<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/NCT02195206</url>
  </required_header>
  <id_info>
    <org_study_id>1000041669</org_study_id>
    <nct_id>NCT02195206</nct_id>
  </id_info>
  <brief_title>Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging: Healthy Adult Volunteer Pilot Study</brief_title>
  <official_title>Development of Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging Hardware and Software: Healthy Adult Volunteer Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this pilot study, MRI of the lungs of healthy adult volunteers will be performed at 3Tesla&#xD;
      to assess image quality using a prototype chest coil and pulse sequence following inhalation&#xD;
      of hyperpolarized 129Xe (xenon) gas. This study will take place at the Hospital for Sick&#xD;
      Children, Toronto, Canada. Thirty two subjects aged 18 to 75 will participate in this study.&#xD;
      Xenon MRI is a non-invasive imaging technique that does not involve X-rays or ionizing&#xD;
      radiation. Rather, this imaging method utilizes the same hardware and software principles&#xD;
      that are used for conventional proton MRI of patients in a hospital. The investigators are&#xD;
      testing the abilities of xenon MRI to see if it will produce lung images of equal or better&#xD;
      quality to that of proton MRI.&#xD;
&#xD;
      The investigators hypothesize that they will get good quality images of the lungs for&#xD;
      analysis using our method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the emergence of novel hardware and software image acquisition improvements, magnetic&#xD;
      resonance imaging (MRI) has the potential to become an important tool for assessing lung&#xD;
      structure and function. In particular, the use of a hyperpolarized noble gas such as 129Xe&#xD;
      has been used to explore structural and functional relationships in the lungs of both healthy&#xD;
      subjects and patients with lung disease (1,2). In contrast to proton-based MRI imaging, 129Xe&#xD;
      gas is used as a &quot;contrast agent&quot; to directly visualize the airways, and thus image&#xD;
      ventilation. Whereas the normal density of gas is too low to produce an easily detectable&#xD;
      signal, this is overcome by artificially increasing the amount of polarization per unit&#xD;
      volume using optical pumping (3).&#xD;
&#xD;
      Hyperpolarized noble gas MR lung imaging is a relatively new imaging method that allows&#xD;
      depiction of both lung function and morphology [4-9]. Hyperpolarized gases are a new class of&#xD;
      MR contrast agent which, when inhaled, provide high temporal and spatial resolution MR images&#xD;
      of the lung airspaces. Since no ionizing radiation is involved, hyperpolarized gas MR imaging&#xD;
      is ideal for the evaluation of lung diseases. With hyperpolarized gases, the nuclear spins of&#xD;
      the gas atoms are brought into alignment outside of the MR scanner via a process called&#xD;
      optical pumping; this yields high polarizations and permits visualization of the lung&#xD;
      airspaces with MR imaging (despite the low physical density of the gas in the lung). Two&#xD;
      non-radioactive (i.e. stable) isotopes of noble gases 3He and 129Xe can be hyperpolarized.&#xD;
      Until recently, higher polarizations could be achieved with 3He than with 129Xe, so in&#xD;
      humans, 3He was more commonly used for hyperpolarized gas MR imaging of the lungs [10-15].&#xD;
      Recently, the technology has been developed to provide large quantities of highly polarized&#xD;
      129Xe [16].&#xD;
&#xD;
      Several applications of 129Xe MRI imaging are under development, including diffusion-weighted&#xD;
      and relaxation-weighted imaging (17-19). These techniques take advantage of the fact that the&#xD;
      rate of loss of 129Xe polarization is significantly influenced by the local blood flow and&#xD;
      concentration of molecular oxygen, as well as the restriction of 129Xe diffusion by small&#xD;
      airway space dimensions. These data can be used to create maps of the lung reflecting&#xD;
      regional ventilation/perfusion and micro-airway sizes. Other data that can be obtained with&#xD;
      129Xe MRI include the volumes of ventilated and unventilated lungs which can subsequently be&#xD;
      analyzed to determine the homogeneity of gas distribution within the airspaces (17).&#xD;
&#xD;
      Objectives of the study are:&#xD;
&#xD;
        -  To quantitatively evaluate a 3T 129Xe chest coil for image quality and coil&#xD;
           comfort/performance.&#xD;
&#xD;
        -  To determine the range of possible novel pulse sequences in combination with the coil&#xD;
           and inhalation of 129Xe gas in healthy volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ventilation Defect Volume</measure>
