<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/NCT01697332</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001947</org_study_id>
    <secondary_id>5R01HL096471-04</secondary_id>
    <nct_id>NCT01697332</nct_id>
  </id_info>
  <brief_title>Functional Applications of Hyperpolarized 129Xe MRI</brief_title>
  <official_title>Functional Applications of Hyperpolarized 129Xe MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</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 overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe&#xD;
      MRI to measure lung function and its potential to sensitively detect pulmonary disease and&#xD;
      its progression in COPD. We hypothesize that measurement of alveolar surface area, septal&#xD;
      thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate&#xD;
      better with quality of life measures in COPD subjects than traditional diagnostic measures&#xD;
      such as spirometry and Computed Tomography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding ended prior to resolution of all equipment (polarizer) issues.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</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>Baseline Statistics of Healthy Subjects</measure>
    <time_frame>4 years</time_frame>
    <description>Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences Between Healthy and Diseased COPD Subjects.</measure>
    <time_frame>4 years</time_frame>
    <description>Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatial Heterogeneity</measure>
    <time_frame>4 years</time_frame>
    <description>Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Subjects with and without COPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyperpolarized 129Xe gas</intervention_name>
    <description>800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.</description>
    <arm_group_label>Subjects with and without COPD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20-75&#xD;
&#xD;
        For Healthy nonsmoker subjects:&#xD;
&#xD;
          -  No current physician diagnosed medical disease requiring active medication&#xD;
&#xD;
          -  No smoking history, defined as less than 100 cigarettes smoked in a lifetime&#xD;
&#xD;
          -  Normal spirometry: FEV1/FVC ≥ 0.70, FEV1 ≥ 80% predicted&#xD;
&#xD;
        For Subjects who have participated in the COPDGene Study&#xD;
&#xD;
          -  Post-bronchodilator spirometry: FEV1 &gt; 40% predicted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MR contraindications: e.g., electrical implants such as cardiac pacemakers,&#xD;
             ferromagnetic implants such as prostheses, claustrophobia&#xD;
&#xD;
          -  Pregnancy or suspected pregnancy&#xD;
&#xD;
          -  Use of continuous oxygen&#xD;
&#xD;
          -  Use of antibiotics and/or systemic corticosteroids (new prescription or increased&#xD;
             dose) for an exacerbation of lung disease or any lung infection in the past four weeks&#xD;
&#xD;
          -  Uncontrolled cancer, as defined as ongoing radiation therapy, ongoing chemotherapy&#xD;
&#xD;
          -  A heart attack in the past three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel Patz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>March 19, 2018</results_first_submitted>
  <results_first_submitted_qc>March 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 17, 2018</results_first_posted>
  <last_update_submitted>March 19, 2018</last_update_submitted>
  <last_update_submitted_qc>March 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Samuel Patz</investigator_full_name>
    <investigator_title>Scientific Director, Center for Pulmonary Functional Imaging</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Subjects With and Without COPD</title>
          <description>All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.&#xD;
Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Subjects With and Without COPD</title>
          <description>All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.&#xD;
Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Baseline Statistics of Healthy Subjects</title>
        <description>Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.</description>
        <time_frame>4 years</time_frame>
        <population>No data collected or analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects With and Without COPD</title>
            <description>All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.&#xD;
Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Statistics of Healthy Subjects</title>
          <description>Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.</description>
          <population>No data collected or analyzed for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Differences Between Healthy and Diseased COPD Subjects.</title>
        <description>Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.</description>
        <time_frame>4 years</time_frame>
        <population>No data analyzed or collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects With and Without COPD</title>
            <description>All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.&#xD;
Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.</description>
          </group>
        </group_list>
        <measure>
          <title>Differences Between Healthy and Diseased COPD Subjects.</title>
          <description>Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.</description>
          <population>No data analyzed or collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Spatial Heterogeneity</title>
        <description>Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.</description>
        <time_frame>4 years</time_frame>
        <population>No data analyzed or collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects With and Without COPD</title>
            <description>All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.&#xD;
Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.</description>
          </group>
        </group_list>
        <measure>
          <title>Spatial Heterogeneity</title>
          <description>Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.</description>
          <population>No data analyzed or collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Subjects With and Without COPD</title>
          <description>All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.&#xD;
Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Samuel Patz</name_or_title>
      <organization>Brigham and Women's Hospital</organization>
      <phone>6172780616</phone>
      <email>patz@bwh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01697332
org study id: 2012P001947
secondary id: 5R01HL096471-04
nct id: NCT01697332
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe
      MRI to measure lung function and its potential to sensitively detect pulmonary disease and
      its progression in COPD. We hypothesize that measurement of alveolar surface area, septal
      thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate
      better with quality of life measures in COPD subjects than traditional diagnostic measures
      such as spirometry and Computed Tomography.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Baseline Statistics of Healthy Subjects
time frame: 4 years
description: Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.
measure: Differences Between Healthy and Diseased COPD Subjects.
time frame: 4 years
description: Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.
measure: Spatial Heterogeneity
time frame: 4 years
description: Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.
arm group label: Subjects with and without COPD
arm group type: Experimental
description: All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.
intervention type: Drug
intervention name: Hyperpolarized 129Xe gas
description: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.
arm group label: Subjects with and without COPD
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Samuel Patz, PhD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Samuel Patz
investigator title: Scientific Director, Center for Pulmonary Functional Imaging
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 