<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/NCT02259452</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC0808</org_study_id>
    <nct_id>NCT02259452</nct_id>
  </id_info>
  <brief_title>Radiation Induced Cardiopulmonary Injury in Humans</brief_title>
  <official_title>Radiation Induced Cardiopulmonary Injury in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the time, dose dependence, and fraction-size dependence&#xD;
      of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure&#xD;
      following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI&#xD;
      hopes to develop models to better relate and predict RT-induced changes in regional lung and&#xD;
      heart perfusion/function/structure with changes in global cardiopulmonary function. Patients&#xD;
      will undergo pre- and serial post-RT lung and heart assessments to better understand&#xD;
      RT-induced regional heart/lung changes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Decision to not gather further data&#xD;
  </why_stopped>
  <start_date>June 2008</start_date>
  <primary_completion_date type="Actual">April 13, 2018</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>Changes in Regional Lung Function</measure>
    <time_frame>Up to 4 years post CRT</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Regional Heart Function</measure>
    <time_frame>Up to 4 years post CRT</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes</measure>
    <time_frame>Up to 4 years post CRT</time_frame>
  </primary_outcome>
  <enrollment type="Actual">91</enrollment>
  <condition>Thoracic</condition>
  <condition>Pulmonary Injury</condition>
  <condition>Heart Injuries</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SPECT Lung Perfusion Scan</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SPECT Heart Perfusion Scan</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary Function Tests</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are to receive 3D-planned RT for lung cancer (conformal or IMRT) or other&#xD;
        tumors in/around the thorax.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Patients who are to receive 3D-planned RT for tumor within and around the thorax.&#xD;
&#xD;
          3. Patients receiving incidental RT to portions of the heart are eligible.&#xD;
&#xD;
          4. Estimated minimum expected life expectancy of one year&#xD;
&#xD;
          5. Able to undergo the required study-related tests for regional lung injury and regional&#xD;
             heart injury&#xD;
&#xD;
          6. Patients of child bearing potential age must have a negative pregnancy test and must&#xD;
             agree to use appropriate birth control measures while in the study.&#xD;
&#xD;
          7. Patients must be able to give informed consent. Informed consent will be obtained&#xD;
             prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are anticipated to have thoracic surgery post-RT are ineligible.&#xD;
&#xD;
          2. Patients with large mediastinal/hilar tumors compressing the airways/vessels, and&#xD;
             negatively impacting on cardiovascular function&#xD;
&#xD;
          3. Pregnant or nursing women.&#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>Kyle Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina at Chapel Hill, Department of Radiation Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill, Department of Radiation Oncology</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiation Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Heart Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02259452
org study id: LCCC0808
nct id: NCT02259452
lead sponsor: 
has dmc: Yes
The purpose of the study is to assess the time, dose dependence, and fraction-size dependence
      of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure
      following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI
      hopes to develop models to better relate and predict RT-induced changes in regional lung and
      heart perfusion/function/structure with changes in global cardiopulmonary function. Patients
      will undergo pre- and serial post-RT lung and heart assessments to better understand
      RT-induced regional heart/lung changes.
observational model: Cohort
time perspective: Prospective
measure: Changes in Regional Lung Function
time frame: Up to 4 years post CRT
measure: Changes in Regional Heart Function
time frame: Up to 4 years post CRT
measure: Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes
time frame: Up to 4 years post CRT
intervention type: Procedure
intervention name: SPECT Lung Perfusion Scan
intervention type: Procedure
intervention name: SPECT Heart Perfusion Scan
intervention type: Procedure
intervention name: Pulmonary Function Tests
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyle Wang, MD
role: Principal Investigator
affiliation: University of North Carolina at Chapel Hill, Department of Radiation Oncology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Injury
mesh term: Wounds and Injuries
mesh term: Heart Injuries