<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/NCT02976935</url>
  </required_header>
  <id_info>
    <org_study_id>13104</org_study_id>
    <nct_id>NCT02976935</nct_id>
  </id_info>
  <brief_title>Functional MR Lung Imaging Using Hyperpolarised 129Xe</brief_title>
  <official_title>FUNCTIONAL MAGNETIC RESONANCE LUNG IMAGING USING INHALED HYPERPOLARISED 129Xe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the potential value of a novel imaging technique&#xD;
      (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in&#xD;
      patients with COPD and IPF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acquisition of baseline data and images to investigate use of hp129Xe as a diagnostic tool</measure>
    <time_frame>4 years</time_frame>
    <description>i) Obtain baseline data for each group with matched clinical data (e.g. pulmonary function tests) allowing comparison with existing clinical diagnostic techniques and also determining correlation with disease severity ii) Use the images obtained to set up standard sequencing protocols and define algorithms and inform power calculations for subsequent studies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collation of data regarding ability of participants to adhere to the study protocol</measure>
    <time_frame>4 years</time_frame>
    <description>1) To collate data regarding the ability of participants of each group to adhere to the protocol thus informing the study design of future trials.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>COPD</condition>
  <condition>IPF</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Subjects will receive 1L non-hyperpolarised 129Xenon to inhale. Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath while the MRI scan is performed. Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L). Optional Study Visit #2:Identical to Study Visit 1 but with the further series of inhalations being up to a maximum of 4 (maximum total exposure to hyperpolarised 129Xenon will be 5L).Optional Study Visit #3: Identical to Study Visit 2 (maximum total exposure to hyperpolarised 129Xenon will be 5L)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Obstructive Pulmonary Disease</arm_group_label>
    <description>Subjects will receive 1L bag of non-hyperpolarised 129Xenon to inhale. Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath for required time while the MRI scan is performed.Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L). Optional Study Visit #2: Identical to Study Visit 1 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>hyperpolarised 129 Xenon</intervention_name>
    <description>Hyperpolarised 129 Xe to assess lung function</description>
    <arm_group_label>Chronic Obstructive Pulmonary Disease</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Volunteers, COPD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        General Inclusion criteria&#xD;
&#xD;
          -  Male or Female aged over 18 years.&#xD;
&#xD;
          -  Capacity to give informed consent&#xD;
&#xD;
          -  Normal blood pressure (systolic BP &gt; 100 mmHg and diastolic BP &gt; 70 mmHg)&#xD;
&#xD;
          -  Resting heart rate &gt; 50 bpm&#xD;
&#xD;
          -  For women, negative urinary β-hCG at the screening and subsequent visits&#xD;
&#xD;
          -  Subject able to hold breath for 10 seconds&#xD;
&#xD;
          -  Subject able to fit into 129Xe chest coil used for MRI&#xD;
&#xD;
          -  Subject able to understand the requirements of the study and to cooperate with the&#xD;
             study procedures&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
        HEALTHY VOLUNTEERS&#xD;
&#xD;
        • No significant respiratory disease within the last year&#xD;
&#xD;
        PATIENTS&#xD;
&#xD;
        COPD&#xD;
&#xD;
          -  Evidence of airflow obstruction (FEV/FVC &lt;0.7) and FEV1 &lt;80% predicted post&#xD;
             bronchodilator&#xD;
&#xD;
          -  Minimum FVC 1.5L&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        HEALTHY VOLUNTEERS&#xD;
&#xD;
          -  Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated&#xD;
             following questionnaire)&#xD;
&#xD;
          -  Acute respiratory illness within 30 days of MRI&#xD;
&#xD;
          -  Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI&#xD;
             and administration of 129Xe deemed inappropriate in context of other study&#xD;
&#xD;
          -  Subject deemed unlikely to comply with instructions during imaging&#xD;
&#xD;
          -  Do not meet the inclusion criteria above&#xD;
&#xD;
          -  Subject not deemed fit enough to tolerate procedure&#xD;
&#xD;
          -  Subject deemed unsuitable by clinical investigator for other reasons&#xD;
&#xD;
        PATIENTS&#xD;
&#xD;
          -  Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated&#xD;
             following questionnaire)&#xD;
&#xD;
          -  Acute respiratory illness within 30 days of MRI&#xD;
&#xD;
          -  Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI&#xD;
             and administration of 129Xe deemed inappropriate in context of other study&#xD;
&#xD;
          -  Subject deemed unlikely to comply with instructions during imaging&#xD;
&#xD;
          -  Do not meet the inclusion criteria above&#xD;
&#xD;
          -  Subject not deemed fit enough to tolerate procedure&#xD;
&#xD;
          -  Subject deemed unsuitable by clinical investigator for other reasons&#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>
  <location>
    <facility>
      <name>Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Xenon</mesh_term>
  </intervention_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/NCT02976935
org study id: 13104
nct id: NCT02976935
lead sponsor: 
has dmc: No
The aim of this study is to investigate the potential value of a novel imaging technique
      (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in
      patients with COPD and IPF.
observational model: Cohort
time perspective: Prospective
measure: Acquisition of baseline data and images to investigate use of hp129Xe as a diagnostic tool
time frame: 4 years
description: i) Obtain baseline data for each group with matched clinical data (e.g. pulmonary function tests) allowing comparison with existing clinical diagnostic techniques and also determining correlation with disease severity ii) Use the images obtained to set up standard sequencing protocols and define algorithms and inform power calculations for subsequent studies
measure: Collation of data regarding ability of participants to adhere to the study protocol
time frame: 4 years
description: 1) To collate data regarding the ability of participants of each group to adhere to the protocol thus informing the study design of future trials.
arm group label: Healthy Volunteers
description: Subjects will receive 1L non-hyperpolarised 129Xenon to inhale. Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath while the MRI scan is performed. Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L). Optional Study Visit #2:Identical to Study Visit 1 but with the further series of inhalations being up to a maximum of 4 (maximum total exposure to hyperpolarised 129Xenon will be 5L).Optional Study Visit #3: Identical to Study Visit 2 (maximum total exposure to hyperpolarised 129Xenon will be 5L)
arm group label: Chronic Obstructive Pulmonary Disease
description: Subjects will receive 1L bag of non-hyperpolarised 129Xenon to inhale. Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath for required time while the MRI scan is performed.Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L). Optional Study Visit #2: Identical to Study Visit 1 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L)
intervention type: Other
intervention name: hyperpolarised 129 Xenon
description: Hyperpolarised 129 Xe to assess lung function
arm group label: Chronic Obstructive Pulmonary Disease
arm group label: Healthy Volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Xenon