<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/NCT01731015</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00024828</org_study_id>
    <secondary_id>DIAL1001002</secondary_id>
    <nct_id>NCT01731015</nct_id>
  </id_info>
  <brief_title>Imaging Lung Function Using Oxygen Enhanced MRI</brief_title>
  <official_title>A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hal C Charles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as&#xD;
      an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to&#xD;
      allow an effect size estimate to power future studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label study expanding on work by other groups in animals, ex-vivo human lungs&#xD;
      and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI&#xD;
      comparing images obtained while breathing oxygen to those obtained breathing room air.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
        -  To determine if 1H magnetic resonance images of the human lung and airways can be&#xD;
           obtained in both single breath-hold and gated breathing imaging studies with adequate&#xD;
           signal level and image contrast to extract regional lung functional information with&#xD;
           oxygen as a contrast agent.&#xD;
&#xD;
        -  To determine the short term reproducibility of the lung functional imaging in a subset&#xD;
           of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI&#xD;
           studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Image Quality</measure>
    <time_frame>one exposure</time_frame>
    <description>Assessment of image quality of oxygen enhanced MR images: Signal to Noise Ratio, Dynamic Range of Ratio/Difference Images</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>COPD</condition>
  <condition>Asthma</condition>
  <condition>Cystic Fibrosis</condition>
  <condition>Emphysema</condition>
  <condition>Small Airways Disease</condition>
  <arm_group>
    <arm_group_label>Normal Subject</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with Lung/or Airway Disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medical Grade Oxygen</intervention_name>
    <description>At the study visits, MRI 'studies' will be performed using the same MR scanner (a 3.0-Tesla (T) TRIO MRI system (Siemens Medical Systems)). Lung morphology and function will be acquired using conventional 1H MRI followed by 1H MRI with oxygen as a gaseous contrast agent. For both series the subject will lie down in a supine position on the magnet bed with a standard 1H Torso coil for imaging. Subjects are scanned on room air and then the subjects are switched from room air to 100% oxygen and exhaled O2/CO2 are monitored (Oxigraf Capnograph) until steady state is achieved (in our experience ~ 1-2 minutes). The 100% oxygen MRI imaging is commenced (the average exposure time is usually 5-6 minutes with a maximum exposure of 15 minutes) after which the subjects are switched to room air. After steady state is achieved a second room air scan is completed.</description>
    <arm_group_label>Normal Subject</arm_group_label>
    <arm_group_label>Subjects with Lung/or Airway Disease</arm_group_label>
    <other_name>oxygen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Lung and/or Airway Disease&#xD;
&#xD;
          -  Subjects must meet all of the following inclusion criteria to be eligible for&#xD;
             enrollment into the trial:&#xD;
&#xD;
               1. Subjects must be ≥ 18 years of age;&#xD;
&#xD;
               2. Evidence of lung disease or injury by medical history, physical exam, and/or&#xD;
                  clinical laboratories;&#xD;
&#xD;
                    -  COPD&#xD;
&#xD;
                    -  Asthma&#xD;
&#xD;
                    -  Pre/Post Lung Transplant&#xD;
&#xD;
                    -  Cystic Fibrosis&#xD;
&#xD;
                    -  Emphysema/Other Small Airways Diseases&#xD;
&#xD;
                    -  Lung Transplant&#xD;
&#xD;
               3. Evidence of a personally signed and dated informed consent document indicating&#xD;
                  that the subject has been informed of all pertinent aspects of the trial.&#xD;
&#xD;
               4. Subjects who are willing and able to comply with scheduled visits and other trial&#xD;
                  procedures.&#xD;
&#xD;
        Exclusion Criteria for Subjects with Lung and/or Airway Disease:&#xD;
&#xD;
        Subjects presenting with any of the following will not be included in the trial:&#xD;
&#xD;
          1. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of&#xD;
             contraindications (e.g. metal in the eye, claustrophobia);&#xD;
&#xD;
          2. Unable to receive 100% oxygen by breathing because of potential hypercapnia ( SpO2&#xD;
             &lt;90% or FEV1 &lt; 1 L);&#xD;
&#xD;
          3. Participation in a clinical trial with a study drug that may impact lung function in&#xD;
             the past 14 days; or&#xD;
&#xD;
          4. Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with trial participation or may&#xD;
             interfere with the interpretation of trial results and, in the judgment of the&#xD;
             investigator, would make the subject inappropriate for entry into this trial. This&#xD;
             determination is made by the referring physician based on standard clinical practice.&#xD;
&#xD;
          5. Female; women of childbearing potential must have a confirmed negative urine pregnancy&#xD;
             test on the day of the MR scan, prior to the MRI scan.&#xD;
&#xD;
        Inclusion Criteria for Normal Subjects Subjects must meet all of the following inclusion&#xD;
        criteria to be eligible for enrollment into the trial:&#xD;
&#xD;
          1. Subjects must be ≥ 18 years of age;&#xD;
&#xD;
          2. Non-smokers, ex-smokers with normal pulmonary function test by spirometry;&#xD;
&#xD;
          3. No Evidence of prior lung disease or lung injury by medical history, physical exam,&#xD;
             and/or clinical laboratories;&#xD;
&#xD;
          4. Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the subject has been informed of all pertinent aspects of the trial.&#xD;
&#xD;
          5. Subjects who are willing and able to comply with scheduled visits and other trial&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria for Normal Subjects&#xD;
&#xD;
        Subjects presenting with any of the following will not be included in the trial:&#xD;
&#xD;
          1. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of&#xD;
             contraindications (e.g. metal in the eye, claustrophobia);&#xD;
&#xD;
          2. Unable to receive 100% oxygen by breathing because of potential hypercapnia (SpO2 &lt;90%&#xD;
             or FEV1 &lt; 1 L) (Note, we consider this highly unlikely in a 'normal' subject);&#xD;
&#xD;
          3. Participation in a clinical trial with a study drug that may impact lung function in&#xD;
             the past 14 days; or&#xD;
&#xD;
          4. Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with trial participation or may&#xD;
             interfere with the interpretation of trial results and, in the judgment of the&#xD;
             investigator, would make the subject inappropriate for entry into this trial.&#xD;
&#xD;
          5. Female; women of childbearing potential must have a confirmed negative urine pregnancy&#xD;
             test on the day of the MR scan, prior to the MRI scan.&#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>Cecil Charles, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>Hal C Charles</investigator_full_name>
    <investigator_title>Associate Professor Department of Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Emphysema</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/NCT01731015
org study id: Pro00024828
secondary id: DIAL1001002
nct id: NCT01731015
lead sponsor: 
has dmc: No
The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as
      an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to
      allow an effect size estimate to power future studies.
This is an open label study expanding on work by other groups in animals, ex-vivo human lungs
      and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI
      comparing images obtained while breathing oxygen to those obtained breathing room air.

