<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/NCT03764163</url>
  </required_header>
  <id_info>
    <org_study_id>199708651</org_study_id>
    <secondary_id>5R01HL064368</secondary_id>
    <nct_id>NCT03764163</nct_id>
  </id_info>
  <brief_title>Image and Model Based Analysis of Lung Disease</brief_title>
  <official_title>Image and Model Based Analysis of Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eric A. Hoffman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to develop CT scanning and image analysis techniques to&#xD;
      help define and measure several key properties of the pulmonary system that cannot be&#xD;
      obtained by other tests or exams.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specifically, the investigators are interested in understanding the difference between the&#xD;
      normal aging process and the events that lead to emphysema. Additionally, the investigators&#xD;
      are interested in understanding the earliest signs (lung inflammation) of the disease process&#xD;
      leading to three lung diseases, which include emphysema, fibrosis and sarcoidosis; all of&#xD;
      which are described as &quot;inflammatory lung diseases.&quot; The investigators will be using the data&#xD;
      from this study to help define the normal values for the measured properties as well as&#xD;
      deviation from normal values in smokers without defined lung disease and patients with&#xD;
      inflammatory lung disease. The investigators believe that the analysis and scanning&#xD;
      techniques being developed as part of this research will provide new and previously&#xD;
      unavailable information on normal and diseased lungs so that ultimately the investigators can&#xD;
      detect specific changes in the lungs due to a disease and measure any improvements in the&#xD;
      anatomy and/or function of the pulmonary system after a patient has undergone treatment. This&#xD;
      study involves research using X-Ray computed tomography (CT) scanner, which is similar to&#xD;
      previous CT scanners but operates much faster and provides finer image detail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 1997</start_date>
  <completion_date type="Actual">June 5, 2015</completion_date>
  <primary_completion_date type="Actual">June 5, 2015</primary_completion_date>
  <phase>Early 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Normal lung aging assessed by CT imaging</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Normal aging process of the lungs compared to common smoking related lung diseases.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">341</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Study Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pulmonary Function Test</intervention_name>
    <description>Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes</description>
    <arm_group_label>Study Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CT Scans</intervention_name>
    <description>volume scans, perfusion scan, ventilation scan</description>
    <arm_group_label>Study Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire</description>
    <arm_group_label>Study Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>proton scans, hyperpolarized 3-Helium scan</description>
    <arm_group_label>Study Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Xenon gas</intervention_name>
    <description>ventilation CT scans</description>
    <arm_group_label>Study Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non smokers, age 20-29, 40-49, 60-69, 80-89, cannot have smoked more than 20&#xD;
             cigarettes in their lifetime&#xD;
&#xD;
          -  Smokers, age 20-29, 40-49, 60-69, 80-89, currently smoking a minimum of 1 pack (20&#xD;
             cigarettes) per day, normal smokers and mild to moderate Chronic Obstructive Pulmonary&#xD;
             Disease (COPD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies - no allergies to shellfish, eggs, iodine&#xD;
&#xD;
          -  Medications - no medications (except for birth control) for in the 'normal' category&#xD;
&#xD;
          -  No asthma - as self reported&#xD;
&#xD;
          -  BMI (Body Mass Index) - must not exceed 32 or 100kg of weight&#xD;
&#xD;
          -  No other radiology studies in the last 12 months&#xD;
&#xD;
          -  No metal in lung field - no metal from larynx to stomach&#xD;
&#xD;
          -  No known heart disease&#xD;
&#xD;
          -  No known kidney disease or diabetes&#xD;
&#xD;
          -  Must not be pregnant - subjects of childbearing potential with be given a urine&#xD;
             pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric A Hoffman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>March 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Eric A. Hoffman</investigator_full_name>
    <investigator_title>Professor</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>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Xenon</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>CT images will be shared including non-contrast images at TLC, FRC and RV as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be made available starting 6 months after publication of the primary results of each aim</ipd_time_frame>
    <ipd_access_criteria>Data will be provided to academic-based researchers upon written request to the PI, Eric A. Hoffman, PhD. A nominal charge will be made for the time it takes for a technician to prepare and transfer the requested data. This costs will not exceed $250. This service will be available for a minimum of 2 years of study close.</ipd_access_criteria>
  </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/NCT03764163
org study id: 199708651
secondary id: 5R01HL064368
nct id: NCT03764163
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this research study is to develop CT scanning and image analysis techniques to
      help define and measure several key properties of the pulmonary system that cannot be
      obtained by other tests or exams.
Specifically, the investigators are interested in understanding the difference between the
      normal aging process and the events that lead to emphysema. Additionally, the investigators
      are interested in understanding the earliest signs (lung inflammation) of the disease process
      leading to three lung diseases, which include emphysema, fibrosis and sarcoidosis; all of
      which are described as "inflammatory lung diseases." The investigators will be using the data
      from this study to help define the normal values for the measured properties as well as
      deviation from normal values in smokers without defined lung disease and patients with
      inflammatory lung disease. The investigators believe that the analysis and scanning
      techniques being developed as part of this research will provide new and previously
      unavailable information on normal and diseased lungs so that ultimately the investigators can
      detect specific changes in the lungs due to a disease and measure any improvements in the
      anatomy and/or function of the pulmonary system after a patient has undergone treatment. This
      study involves research using X-Ray computed tomography (CT) scanner, which is similar to
      previous CT scanners but operates much faster and provides finer image detail.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Normal lung aging assessed by CT imaging
time frame: up to 10 years
description: Normal aging process of the lungs compared to common smoking related lung diseases.
arm group label: Study Participants
arm group type: Experimental
description: Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.
intervention type: Diagnostic Test
intervention name: Pulmonary Function Test
description: Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes
arm group label: Study Participants
intervention type: Diagnostic Test
intervention name: CT Scans
description: volume scans, perfusion scan, ventilation scan
arm group label: Study Participants
intervention type: Behavioral
intervention name: Questionnaires
description: Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire
arm group label: Study Participants
intervention type: Diagnostic Test
intervention name: MRI
description: proton scans, hyperpolarized 3-Helium scan
arm group label: Study Participants
intervention type: Biological
intervention name: Xenon gas
description: ventilation CT scans
arm group label: Study Participants
criteria: 
gender: All
minimum age: 20 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric A Hoffman, PhD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Eric A. Hoffman
investigator title: Professor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Xenon
sharing ipd: Yes
ipd description: CT images will be shared including non-contrast images at TLC, FRC and RV as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be made available starting 6 months after publication of the primary results of each aim
ipd access criteria: Data will be provided to academic-based researchers upon written request to the PI, Eric A. Hoffman, PhD. A nominal charge will be made for the time it takes for a technician to prepare and transfer the requested data. This costs will not exceed $250. This service will be available for a minimum of 2 years of study close.