    <time_frame>Day 1</time_frame>
    <description>Volume of the lung not being ventilated to the optimum level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apparent Diffusion Coefficient</measure>
    <time_frame>Day 1</time_frame>
    <description>Used to obtain structural information of the lung. Metric for assessing tissue damage.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Signal to Noise Ratio</measure>
    <time_frame>Day 1</time_frame>
    <description>Used to assess image quality</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Adult</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Adults from the general population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects male and female aged 18-75&#xD;
&#xD;
          -  Subject has a smoking history of ≤ 1 pack year&#xD;
&#xD;
          -  Subject understands the study procedures and is willing to participate in the study as&#xD;
             indicated by signature on the informed consent&#xD;
&#xD;
          -  Subject must be able to perform a breath hold for 16 seconds&#xD;
&#xD;
          -  Subject has a Body Mass Index (BMI) between 18 and 40&#xD;
&#xD;
          -  Subject is judged to be in stable health on the basis of medical history&#xD;
&#xD;
          -  Subject able to perform reproducible pulmonary function tests (i.e., the 3 best&#xD;
             acceptable spirograms have Forced Expiratory Volume (FEV1) values that do not vary&#xD;
             more than 5% of the largest value or more than 100 ml, whichever is greater)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is, in the opinion of the investigator, mentally or legally incapacitated,&#xD;
             preventing informed consent from being obtained, or cannot read or understand the&#xD;
             written material&#xD;
&#xD;
          -  Subject has a history of chronic or acute respiratory disease&#xD;
&#xD;
          -  Subject has a history of cardiovascular disorders including coronary insufficiency,&#xD;
             cardiac arrhythmias, severe hypertension (≥160 over ≥100)&#xD;
&#xD;
          -  Subject has a daytime room air oxygen saturation ≤ 92% ± 2% while supine&#xD;
&#xD;
          -  Subject is unable to perform spirometry or plethysmography maneuvers&#xD;
&#xD;
          -  Subject is pregnant or lactating&#xD;
&#xD;
          -  In the investigator's opinion, subject suffers from any physical, psychological or&#xD;
             other condition(s) that might prevent performance of the MRI, such as severe&#xD;
             claustrophobia&#xD;
&#xD;
          -  Subject has an MRI incompatible device or any metal in their body which cannot be&#xD;
             removed, including but not limited to pacemakers, neurostimulators, biostimulators,&#xD;
             implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic&#xD;
             fragment or foreign body, shunt, surgical staples (including clips or metallic sutures&#xD;
             and/or ear implants)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giles Santyr, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giles Santyr, PhD</last_name>
    <phone>416-813-7654</phone>
    <phone_ext>301394</phone_ext>
    <email>giles.santyr@sickkids.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sharon Braganza, BSc</last_name>
    <phone>416-813-7654</phone>
    <phone_ext>307937</phone_ext>
    <email>sharon.braganza@sickkids.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Giles Santyr, PhD FCCPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Giles Santyr</investigator_full_name>
    <investigator_title>PhD, FCCPM, Senior Scientist, The Hospital for Sick Children</investigator_title>
  </responsible_party>
  <keyword>Hyperpolarized gas magnetic resonance imaging</keyword>
  <keyword>Hyperpolarized Xenon-129 magnetic resonance imaging</keyword>
  <keyword>Lung Imaging</keyword>
  <keyword>Healthy Adults</keyword>
  <!-- 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/NCT02195206
org study id: 1000041669
nct id: NCT02195206
lead sponsor: 
has dmc: Yes
In this pilot study, MRI of the lungs of healthy adult volunteers will be performed at 3Tesla
      to assess image quality using a prototype chest coil and pulse sequence following inhalation
      of hyperpolarized 129Xe (xenon) gas. This study will take place at the Hospital for Sick
      Children, Toronto, Canada. Thirty two subjects aged 18 to 75 will participate in this study.
      Xenon MRI is a non-invasive imaging technique that does not involve X-rays or ionizing
      radiation. Rather, this imaging method utilizes the same hardware and software principles
      that are used for conventional proton MRI of patients in a hospital. The investigators are
      testing the abilities of xenon MRI to see if it will produce lung images of equal or better
      quality to that of proton MRI.

