xml: <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/NCT06038630</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00113114</org_study_id>
      <nct_id>NCT06038630</nct_id>
    </id_info>
    <brief_title>129Xe MRI Cardiopulmonary</brief_title>
    <official_title>129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bastiaan Driehuys</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe&#xD;
        gas exchange MRI and to understand how they change in response to interventions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study focuses on the markers that are derived from the interaction of 129Xe with&#xD;
        pulmonary capillary red blood cells (RBCs). Specifically, the investigators focus on RBC&#xD;
        transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC&#xD;
        chemical shift.&#xD;
  &#xD;
        In addition to healthy volunteers, the population to be studied will consist of patients&#xD;
        scheduled to undergo either transfusion or phlebotomy, those with a physician diagnosis of&#xD;
        interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), non-specific&#xD;
        interstitial pneumonias (NSIP), chronic hypersensitivity pneumonitis (cHP), and sarcoid, as&#xD;
        well as those with either chronic thromboembolic pulmonary hypertension (CTEPH) and acute&#xD;
        pulmonary embolism.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2028</primary_completion_date>
    <phase>Phase 2</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>Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis</measure>
      <time_frame>Up to 5 days pre/post transfusion or apheresis</time_frame>
      <description>The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in RBC (red blood cell) Chemical Shift After Oxygen Administration</measure>
      <time_frame>Baseline, 1 day</time_frame>
      <description>To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in RBC Oscillation Amplitude Post Therapy</measure>
      <time_frame>Baseline, 3-6 months post-treatment</time_frame>
      <description>Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">125</enrollment>
    <condition>Interstitial Lung Disease</condition>
    <condition>Chronic Thromboembolic Pulmonary Hypertension</condition>
    <condition>Acute Pulmonary Embolism</condition>
    <condition>Anemia</condition>
    <condition>Polycythemia</condition>
    <arm_group>
      <arm_group_label>Transfusion and Phlebotomy Patients</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Oxygen Administration Patients</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or are a healthy volunteer.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Acute or Chronic Pulmonary Embolism Patients</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Individuals recently diagnosed with a blood clot in their lungs.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hyperpolarized Xe129</intervention_name>
      <description>Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds.</description>
      <arm_group_label>Acute or Chronic Pulmonary Embolism Patients</arm_group_label>
      <arm_group_label>Oxygen Administration Patients</arm_group_label>
      <arm_group_label>Transfusion and Phlebotomy Patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Oxygen Administration</intervention_name>
      <description>Oxygen administration</description>
      <arm_group_label>Oxygen Administration Patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for Healthy Volunteers:&#xD;
  &#xD;
          (Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be&#xD;
          eligible for enrollment into the trial)&#xD;
  &#xD;
            1. Outpatients of either gender, age &gt; 18&#xD;
  &#xD;
            2. Willing and able to give informed consent and adhere to visit/protocol (Consent must&#xD;
               be given before any study procedures are performed.)&#xD;
  &#xD;
            3. Subject has no diagnosed pulmonary conditions&#xD;
  &#xD;
            4. Subject has not smoked in the previous 5 years&#xD;
  &#xD;
            5. Smoking history, if any, is less than or equal to 5 pack-years&#xD;
  &#xD;
            6. No history of using other inhaled products more than 1/week for &gt; 1 year&#xD;
  &#xD;
          Inclusion Criteria for Transfusion and Phlebotomy Patients:&#xD;
  &#xD;
            1. In-patient or outpatients of either sex, age &gt; 18&#xD;
  &#xD;
            2. Willing and able to give informed consent and adhere to visit/protocol&#xD;
  &#xD;
          And one of the following:&#xD;
  &#xD;
            1. Patients who are scheduled to receive a red cell transfusion for anemia.&#xD;
  &#xD;
            2. Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis&#xD;
               or polycythemia&#xD;
  &#xD;
            3. Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer&#xD;
               inclusion criteria noted above)&#xD;
  &#xD;
          Inclusion Criteria for Oxygen Administration Patients:&#xD;
  &#xD;
            1. In-patient or outpatients of either sex, age &gt; 18&#xD;
  &#xD;
            2. Willing and able to give informed consent and adhere to visit/protocol&#xD;
  &#xD;
          And one of the following categories (ILD, CTEPH, or Healthy):&#xD;
  &#xD;
            1. Interstitial Lung Disease&#xD;
  &#xD;
                 -  Physician diagnosis of Interstitial Lung Disease by a pulmonologist using&#xD;
                    established criteria&#xD;
  &#xD;
               OR&#xD;
  &#xD;
            2. Chronic Thromboembolic Pulmonary Hypertension (CTEPH)&#xD;
  &#xD;
