<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/NCT01710449</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00015170</org_study_id>
    <secondary_id>DIAL1001001</secondary_id>
    <nct_id>NCT01710449</nct_id>
  </id_info>
  <brief_title>Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen</brief_title>
  <official_title>Evaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen.</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>
      An open label study in 40-60 subjects with diagnosed lung airway disease and in 10-20 normal&#xD;
      controls. Each subject will receive PFP as a contrast agent to visualize the airway and&#xD;
      alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to evaluate the utilization of conventional 'thermally' polarized&#xD;
      perfluorinated gas mixed with oxygen as an exogenous inert contrast agent to image the airway&#xD;
      spaces in normal and diseased human lungs. This is an open label proof of concept study&#xD;
      expanding on work by other groups in animals and ex-vivo human lungs and on studies in human&#xD;
      subjects with such gases. Projection images (2-dimensional) and 3D images will be obtained&#xD;
      using 19F MRI coupled with spirometry breathing maneuvers to correlate spirometry variables&#xD;
      (e.g. FEV1 and FEV1/FVC) with regional distribution of the gas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 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>MRI image quality of Perfluorinated Gas imaging of the lung</measure>
    <time_frame>Single exposure</time_frame>
    <description>Identify Image quality characteristics related to lung function characterized by 19F MRI.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>COPD</condition>
  <condition>Asthma</condition>
  <condition>Cystic Fibrosis</condition>
  <condition>Emphysema</condition>
  <condition>Small Airways Diseases</condition>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lung Disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>perfluorinated gas/oxygen mixture</intervention_name>
    <description>Subjects are imaged with MRI one time in an proof of concept study for the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.</description>
    <arm_group_label>Lung Disease</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subjects with Lung and/or Airway Disease&#xD;
&#xD;
        -Inclusion Criteria&#xD;
&#xD;
        Subjects must meet all of the following inclusion criteria to be eligible for enrollment&#xD;
        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 clinical&#xD;
             laboratories;&#xD;
&#xD;
               1. COPD&#xD;
&#xD;
               2. Asthma&#xD;
&#xD;
               3. Cystic Fibrosis&#xD;
&#xD;
               4. Emphysema/Other Small Airways Diseases&#xD;
&#xD;
               5. Lung Transplant&#xD;
&#xD;
          3. 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;
          4. Subjects who are willing and able to comply with scheduled visits and other trial&#xD;
             procedures.&#xD;
&#xD;
               -  Exclusion Criteria&#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 gas mixture by breathing because of contraindications;&#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;
&#xD;
        Normal Subjects&#xD;
&#xD;
        -Inclusion Criteria&#xD;
&#xD;
        Subjects must meet all of the following inclusion criteria to be eligible for enrollment&#xD;
        into the trial:&#xD;
&#xD;
          1. Subjects must be ≥ 18 years of age;&#xD;
&#xD;
          2. Non-smokers;&#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&#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 gas mixture by breathing because of contraindications;&#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>N/A</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 2013</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>December 5, 2013</last_update_submitted>
  <last_update_submitted_qc>December 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2013</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>
  <keyword>Lung Transplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Pulmonary Emphysema</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>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/NCT01710449
org study id: Pro00015170
secondary id: DIAL1001001
nct id: NCT01710449
lead sponsor: 
has dmc: No
An open label study in 40-60 subjects with diagnosed lung airway disease and in 10-20 normal
      controls. Each subject will receive PFP as a contrast agent to visualize the airway and
      alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures.
The goal of this study is to evaluate the utilization of conventional 'thermally' polarized
      perfluorinated gas mixed with oxygen as an exogenous inert contrast agent to image the airway
      spaces in normal and diseased human lungs. This is an open label proof of concept study
      expanding on work by other groups in animals and ex-vivo human lungs and on studies in human
      subjects with such gases. Projection images (2-dimensional) and 3D images will be obtained
      using 19F MRI coupled with spirometry breathing maneuvers to correlate spirometry variables
      (e.g. FEV1 and FEV1/FVC) with regional distribution of the gas.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: MRI image quality of Perfluorinated Gas imaging of the lung
time frame: Single exposure
description: Identify Image quality characteristics related to lung function characterized by 19F MRI.
arm group label: Normal
arm group type: Experimental
description: The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.
arm group label: Lung Disease
arm group type: Experimental
description: The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.
intervention type: Drug
intervention name: perfluorinated gas/oxygen mixture
description: Subjects are imaged with MRI one time in an proof of concept study for the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.
arm group label: Lung Disease
arm group label: Normal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Asthma
mesh term: Pulmonary Emphysema
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Fibrosis
mesh term: Emphysema