      Objectives

        -  To determine if 1H magnetic resonance images of the human lung and airways can be
           obtained in both single breath-hold and gated breathing imaging studies with adequate
           signal level and image contrast to extract regional lung functional information with
           oxygen as a contrast agent.

        -  To determine the short term reproducibility of the lung functional imaging in a subset
           of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI
           studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Image Quality
time frame: one exposure
description: Assessment of image quality of oxygen enhanced MR images: Signal to Noise Ratio, Dynamic Range of Ratio/Difference Images
arm group label: Normal Subject
arm group type: Experimental
description: Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.
arm group label: Subjects with Lung/or Airway Disease
arm group type: Experimental
description: Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.
intervention type: Drug
intervention name: Medical Grade Oxygen
description: At the study visits, MRI 'studies' will be performed using the same MR scanner (a 3.0-Tesla (T) TRIO MRI system (Siemens Medical Systems)). Lung morphology and function will be acquired using conventional 1H MRI followed by 1H MRI with oxygen as a gaseous contrast agent. For both series the subject will lie down in a supine position on the magnet bed with a standard 1H Torso coil for imaging. Subjects are scanned on room air and then the subjects are switched from room air to 100% oxygen and exhaled O2/CO2 are monitored (Oxigraf Capnograph) until steady state is achieved (in our experience ~ 1-2 minutes). The 100% oxygen MRI imaging is commenced (the average exposure time is usually 5-6 minutes with a maximum exposure of 15 minutes) after which the subjects are switched to room air. After steady state is achieved a second room air scan is completed.
arm group label: Normal Subject
arm group label: Subjects with Lung/or Airway Disease
other name: oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cecil Charles, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Duke University
investigator full name: Hal C Charles
investigator title: Associate Professor Department of Radiology
mesh term: Cystic Fibrosis
mesh term: Emphysema