                 -  Patients with a diagnosis of CTEPH, defined as mean PA pressure &gt;20 mmHg with a&#xD;
                    pulmonary vascular resistance &gt;2 WU and pulmonary capillary wedge pressure ≤15&#xD;
                    mmHg at right heart catheterization with evidence of chronic thromboembolic&#xD;
                    disease on clinical imaging after 3 months of anticoagulation&#xD;
  &#xD;
                 -  Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to&#xD;
                    re-turn 3-6 months after for optional follow-up scans&#xD;
  &#xD;
               OR&#xD;
  &#xD;
            3. Healthy Volunteer (criteria noted above)&#xD;
  &#xD;
          Inclusion Criteria for Acute or Chronic Pulmonary Embolism Patients:&#xD;
  &#xD;
            1. In-patient or outpatients of either sex, age &gt; 18&#xD;
  &#xD;
            2. Willing and able to give informed consent and adhere to visit/protocol&#xD;
  &#xD;
          And one of the following categories (Acute or Chronic)&#xD;
  &#xD;
            1. Acute Pulmonary Embolism&#xD;
  &#xD;
                 -  Patients presenting with acute PE 24-48hrs post-admission&#xD;
  &#xD;
                 -  Willing to return after 3-6 months of anti-coagulation therapy&#xD;
  &#xD;
               OR&#xD;
  &#xD;
            2. Chronic Thromboembolic Pulmonary Hypertension (CTEPH)&#xD;
  &#xD;
                 -  Patients with a diagnosis of CTEPH, defined as mean PA pressure &gt;20 mmHg with a&#xD;
                    pulmonary vascular resistance &gt;2 WU and pulmonary capillary wedge pressure ≤15&#xD;
                    mmHg at right heart catheterization with evidence of chronic thromboembolic&#xD;
                    disease on clinical imaging after 3 months of anticoagulation&#xD;
  &#xD;
                 -  Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to&#xD;
                    re-turn 3-6 months after for optional follow-up scans&#xD;
  &#xD;
          Exclusion Criteria for All subjects:&#xD;
  &#xD;
          Subjects presenting with any of the following will not be included in the trial:&#xD;
  &#xD;
            1. MRI is contraindicated based on responses to MRI screening questionnaire&#xD;
  &#xD;
            2. Subject is pregnant or lactating&#xD;
  &#xD;
            3. Resting O2 saturation &lt;90% with maximum supplemental O2 delivered by nasal canula&#xD;
  &#xD;
            4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI&#xD;
  &#xD;
            5. Subject has history of any known ventricular cardiac arrhythmia&#xD;
  &#xD;
            6. Subject has history of cardiac arrest within the last year&#xD;
  &#xD;
            7. Subject does not fit into 129Xe vest coil used for MRI&#xD;
  &#xD;
            8. Subject cannot hold his/her breath for 10 seconds&#xD;
  &#xD;
            9. Subject deemed unlikely to be able to comply with instructions during imaging&#xD;
  &#xD;
           10. Medical or psychological conditions which, in the opinion of the investigator, might&#xD;
               create undue risk to the subject or interfere with the subject's ability to comply&#xD;
               with the protocol requirements&#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>Joseph Mammarappallil, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bastiaan Driehuys, PhD</last_name>
      <phone>919-684-7786</phone>
      <email>bastiaan.driehuys@duke.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Duke University Medical Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Cody Blanton</last_name>
        <phone>919-668-7575</phone>
        <email>cody.blanton@duke.edu</email>
      </contact>
      <contact_backup>
        <last_name>Jennifer Korzekwinski</last_name>
        <phone>919-681-7362</phone>
        <email>jennifer.korzekwinski@duke.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Joseph Mammarappallil, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Bastiaan Driehuys, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Duke University</investigator_affiliation>
      <investigator_full_name>Bastiaan Driehuys</investigator_full_name>
      <investigator_title>Professor of Radiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Hypertension, Pulmonary</mesh_term>
      <mesh_term>Pulmonary Embolism</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</mesh_term>
      <mesh_term>Embolism</mesh_term>
      <mesh_term>Polycythemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>In all instances we will adhere to the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources for Recipients of NIH Grants and Contracts on Obtaining (https://grants.nih.gov/policy/sharing.htm) and Disseminating Biomedical Research Re-sources (issued December 1999). However, we intend to greatly exceed these requirements, making as much of our work freely available to the broader research community either before, or immediately after publication of manuscripts, as well as through PubMedCentral. While we will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.</ipd_time_frame>
      <ipd_access_criteria>We are committed to making de-identified datasets and image analysis available to qualified investigators. When required scientifically, data including identifiers will be shared under an agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data appropriately; and (3) a commitment to destroying or returning the data after analyses are completed.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038630
  org study id: Pro00113114
  nct id: NCT06038630
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe
        gas exchange MRI and to understand how they change in response to interventions.
