xD;
             initiation of study related procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to ferumoxytol or any intravenous iron preparation;&#xD;
&#xD;
          -  Iron saturation above the upper limit of normal;&#xD;
&#xD;
          -  Individuals with a contraindication to MRI, such as the presence of metallic&#xD;
             prostheses or implanted metal device (e.g., infusion pump, defibrillator);&#xD;
&#xD;
          -  Individuals with known clinical conditions that may lead to iron overload including&#xD;
             hemochromatosis, cirrhosis, or sickle cell disease;&#xD;
&#xD;
          -  Individuals with any serious medical condition that the investigator believes may&#xD;
             place them at increased risk for an adverse event.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Srinivas Sridhar, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Theranano LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Ferumoxytol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrovascular Disorders</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/NCT03266848
org study id: R41DA043974
secondary id: R41DA043974
nct id: NCT03266848
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the
      method with first-in-human studies.
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol
      as a contrast agent, and validate the method with first-in-human studies. Subjects who are
      already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion.
      The ferumoxytol infusion itself is not a part of the study. The project will provide brain
      angiograms and establish a human cerebrovascular atlas that will enable future quantitative
      diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that
      characterize disease, a tool which doesn't currently exist, and which could lead to many
      exciting discoveries and clinical applications in neurology.
observational model: Cohort
time perspective: Prospective
measure: Cerebrovascular Angiography
time frame: 0-4 hours after ferumoxytol infusion
description: Obtain angiograms of the cerebral vasculature from the MRI intensity data
measure: Quantitative cerebral blood volume atlas
time frame: 0-4 hours after ferumoxytol infusion
description: Create cerebral blood volume atlas from the quantitative MRI intensity data
intervention type: Diagnostic Test
intervention name: Quantitative Magnetic Resonance Imaging
description: Radiological diagnosis
Subject blood sample before each scan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Srinivas Sridhar, Ph.D.
role: Principal Investigator
affiliation: Theranano LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cerebrovascular Disorders