<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/NCT03256773</url>
  </required_header>
  <id_info>
    <org_study_id>F160125001</org_study_id>
    <nct_id>NCT03256773</nct_id>
  </id_info>
  <brief_title>High Resolution Micro OCT Imaging</brief_title>
  <official_title>Imaging of Human Epithelial Airway Using a High Resolution Micro OCT Catheter (Functional Anatomic Imaging of CF Patients With Early Lung Disease Using Micro OCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn about using the imaging to make images of the lungs and&#xD;
      nose with the long-term goal of the research leading to potential treatments and new&#xD;
      therapies for patients with cystic fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung Disease is the predominate cause of morbidity and mortality in patients with cystic&#xD;
      fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order&#xD;
      to reveal the features that may lead to the onset of progressive lung disease. Discerning the&#xD;
      nature of the CF defect could resolve longstanding controversy and result in a new&#xD;
      therapeutic opportunity that may address pathophysiology. Recently the investigators have&#xD;
      developed an innovative technology, termed 1-µm resolution optical coherence tomography&#xD;
      (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial&#xD;
      surface of living airways.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 15, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>feasibility of uOCT probe</measure>
    <time_frame>1 year</time_frame>
    <description>to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cystic Fibrosis</condition>
  <condition>COPD</condition>
  <condition>PCD - Primary Ciliary Dyskinesia</condition>
  <condition>Covid19</condition>
  <condition>Sinusitis</condition>
  <arm_group>
    <arm_group_label>Notmal</arm_group_label>
    <description>No lung Disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cystic Fibrosis</arm_group_label>
    <description>cystic fibrosis Lung Disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCD</arm_group_label>
    <description>Primary Ciliary Dyskinesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <description>Chronic Obstructive Lung Disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with CF, COPD, Sinusitis, PCD and COVID 19 will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        THE INCLUSION CRITERIA:&#xD;
&#xD;
          -  Patients diagnosed with CF or healthy normal controls with no respiratory disease&#xD;
&#xD;
          -  Patients must be over the age of 14&#xD;
&#xD;
          -  Patient must be able to give informed consent&#xD;
&#xD;
        THE EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Patients with recent respiratory infection requiring antibiotics or corticosteroids in&#xD;
             the last 4 weeks (excluding routine perioperative antibiotics)&#xD;
&#xD;
          -  Patients with major sinus surgery that will alter the nasal anatomy and preclude&#xD;
             imaging of the nares&#xD;
&#xD;
          -  Any condition that in the opinion of the investigator will alter the safety of pilot&#xD;
             testing in the operating room&#xD;
&#xD;
          -  Female subjects who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven M Rowe</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heather Hathorne, PhD</last_name>
    <phone>205-638-9568</phone>
    <email>hhathorne@peds.uab.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ginger Reeves, BS</last_name>
    <phone>205-638-5970</phone>
    <email>greeves@peds.uab.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Hathorne, PhD</last_name>
      <phone>205-638-9568</phone>
      <email>hhathorne@peds.uab.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ginger Reeves, BS</last_name>
      <phone>205-638-5970</phone>
      <email>greeves@peds.uab.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Rowe Steven, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Steven M Rowe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Ciliary Motility Disorders</mesh_term>
    <mesh_term>Dyskinesias</mesh_term>
  </condition_browse>
  <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/NCT03256773
org study id: F160125001
nct id: NCT03256773
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn about using the imaging to make images of the lungs and
      nose with the long-term goal of the research leading to potential treatments and new
      therapies for patients with cystic fibrosis.
Lung Disease is the predominate cause of morbidity and mortality in patients with cystic
      fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order
      to reveal the features that may lead to the onset of progressive lung disease. Discerning the
      nature of the CF defect could resolve longstanding controversy and result in a new
      therapeutic opportunity that may address pathophysiology. Recently the investigators have
      developed an innovative technology, termed 1-µm resolution optical coherence tomography
      (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial
      surface of living airways.
observational model: Cohort
time perspective: Prospective
measure: feasibility of uOCT probe
time frame: 1 year
description: to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients
arm group label: Notmal
description: No lung Disease
arm group label: Cystic Fibrosis
description: cystic fibrosis Lung Disease
arm group label: PCD
description: Primary Ciliary Dyskinesia
arm group label: COPD
description: Chronic Obstructive Lung Disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Steven M Rowe
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Heather Hathorne, PhD
phone: 205-638-9568
email: hhathorne@peds.uab.edu
last name: Ginger Reeves, BS
phone: 205-638-5970
email: greeves@peds.uab.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Steven M Rowe
investigator title: Principal Investigator
mesh term: Sinusitis
mesh term: Cystic Fibrosis
mesh term: Ciliary Motility Disorders
mesh term: Dyskinesias
sharing ipd: No