      The investigators hypothesize that they will get good quality images of the lungs for
      analysis using our method.
With the emergence of novel hardware and software image acquisition improvements, magnetic
      resonance imaging (MRI) has the potential to become an important tool for assessing lung
      structure and function. In particular, the use of a hyperpolarized noble gas such as 129Xe
      has been used to explore structural and functional relationships in the lungs of both healthy
      subjects and patients with lung disease (1,2). In contrast to proton-based MRI imaging, 129Xe
      gas is used as a "contrast agent" to directly visualize the airways, and thus image
      ventilation. Whereas the normal density of gas is too low to produce an easily detectable
      signal, this is overcome by artificially increasing the amount of polarization per unit
      volume using optical pumping (3).

      Hyperpolarized noble gas MR lung imaging is a relatively new imaging method that allows
      depiction of both lung function and morphology [4-9]. Hyperpolarized gases are a new class of
      MR contrast agent which, when inhaled, provide high temporal and spatial resolution MR images
      of the lung airspaces. Since no ionizing radiation is involved, hyperpolarized gas MR imaging
      is ideal for the evaluation of lung diseases. With hyperpolarized gases, the nuclear spins of
      the gas atoms are brought into alignment outside of the MR scanner via a process called
      optical pumping; this yields high polarizations and permits visualization of the lung
      airspaces with MR imaging (despite the low physical density of the gas in the lung). Two
      non-radioactive (i.e. stable) isotopes of noble gases 3He and 129Xe can be hyperpolarized.
      Until recently, higher polarizations could be achieved with 3He than with 129Xe, so in
      humans, 3He was more commonly used for hyperpolarized gas MR imaging of the lungs [10-15].
      Recently, the technology has been developed to provide large quantities of highly polarized
      129Xe [16].

      Several applications of 129Xe MRI imaging are under development, including diffusion-weighted
      and relaxation-weighted imaging (17-19). These techniques take advantage of the fact that the
      rate of loss of 129Xe polarization is significantly influenced by the local blood flow and
      concentration of molecular oxygen, as well as the restriction of 129Xe diffusion by small
      airway space dimensions. These data can be used to create maps of the lung reflecting
      regional ventilation/perfusion and micro-airway sizes. Other data that can be obtained with
      129Xe MRI include the volumes of ventilated and unventilated lungs which can subsequently be
      analyzed to determine the homogeneity of gas distribution within the airspaces (17).

      Objectives of the study are:

        -  To quantitatively evaluate a 3T 129Xe chest coil for image quality and coil
           comfort/performance.

        -  To determine the range of possible novel pulse sequences in combination with the coil
           and inhalation of 129Xe gas in healthy volunteers.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Ventilation Defect Volume
time frame: Day 1
description: Volume of the lung not being ventilated to the optimum level
measure: Apparent Diffusion Coefficient
time frame: Day 1
description: Used to obtain structural information of the lung. Metric for assessing tissue damage.
measure: Signal to Noise Ratio
time frame: Day 1
description: Used to assess image quality
arm group label: Healthy
description: Adult
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Giles Santyr, PhD
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Giles Santyr, PhD
phone: 416-813-7654
phone ext: 301394
email: giles.santyr@sickkids.ca
last name: Sharon Braganza, BSc
phone: 416-813-7654
phone ext: 307937
email: sharon.braganza@sickkids.ca
facility: 
status: Recruiting
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Giles Santyr
investigator title: PhD, FCCPM, Senior Scientist, The Hospital for Sick Children