<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/NCT02978170</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0466</org_study_id>
    <secondary_id>NCI-2017-00628</secondary_id>
    <secondary_id>2016-0466</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT02978170</nct_id>
  </id_info>
  <brief_title>CBCT in Guiding Bronchoscopy in Patients With Lung Lesions</brief_title>
  <official_title>A New Guide for Our Guided-Bronchoscopy: The Use of Cone-Beam CT to Enhance Navigation and Diagnostic Yield of RP-EBUS and Hybrid Bronchoscope for Peripheral Lung Nodules Suspicious for Malignancy: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
      This pilot clinical trial studies how well cone-beam computed tomography (CBCT) works in&#xD;
      guiding bronchoscopy in patients with lung lesions. CBCT during bronchoscopy may help doctors&#xD;
      to biopsy lung lesions that are harder to reach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To describe the feasibility of using CBCT as an additional aid to guided-bronchoscopy with&#xD;
      radial probe endobronchial ultrasound (RP-EBUS)/hybrid scope for the diagnosis of peripheral&#xD;
      lung nodules.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in&#xD;
      whom the lesion is identified by RP-EBUS (RP-EBUS-navigation yield) and confirmed with CBCT.&#xD;
&#xD;
      II. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in&#xD;
      whom the lesion is identified by RP-EBUS and samples are diagnostic (diagnostic&#xD;
      yield-RP-EBUS).&#xD;
&#xD;
      III. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in&#xD;
      whom the lesion is identified by RP-EBUS, samples were non-diagnostic, and CBCT prompted&#xD;
      further tool re-location (i.e. change of needle angle, change of tool) leading to diagnosis.&#xD;
&#xD;
      IV. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in&#xD;
      whom the lesion is not identified by RP-EBUS, and CBCT-aided navigation allowed the operator&#xD;
      to reach the lesion (CBCT-added navigation yield).&#xD;
&#xD;
      V. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in&#xD;
      whom the lesion is not identified by RP-EBUS and CBCT-aided navigation allowed the operator&#xD;
      to reach the lesion and obtain a diagnosis (CBCT-added diagnostic yield).&#xD;
&#xD;
      VI. Describe the relationship between RP-PROBE and target (contact/no contact;&#xD;
      central/peripheral).&#xD;
&#xD;
      VII. Describe the relationship between needle tip and target (contact/no contact;&#xD;
      central/peripheral).&#xD;
&#xD;
      VIII. Describe the influence of points 6 and 7 on diagnostic yield. IX. Describe fluoroscopy&#xD;
      time. X. Describe estimated amount of radiation generated by CBCT use. XI. Describe&#xD;
      bronchoscopy time (first scope in/last scope out). XII. Describe the proportion of patients&#xD;
      in whom molecular analysis for lung cancer (i.e. EGFR, K-RAS, ALK) can be performed.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo CBCT during standard of care bronchoscopy.&#xD;
&#xD;
      After completion of study, patients with lesions found not to be cancerous are followed up&#xD;
      for 6 months to watch for changes (standard care).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2016</start_date>
  <completion_date type="Actual">May 4, 2019</completion_date>
  <primary_completion_date type="Actual">May 4, 2019</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>Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will be considered feasible if researchers can locate target and bronchoscopic tools with cone-beam computed tomography in at least 80% of the patients (16 out of the 20 participants) that are enrolled.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with peripheral nodules undergoing bronchoscopy in different subsample</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will conduct extensive descriptive analyses of the data collected. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Localization of the tip with respect to targets</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will assess the relationship between radial probe/needle tip and target. Will conduct extensive descriptive analyses of the data collected. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will assess the influence of points 6 and 7 on diagnostic yield. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of radiation generated by cone-beam computed tomography use</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy/bronchoscopy time</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Pulmonary Mass</condition>
  <arm_group>
    <arm_group_label>Diagnostic (CBCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo CBCT during standard of care bronchoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cone-Beam Computed Tomography</intervention_name>
    <description>Undergo CBCT</description>
    <arm_group_label>Diagnostic (CBCT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing guided-bronchoscopy for diagnosis of peripheral lung lesion/s &gt; 1&#xD;
             and &lt; 3 cm in diameter located in the outer 2/3 of the lung fields&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patient with indications for mediastinal lymph node (LN) sampling per 13th American&#xD;
             College of Clinical Pharmacy (ACCP) guidelines&#xD;
&#xD;
          -  Patient with metastatic disease (from primaries other than lung) who have suspicious&#xD;
             mediastinal or hilar LN that require sampling&#xD;
&#xD;
          -  Patients with contraindication/s for general anesthesia (e.g., severe and active&#xD;
             coronary artery disease, chronic obstructive pulmonary disease [COPD] with forced&#xD;
             expiratory volume in 1 second [FEV1] &lt; 1 liter, uncontrolled hypertension, increased&#xD;
             intracranial pressure, history of intolerance to general anesthesia)&#xD;
&#xD;
          -  Dementia or other severe cognitive impairment causing inability to understand or&#xD;
             consent to the procedure and study&#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>Roberto Casal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>May 31, 2019</last_update_submitted>
  <last_update_submitted_qc>May 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02978170
org study id: 2016-0466
secondary id: NCI-2017-00628
secondary id: 2016-0466
secondary id: P30CA016672
nct id: NCT02978170
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot clinical trial studies how well cone-beam computed tomography (CBCT) works in
      guiding bronchoscopy in patients with lung lesions. CBCT during bronchoscopy may help doctors
      to biopsy lung lesions that are harder to reach.
PRIMARY OBJECTIVES:

      I. To describe the feasibility of using CBCT as an additional aid to guided-bronchoscopy with
      radial probe endobronchial ultrasound (RP-EBUS)/hybrid scope for the diagnosis of peripheral
      lung nodules.

      SECONDARY OBJECTIVES:

      I. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in
      whom the lesion is identified by RP-EBUS (RP-EBUS-navigation yield) and confirmed with CBCT.

      II. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in
      whom the lesion is identified by RP-EBUS and samples are diagnostic (diagnostic
      yield-RP-EBUS).

      III. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in
      whom the lesion is identified by RP-EBUS, samples were non-diagnostic, and CBCT prompted
      further tool re-location (i.e. change of needle angle, change of tool) leading to diagnosis.

      IV. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in
      whom the lesion is not identified by RP-EBUS, and CBCT-aided navigation allowed the operator
      to reach the lesion (CBCT-added navigation yield).

      V. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in
      whom the lesion is not identified by RP-EBUS and CBCT-aided navigation allowed the operator
      to reach the lesion and obtain a diagnosis (CBCT-added diagnostic yield).

      VI. Describe the relationship between RP-PROBE and target (contact/no contact;
      central/peripheral).

      VII. Describe the relationship between needle tip and target (contact/no contact;
      central/peripheral).

      VIII. Describe the influence of points 6 and 7 on diagnostic yield. IX. Describe fluoroscopy
      time. X. Describe estimated amount of radiation generated by CBCT use. XI. Describe
      bronchoscopy time (first scope in/last scope out). XII. Describe the proportion of patients
      in whom molecular analysis for lung cancer (i.e. EGFR, K-RAS, ALK) can be performed.

      OUTLINE:

      Patients undergo CBCT during standard of care bronchoscopy.

      After completion of study, patients with lesions found not to be cancerous are followed up
      for 6 months to watch for changes (standard care).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography
time frame: Up to 6 months
description: Will be considered feasible if researchers can locate target and bronchoscopic tools with cone-beam computed tomography in at least 80% of the patients (16 out of the 20 participants) that are enrolled.
measure: Proportion of patients with peripheral nodules undergoing bronchoscopy in different subsample
time frame: Up to 6 months
description: Will conduct extensive descriptive analyses of the data collected. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.
measure: Localization of the tip with respect to targets
time frame: Up to 6 months
description: Will assess the relationship between radial probe/needle tip and target. Will conduct extensive descriptive analyses of the data collected. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.
measure: Diagnostic yield
time frame: Up to 6 months
description: Will assess the influence of points 6 and 7 on diagnostic yield. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.
measure: Amount of radiation generated by cone-beam computed tomography use
time frame: Up to 6 months
description: Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.
measure: Fluoroscopy/bronchoscopy time
time frame: Up to 6 months
description: Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate.
arm group label: Diagnostic (CBCT)
arm group type: Experimental
description: Patients undergo CBCT during standard of care bronchoscopy.
intervention type: Procedure
intervention name: Cone-Beam Computed Tomography
description: Undergo CBCT
arm group label: Diagnostic (CBCT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberto Casal, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor