xml: <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/NCT06028646</url>
    </required_header>
    <id_info>
      <org_study_id>22-01279</org_study_id>
      <nct_id>NCT06028646</nct_id>
    </id_info>
    <brief_title>Dynamic Airway CT is Diagnostic for Tracheomalacia in Children</brief_title>
    <official_title>Dynamic Airway CT is Diagnostic for Tracheomalacia in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NYU Langone Health</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway&#xD;
        Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom&#xD;
        flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic&#xD;
        accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive&#xD;
        alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia.&#xD;
        The results from this pilot study will help to estimate sample size for a larger-scale study&#xD;
        with more precise estimates of DA-CT diagnostic potential.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">October 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 10, 2023</primary_completion_date>
    <phase>N/A</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of dynamic narrowing on Flexible Bronchoscopy</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Video recordings and images will be deidentified and reviewed by pediatric pulmonologists and scores averaged.&#xD;
  Severity of dynamic narrowing will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: &gt;90%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity of Maximal Airway Change (MAC) on DA-CT</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Severity of MAC will be classified as follows: mild: 33%-49%, moderate: 50%-66%, severe: &gt;67%.&#xD;
  This outcome will be measured using the following equation:&#xD;
  MAC = tracheal cross-sectional (CSA) at narrowed segment in inspiration/CSA of trachea at thoracic inlet in inspiration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity of Excessive dynamic airway collapse (EDAC) on DA-CT</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Severity of EDAC will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: &gt;90%.&#xD;
  This outcome will be measured using the following equation:&#xD;
  EDAC = CSA at airway segment in expiration/CSA at same location in inspiration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Contrast-to-noise-ratio (CNR) of DA-CT scanners</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>This outcome will be measured using the following equation:&#xD;
  CNR = (mean Hounsfield Units (HU) in the artery regions of interest (ROI) - mean HU in the tracheal air column ROI) / image noise inside the trachea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative Analysis of DA-CT image noise based on 5-point Likert scale</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radiation exposure of DA-CT scanners</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>The effective dose (in mSv) will be automatically calculated with tissue weighting factors</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Tracheomalacia</condition>
    <arm_group>
      <arm_group_label>Dynamic Airway CT scan (DA-CT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will have a DA-CT scan after flexible bronchoscopy has been performed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Dynamic Airway CT scan (DA-CT)</intervention_name>
      <description>Patient will be asked to perform movements during the scan.</description>
      <arm_group_label>Dynamic Airway CT scan (DA-CT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants 0-18 years old, with&#xD;
  &#xD;
            -  Clinically indicated flexible bronchoscopy has been performed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Unable to undergo CT scanning without sedation&#xD;
  &#xD;
            -  Patients with tracheostomy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eleanor Muise, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Soumia Hammouda</last_name>
      <phone>347-204-3293</phone>
      <email>Soumia.Hammouda@nyulangone.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fink Children's Ambulatory Center/Hassenfeld Children's Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Tisch Hospital</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Tracheomalacia in Children</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tracheomalacia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Eleanor.Muise@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
      <ipd_access_criteria>The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Eleanor.Muise@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028646
  org study id: 22-01279
  nct id: NCT06028646
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway
        Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom
        flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic
        accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive
        alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia.
        The results from this pilot study will help to estimate sample size for a larger-scale study
        with more precise estimates of DA-CT diagnostic potential.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Severity of dynamic narrowing on Flexible Bronchoscopy
  time frame: Through study completion, an average of 1 year
  description: Video recordings and images will be deidentified and reviewed by pediatric pulmonologists and scores averaged.
  Severity of dynamic narrowing will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: >90%.
  measure: Severity of Maximal Airway Change (MAC) on DA-CT
  time frame: Through study completion, an average of 1 year
  description: Severity of MAC will be classified as follows: mild: 33%-49%, moderate: 50%-66%, severe: >67%.
  This outcome will be measured using the following equation:
  MAC = tracheal cross-sectional (CSA) at narrowed segment in inspiration/CSA of trachea at thoracic inlet in inspiration
  measure: Severity of Excessive dynamic airway collapse (EDAC) on DA-CT
  time frame: Through study completion, an average of 1 year
  description: Severity of EDAC will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: >90%.
  This outcome will be measured using the following equation:
  EDAC = CSA at airway segment in expiration/CSA at same location in inspiration
  measure: Contrast-to-noise-ratio (CNR) of DA-CT scanners
  time frame: Through study completion, an average of 1 year
  description: This outcome will be measured using the following equation:
  CNR = (mean Hounsfield Units (HU) in the artery regions of interest (ROI) - mean HU in the tracheal air column ROI) / image noise inside the trachea.
  measure: Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale
  time frame: Through study completion, an average of 1 year
  description: 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
  measure: Qualitative Analysis of DA-CT image noise based on 5-point Likert scale
  time frame: Through study completion, an average of 1 year
  description: 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
  measure: Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale
  time frame: Through study completion, an average of 1 year
  description: 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
  measure: Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale
  time frame: Through study completion, an average of 1 year
  description: 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
  measure: Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale
  time frame: Through study completion, an average of 1 year
  description: 5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent
  measure: Radiation exposure of DA-CT scanners
  time frame: Through study completion, an average of 1 year
  description: The effective dose (in mSv) will be automatically calculated with tissue weighting factors
  arm group label: Dynamic Airway CT scan (DA-CT)
  arm group type: Experimental
  description: All participants will have a DA-CT scan after flexible bronchoscopy has been performed.
  intervention type: Device
  intervention name: Dynamic Airway CT scan (DA-CT)
  description: Patient will be asked to perform movements during the scan.
  arm group label: Dynamic Airway CT scan (DA-CT)
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Eleanor Muise, MD
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Soumia Hammouda
  phone: 347-204-3293
  email: Soumia.Hammouda@nyulangone.org
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Tracheomalacia
  sharing ipd: Yes
  ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Eleanor.Muise@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
  ipd access criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Eleanor.Muise@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.