  This study focuses on the markers that are derived from the interaction of 129Xe with
        pulmonary capillary red blood cells (RBCs). Specifically, the investigators focus on RBC
        transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC
        chemical shift.
  
        In addition to healthy volunteers, the population to be studied will consist of patients
        scheduled to undergo either transfusion or phlebotomy, those with a physician diagnosis of
        interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), non-specific
        interstitial pneumonias (NSIP), chronic hypersensitivity pneumonitis (cHP), and sarcoid, as
        well as those with either chronic thromboembolic pulmonary hypertension (CTEPH) and acute
        pulmonary embolism.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis
  time frame: Up to 5 days pre/post transfusion or apheresis
  description: The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.
  measure: Change in RBC (red blood cell) Chemical Shift After Oxygen Administration
  time frame: Baseline, 1 day
  description: To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).
  measure: Change in RBC Oscillation Amplitude Post Therapy
  time frame: Baseline, 3-6 months post-treatment
  description: Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.
  arm group label: Transfusion and Phlebotomy Patients
  arm group type: Active Comparator
  description: Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.
  arm group label: Oxygen Administration Patients
  arm group type: Active Comparator
  description: Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or are a healthy volunteer.
  arm group label: Acute or Chronic Pulmonary Embolism Patients
  arm group type: Active Comparator
  description: Individuals recently diagnosed with a blood clot in their lungs.
  intervention type: Drug
  intervention name: Hyperpolarized Xe129
  description: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds.
  arm group label: Acute or Chronic Pulmonary Embolism Patients
  arm group label: Oxygen Administration Patients
  arm group label: Transfusion and Phlebotomy Patients
  intervention type: Other
  intervention name: Oxygen Administration
  description: Oxygen administration
  arm group label: Oxygen Administration Patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joseph Mammarappallil, MD
  role: Principal Investigator
  affiliation: Duke University
  last name: Bastiaan Driehuys, PhD
  phone: 919-684-7786
  email: bastiaan.driehuys@duke.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Duke University
  investigator full name: Bastiaan Driehuys
  investigator title: Professor of Radiology
  mesh term: Lung Diseases
  mesh term: Hypertension, Pulmonary
  mesh term: Pulmonary Embolism
  mesh term: Lung Diseases, Interstitial
  mesh term: Embolism
  mesh term: Polycythemia
  sharing ipd: Yes
  ipd description: A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: In all instances we will adhere to the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources for Recipients of NIH Grants and Contracts on Obtaining (https://grants.nih.gov/policy/sharing.htm) and Disseminating Biomedical Research Re-sources (issued December 1999). However, we intend to greatly exceed these requirements, making as much of our work freely available to the broader research community either before, or immediately after publication of manuscripts, as well as through PubMedCentral. While we will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.
  ipd access criteria: We are committed to making de-identified datasets and image analysis available to qualified investigators. When required scientifically, data including identifiers will be shared under an agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data appropriately; and (3) a commitment to destroying or returning the data after analyses are completed.