<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/NCT02983903</url>
  </required_header>
  <id_info>
    <org_study_id>IRB # 825506</org_study_id>
    <nct_id>NCT02983903</nct_id>
  </id_info>
  <brief_title>Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions</brief_title>
  <official_title>An Un-blinded, Intra-patient Comparison of Transbronchial Forceps Biopsy and Cryobiopsy for Peripheral Pulmonary Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Andrew Haas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anil Vachani</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anthony Lanfranco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kevin Ma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jeffrey Thompson</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Edmund Moon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim is&#xD;
      to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in patients&#xD;
      at risk for lung cancer. Target population: Patients referred for bronchoscopy and lung&#xD;
      biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients&#xD;
      enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies&#xD;
      for their lung lesion during bronchoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim analysis also showed a lack of benefit in the experimental arm.&#xD;
  </why_stopped>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">March 2, 2020</completion_date>
  <primary_completion_date type="Actual">March 2, 2020</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>The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule.</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity for cancer is defined as true positives / (true positives + false negatives) with respect to diagnosing malignancy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of any further, more invasive testing that is clinically indicated to evaluate the nodule.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The increase in sensitivity for diagnosing a specific benign lung disease with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule.</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity is defined as true positives / (true positives + false negatives) with respect to diagnosing a specific benign condition that is thought to represent the lung nodule seen on CT scan. If the bronchoscopic procedure fails to diagnose a specific benign condition, the gold standard will be the results of any further, more invasive testing and stable follow-up imaging at 1 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of participants with pneumothorax or significant bleeding related to the addition of transbronchial cryobiopsy to standard forceps biopsy.</measure>
    <time_frame>1 year</time_frame>
    <description>A chest X-ray and ultrasound will be done to check for pneumothorax after standard forceps biopsy and after the addition of transbronchial cryobiopsy. Bleeding will be measured with a standardized scale (grade 0 = traces of blood not requiring suctioning; grade 1 = bleeding requiring suction to clear; grade 2 = bleeding requiring wedging of the biopsied segment with the flexible bronchoscope and/or iced saline/epinephrine; grade 3 = bleeding requiring further intervention such as balloon occlusion or inflation of the bronchial blocker; grade 4 = bleeding resulting in airway obstruction and acute hypoxemic respiratory failure, cardiopulmonary instability, transfusion of packed RBCs, and/or admission to the ICU) both after forceps biopsy and again after transbronchial cryobiopsy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Solitary Pulmonary Nodule</condition>
  <condition>Multiple Pulmonary Nodules</condition>
  <arm_group>
    <arm_group_label>Single intervention arm - transbronchial biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transbronchial biopsy</intervention_name>
    <arm_group_label>Single intervention arm - transbronchial biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;/= 18&#xD;
&#xD;
          2. At least one peripheral lung lesion &gt;8mm documented on CT scan referred for diagnostic&#xD;
             bronchoscopy&#xD;
&#xD;
          3. Subject is able to undergo informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Coagulopathy (platelet count &lt; 50,000, INR &gt; 1.5) detected on blood testing done&#xD;
             within 6 weeks of the procedural visit&#xD;
&#xD;
          2. Lesion associated with a prominent vessel evident on CT scan&#xD;
&#xD;
          3. Pure ground glass lesion&#xD;
&#xD;
          4. Fibrotic interstitial lung abnormalities on chest CT&#xD;
&#xD;
          5. Bullous emphysema in region of nodule&#xD;
&#xD;
          6. Supplemental oxygen utilization at baseline&#xD;
&#xD;
          7. BMI &gt; 40&#xD;
&#xD;
          8. End stage renal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David M DiBardino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennslyvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>David DiBardino</investigator_full_name>
    <investigator_title>Assistant Professor of Clinical Medicine, Section of Interventional Pulmonology and Thoracic Oncology, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Pulmonary Nodules</mesh_term>
    <mesh_term>Solitary Pulmonary Nodule</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/NCT02983903
org study id: IRB # 825506
nct id: NCT02983903
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim is
      to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in patients
      at risk for lung cancer. Target population: Patients referred for bronchoscopy and lung
      biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients
      enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies
      for their lung lesion during bronchoscopy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule.
time frame: 1 year
description: Sensitivity for cancer is defined as true positives / (true positives + false negatives) with respect to diagnosing malignancy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of any further, more invasive testing that is clinically indicated to evaluate the nodule.
measure: The increase in sensitivity for diagnosing a specific benign lung disease with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule.
time frame: 1 year
description: Sensitivity is defined as true positives / (true positives + false negatives) with respect to diagnosing a specific benign condition that is thought to represent the lung nodule seen on CT scan. If the bronchoscopic procedure fails to diagnose a specific benign condition, the gold standard will be the results of any further, more invasive testing and stable follow-up imaging at 1 year.
measure: The number of participants with pneumothorax or significant bleeding related to the addition of transbronchial cryobiopsy to standard forceps biopsy.
time frame: 1 year
description: A chest X-ray and ultrasound will be done to check for pneumothorax after standard forceps biopsy and after the addition of transbronchial cryobiopsy. Bleeding will be measured with a standardized scale (grade 0 = traces of blood not requiring suctioning; grade 1 = bleeding requiring suction to clear; grade 2 = bleeding requiring wedging of the biopsied segment with the flexible bronchoscope and/or iced saline/epinephrine; grade 3 = bleeding requiring further intervention such as balloon occlusion or inflation of the bronchial blocker; grade 4 = bleeding resulting in airway obstruction and acute hypoxemic respiratory failure, cardiopulmonary instability, transfusion of packed RBCs, and/or admission to the ICU) both after forceps biopsy and again after transbronchial cryobiopsy.
arm group label: Single intervention arm - transbronchial biopsy
arm group type: Experimental
description: Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy
intervention type: Procedure
intervention name: transbronchial biopsy
arm group label: Single intervention arm - transbronchial biopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David M DiBardino, MD
role: Principal Investigator
affiliation: University of Pennslyvania
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: David DiBardino
investigator title: Assistant Professor of Clinical Medicine, Section of Interventional Pulmonology and Thoracic Oncology, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania
mesh term: Multiple Pulmonary Nodules
mesh term: Solitary Pulmonary Nodule
sharing ipd: No