<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/NCT02995590</url>
  </required_header>
  <id_info>
    <org_study_id>19112</org_study_id>
    <nct_id>NCT02995590</nct_id>
  </id_info>
  <brief_title>Assessing Deformable Image Registration in the Lung Using Hyperpolarized-gas MRI</brief_title>
  <official_title>Assessing Deformable Image Registration in the Lung Using Hyperpolarized-gas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic&#xD;
      Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively&#xD;
      measuring physiological lung deformation on a regional basis. This unique imaging technique&#xD;
      holds great promise for assessing, validating, and improving the use of Deformable image&#xD;
      Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas&#xD;
      tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for&#xD;
      the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this&#xD;
      application is to optimize the hyperpolarized helium tagging MRI technology and establish its&#xD;
      usefulness for DIR assessment.&#xD;
&#xD;
      Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D)&#xD;
      hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung&#xD;
      deformation between inhalation and exhalation. Our second objective is to develop&#xD;
      physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy&#xD;
      subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be&#xD;
      used to evaluate a range different DIR algorithms, by comparing the errors between the&#xD;
      DIR-derived deformation vector fields and the ground truth represented in the digital&#xD;
      phantom. Successful completion of these aims will yield a novel methodology for DIR&#xD;
      assessment in the lung for radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to develop new ways to make medical images of the lungs and&#xD;
      liver of adults using a technique called four-dimensional magnetic resonance imaging&#xD;
      (4D-MRI). This technique produces three-dimensional movies of the inside of the chest and&#xD;
      abdomen while the patient is breathing. (The fourth dimension is time!)&#xD;
&#xD;
      This new way of medical imaging is being developed to help cancer patients undergoing&#xD;
      radiation therapy. Radiation therapy is used to treat cancerous tumors. For radiation therapy&#xD;
      to be effective, the precise size, shape, and location of the tumor within the body must be&#xD;
      known. A particular difficulty for radiation treatment of lung and liver cancer is that the&#xD;
      tumor moves during treatment because the patient is breathing. Therefore, tumor motion must&#xD;
      also be incorporated into the treatment plan. This study aims to improve radiation treatment&#xD;
      planning through better targeting and dose estimation based on 4D-MRI. Before this new&#xD;
      imaging method can be used for radiation treatment planning, it must be tested in living,&#xD;
      breathing volunteers.&#xD;
&#xD;
      You are being asked to take part in a research study because you are a cancer patient or a&#xD;
      healthy volunteer. You do not have to take part in this study. You should only agree to take&#xD;
      part in this study after reading this consent form and discussing it with the study team. You&#xD;
      may also discuss this with your family, friends, health care providers or others before you&#xD;
      make a decision.&#xD;
&#xD;
      Though you may not be directly helped by being in this study, the information gained by doing&#xD;
      this study may help others in the future. You might not want to take part in this study&#xD;
      because of the temporary risk of discomfort during the time the subject is asked to lie still&#xD;
      in the confined space of the MRI scanner. This discomfort may include claustrophobia (fear of&#xD;
      being in a small space), feelings of warmth, muscle twitching due to excited nerves, and&#xD;
      exposure to loud thumping noises produced by the MR scanner. If you are pregnant or think you&#xD;
      may be pregnant, if would not be safe for you to be in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Anticipated">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2019</primary_completion_date>
  <phase>Phase 1</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Aim 1</measure>
    <time_frame>At time of MRI</time_frame>
    <description>The difference between the deformation vector field derived from a given DIR algorithm (dDVF) and the known deformation vector field of the digital phantom (pDVF).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aim 2</measure>
    <time_frame>At time of MRI</time_frame>
    <description>The Relationship between the DVF errors and motion amplitude.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aim 3</measure>
    <time_frame>At time of MRI</time_frame>
    <description>The relationship between the DVF and lung feature richness</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>MRI of lung motion during breathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A medical history will be obtained defining any present and past history of respiratory illnesses, medications, and hospitalizations and the ability to have MR imaging.&#xD;
A urine pregnancy test will be done for women of childbearing potential, who report the possibility that they might be pregnant.&#xD;
Before and after MR imaging, a physical exam, spirometry, and a baseline %PO2 will be performed.&#xD;
During the MR imaging procedure, the subject's heart rate and blood oxygen saturation will be monitored using an MR compatible pulse oximeter.&#xD;
Once positioned in the MR scanner, conventional proton images of the thorax will be obtained to define the lung boundaries for subsequent image alignment. -Free breathing conventional MR imaging will be performed.&#xD;
Hyperpolarized helium 3 imaging will be performed at breath hold.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyperpolarized He3</intervention_name>
    <description>Hyperpolarized Helium can be used as a Contrast Agent for Lung Images using MRI.</description>
    <arm_group_label>MRI of lung motion during breathing</arm_group_label>
    <other_name>Helium study</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects must be willing to participate and undergo the procedure, and be&#xD;
             manageable as out-patients.&#xD;
&#xD;
          -  Normal Subjects: Currently feeling well without respiratory symptoms.&#xD;
&#xD;
          -  No history of lung disease.&#xD;
&#xD;
          -  Never personally smoked (defined as less 100 cigarettes in their lifetime).&#xD;
             -Secondhand smoke exposure is not an exclusion criterion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of&#xD;
             imaging.&#xD;
&#xD;
          -  FEV1 percent predicted less than 80%.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign&#xD;
             bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any&#xD;
             implanted device that cannot be verified as MRI compliant will be excluded.&#xD;
&#xD;
          -  Chest circumference greater than that of the xenon MR and/or helium coil. The&#xD;
             circumference of the coil is approximately 42 inches.&#xD;
&#xD;
          -  History of congenital cardiac disease, chronic renal failure, or cirrhosis.&#xD;
&#xD;
          -  Inability to understand simple instructions or to hold still for approximately 10&#xD;
             seconds.&#xD;
&#xD;
          -  History of respiratory infection within 2 weeks prior to the MR scan&#xD;
&#xD;
          -  History of MI, stroke and/or poorly controlled hypertension.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yun M Shim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roselove Asare, BSRT</last_name>
    <phone>434-243-6074</phone>
    <email>rnn3b@virginia.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roselove Asare, RT</last_name>
      <phone>434-243-6074</phone>
      <email>rnn3b@virginia.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Y. Michael Shim, MD</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02995590
org study id: 19112
nct id: NCT02995590
lead sponsor: 
has dmc: No
Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic
      Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively
      measuring physiological lung deformation on a regional basis. This unique imaging technique
      holds great promise for assessing, validating, and improving the use of Deformable image
      Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas
      tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for
      the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this
      application is to optimize the hyperpolarized helium tagging MRI technology and establish its
      usefulness for DIR assessment.

      Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D)
      hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung
      deformation between inhalation and exhalation. Our second objective is to develop
      physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy
      subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be
      used to evaluate a range different DIR algorithms, by comparing the errors between the
      DIR-derived deformation vector fields and the ground truth represented in the digital
      phantom. Successful completion of these aims will yield a novel methodology for DIR
      assessment in the lung for radiotherapy.
The purpose of this study is to develop new ways to make medical images of the lungs and
      liver of adults using a technique called four-dimensional magnetic resonance imaging
      (4D-MRI). This technique produces three-dimensional movies of the inside of the chest and
      abdomen while the patient is breathing. (The fourth dimension is time!)

      This new way of medical imaging is being developed to help cancer patients undergoing
      radiation therapy. Radiation therapy is used to treat cancerous tumors. For radiation therapy
      to be effective, the precise size, shape, and location of the tumor within the body must be
      known. A particular difficulty for radiation treatment of lung and liver cancer is that the
      tumor moves during treatment because the patient is breathing. Therefore, tumor motion must
      also be incorporated into the treatment plan. This study aims to improve radiation treatment
      planning through better targeting and dose estimation based on 4D-MRI. Before this new
      imaging method can be used for radiation treatment planning, it must be tested in living,
      breathing volunteers.

      You are being asked to take part in a research study because you are a cancer patient or a
      healthy volunteer. You do not have to take part in this study. You should only agree to take
      part in this study after reading this consent form and discussing it with the study team. You
      may also discuss this with your family, friends, health care providers or others before you
      make a decision.

      Though you may not be directly helped by being in this study, the information gained by doing
      this study may help others in the future. You might not want to take part in this study
      because of the temporary risk of discomfort during the time the subject is asked to lie still
      in the confined space of the MRI scanner. This discomfort may include claustrophobia (fear of
      being in a small space), feelings of warmth, muscle twitching due to excited nerves, and
      exposure to loud thumping noises produced by the MR scanner. If you are pregnant or think you
      may be pregnant, if would not be safe for you to be in this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Aim 1
time frame: At time of MRI
description: The difference between the deformation vector field derived from a given DIR algorithm (dDVF) and the known deformation vector field of the digital phantom (pDVF).
measure: Aim 2
time frame: At time of MRI
description: The Relationship between the DVF errors and motion amplitude.
measure: Aim 3
time frame: At time of MRI
description: The relationship between the DVF and lung feature richness
arm group label: MRI of lung motion during breathing
arm group type: Experimental
description: A medical history will be obtained defining any present and past history of respiratory illnesses, medications, and hospitalizations and the ability to have MR imaging.
A urine pregnancy test will be done for women of childbearing potential, who report the possibility that they might be pregnant.
Before and after MR imaging, a physical exam, spirometry, and a baseline %PO2 will be performed.
During the MR imaging procedure, the subject's heart rate and blood oxygen saturation will be monitored using an MR compatible pulse oximeter.
Once positioned in the MR scanner, conventional proton images of the thorax will be obtained to define the lung boundaries for subsequent image alignment. -Free breathing conventional MR imaging will be performed.
Hyperpolarized helium 3 imaging will be performed at breath hold.
intervention type: Drug
intervention name: Hyperpolarized He3
description: Hyperpolarized Helium can be used as a Contrast Agent for Lung Images using MRI.
arm group label: MRI of lung motion during breathing
other name: Helium study
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yun M Shim, MD
role: Principal Investigator
affiliation: University of Virginia
last name: Roselove Asare, BSRT
phone: 434-243-6074
email: rnn3b@virginia.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Y. Michael Shim, MD
investigator title: Associate Professor of Medicine
sharing ipd: No