<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/NCT03776747</url>
  </required_header>
  <id_info>
    <org_study_id>200803776</org_study_id>
    <nct_id>NCT03776747</nct_id>
  </id_info>
  <brief_title>Repeatability in Hyperpolarized 3-Helium With MRI</brief_title>
  <official_title>Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eric A. Hoffman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</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>
      The main purpose of this study is to assess and test the reproducibility and results of&#xD;
      hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the&#xD;
      lungs in healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      New CT imaging techniques often expose the patient to higher doses of radiation. There is a&#xD;
      great deal of concern about effects of medical radiation exposure on the general public and&#xD;
      regulations are becoming stricter on the radiation doses that are allowed.&#xD;
&#xD;
      One novel procedure that has been developed to evaluate the function and structure of the&#xD;
      lung is the use of hyperpolarized gases with MRI scanners. We want to compare the lung&#xD;
      imaging techniques that we have developed in our lab to a technique that uses hyperpolarized&#xD;
      3-Helium gas with MRI. This technique is free from radiation and less invasive than many lung&#xD;
      imaging techniques.&#xD;
&#xD;
      Hyperpolarized gas MRI is based on the introduction of spins into the lungs, allowing imaging&#xD;
      to take place. The use of hyperpolarized 3-Helium has a few advantages:&#xD;
&#xD;
        1. it allows us to see the microstructure of the lungs through diffusion imaging (apparent&#xD;
           diffusion coefficient) which correlates with the size of airways and alveolar space.&#xD;
&#xD;
        2. it allows us to see ventilation, or how air moves in the lungs, at a high resolution.&#xD;
&#xD;
        3. it is capable of ultra fast imaging which will help us assess gas flow patterns within&#xD;
           the airways.&#xD;
&#xD;
      and 4) the speed of depolarization lets us measure the partial pressure of oxygen and&#xD;
      associated gas exchange mechanisms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2008</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apparent diffusion coefficient</measure>
    <time_frame>Through study completion, measurements completed at one day visit only.</time_frame>
    <description>Lung volume inflation levels between left and right lungs</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Radiation Exposure</condition>
  <arm_group>
    <arm_group_label>Group One: Prone MRI Scans</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Two: Supine MRI scans</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prone hyperpolarized 3 helium gas scan</intervention_name>
    <description>Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.</description>
    <arm_group_label>Group One: Prone MRI Scans</arm_group_label>
    <other_name>Prone MRI scan with contrast</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Supine hyperpolarized 3 helium gas scan</intervention_name>
    <description>Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.</description>
    <arm_group_label>Group Two: Supine MRI scans</arm_group_label>
    <other_name>Supine MRI scan with contrast</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Vitals</intervention_name>
    <arm_group_label>Group One: Prone MRI Scans</arm_group_label>
    <arm_group_label>Group Two: Supine MRI scans</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pulmonary Function Tests</intervention_name>
    <description>Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes</description>
    <arm_group_label>Group One: Prone MRI Scans</arm_group_label>
    <arm_group_label>Group Two: Supine MRI scans</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Initial protocol MRI scan</intervention_name>
    <description>Initial scan to determine placement</description>
    <arm_group_label>Group One: Prone MRI Scans</arm_group_label>
    <arm_group_label>Group Two: Supine MRI scans</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must be between the ages of 18 and 90&#xD;
&#xD;
          -  must have a Body Mass Index (BMI) of &lt; 32 and weigh &lt; 200 lbs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if female, must not be pregnant or breastfeeding&#xD;
&#xD;
          -  must not have any metal objects in or on their body including body piercings that&#xD;
             cannot be easily removed, bullets, metallic fragments or slivers in eyes, skin, etc.,&#xD;
             pacemaker or defibrillation, aneurysm clips, cochlear implants, coronary stents, or&#xD;
             neurostimulation.&#xD;
&#xD;
          -  must not have a history of claustrophobia, panic disorders, anxiety attacks, atrial&#xD;
             fibrillation, uncontrolled high blood pressure, frequent ventricular ectopic rhythm,&#xD;
             hemodynamic instability, kidney dysfunction or heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric A Hoffman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Eric A. Hoffman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>December 6, 2022</submitted>
    <returned>December 28, 2022</returned>
    <submitted>May 2, 2023</submitted>
    <returned>May 26, 2023</returned>
  </pending_results>
  <!-- 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/NCT03776747
org study id: 200803776
nct id: NCT03776747
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to assess and test the reproducibility and results of
      hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the
      lungs in healthy adult subjects.
New CT imaging techniques often expose the patient to higher doses of radiation. There is a
      great deal of concern about effects of medical radiation exposure on the general public and
      regulations are becoming stricter on the radiation doses that are allowed.

      One novel procedure that has been developed to evaluate the function and structure of the
      lung is the use of hyperpolarized gases with MRI scanners. We want to compare the lung
      imaging techniques that we have developed in our lab to a technique that uses hyperpolarized
      3-Helium gas with MRI. This technique is free from radiation and less invasive than many lung
      imaging techniques.

      Hyperpolarized gas MRI is based on the introduction of spins into the lungs, allowing imaging
      to take place. The use of hyperpolarized 3-Helium has a few advantages:

        1. it allows us to see the microstructure of the lungs through diffusion imaging (apparent
           diffusion coefficient) which correlates with the size of airways and alveolar space.

        2. it allows us to see ventilation, or how air moves in the lungs, at a high resolution.

        3. it is capable of ultra fast imaging which will help us assess gas flow patterns within
           the airways.

      and 4) the speed of depolarization lets us measure the partial pressure of oxygen and
      associated gas exchange mechanisms.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Apparent diffusion coefficient
time frame: Through study completion, measurements completed at one day visit only.
description: Lung volume inflation levels between left and right lungs
arm group label: Group One: Prone MRI Scans
arm group type: Experimental
description: Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
arm group label: Group Two: Supine MRI scans
arm group type: Active Comparator
description: Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
intervention type: Drug
intervention name: Prone hyperpolarized 3 helium gas scan
description: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
arm group label: Group One: Prone MRI Scans
other name: Prone MRI scan with contrast
intervention type: Drug
intervention name: Supine hyperpolarized 3 helium gas scan
description: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
arm group label: Group Two: Supine MRI scans
other name: Supine MRI scan with contrast
intervention type: Diagnostic Test
intervention name: Vitals
arm group label: Group One: Prone MRI Scans
arm group label: Group Two: Supine MRI scans
intervention type: Diagnostic Test
intervention name: Pulmonary Function Tests
description: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
arm group label: Group One: Prone MRI Scans
arm group label: Group Two: Supine MRI scans
intervention type: Diagnostic Test
intervention name: Initial protocol MRI scan
description: Initial scan to determine placement
arm group label: Group One: Prone MRI Scans
arm group label: Group Two: Supine MRI scans
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric A Hoffman, PhD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Eric A. Hoffman
investigator title: Professor
submitted: December 6, 2022
returned: December 28, 2022
submitted: May 2, 2023
returned: May 26, 2023