<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/NCT02978885</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR0395</org_study_id>
    <secondary_id>1R01HL131960-01</secondary_id>
    <nct_id>NCT02978885</nct_id>
  </id_info>
  <brief_title>Imaging of Peri-operative (periOP) Lung Injury</brief_title>
  <official_title>In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission&#xD;
      computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury.&#xD;
      The investigators will study patients undergoing major surgery, specifically Whipple&#xD;
      procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and&#xD;
      after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung injury is commonly not detected unless structural damage has occurred. SPECT-CT scanning&#xD;
      using a specific tracer that lights up when it detects apoptosis (programmed cell death) has&#xD;
      been used to detect even minor lung injury for example by smoke inhalation in animals and may&#xD;
      be more sensitive to detect a less severe injury. The present study aims to study SPECT-CT&#xD;
      scan using a tracer for apoptosis, 99mTc Annexin V-128 (AxV- 128/Tc), to detect lung injury&#xD;
      after major surgery. Prolonged ventilation during surgery can cause minor lung injury but is&#xD;
      usually not clinically detected. The investigators are planning to study 40 patients (20&#xD;
      patients with pre-existing lung disease-COPD and 20 patients with normal preoperative lung&#xD;
      function) who are undergoing Whipple operations or other major surgery. The investigators&#xD;
      will obtain SPECT-CT scans before and then 2-3 days after surgery and compare the uptake of a&#xD;
      radioactive tracer with plasma markers of lung injury (Soluble Receptors for Advanced&#xD;
      Glycation End Products (sRAGE), Interleukin 6 (IL-6), Clara-cell 16 and lung surfactant&#xD;
      protein D (SP-D) among others). The investigators will ask the subjects to undergo spirometry&#xD;
      testing, blood draws and urine collection. In addition, a SPECT-CT scan that lasts&#xD;
      approximately 1 hour will be performed prior to surgery and 2-3 days post-operatively (while&#xD;
      still hospitalized).&#xD;
&#xD;
      The total effective dose from the combined SPECT and CT scans is 6.2 millisievert (mSv). This&#xD;
      effective dose is below what a patient receives during a standard 2 dose rest and stress&#xD;
      cardiac nuclear imaging study and well within the range of current clinical nuclear imaging&#xD;
      tests. The exact long term risk for development of cancer from diagnostic radiological&#xD;
      procedures is currently under debate but all imaging procedures in this study are aimed to&#xD;
      keep total radiation burden As Low As Reasonably Achievable (ALARA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">June 11, 2018</start_date>
  <completion_date type="Actual">February 5, 2020</completion_date>
  <primary_completion_date type="Actual">February 5, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of AxV-128/Tc Uptake and Fibrinogen</measure>
    <time_frame>Up to 1 week from initial scan</time_frame>
    <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)</measure>
    <time_frame>Up to 1 week from initial scan</time_frame>
    <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count</measure>
    <time_frame>Up to 1 week from initial scan</time_frame>
    <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AxV-128/Tc Uptake</measure>
    <time_frame>Up to 1 week from initial scan</time_frame>
    <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of AxV-128/Tc Uptake and RAGE</measure>
    <time_frame>Up to 1 week from initial scan</time_frame>
    <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of AxV-128/Tc Uptake and IL-6</measure>
    <time_frame>Up to 1 week from initial scan</time_frame>
    <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of AxV-128/Tc Uptake and Clara-cell 16</measure>
    <time_frame>Up to 1 week from initial scan</time_frame>
    <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of AxV-128/Tc Uptake and SP-D</measure>
    <time_frame>Up to 1 week from initial scan</time_frame>
    <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Acute Lung Injury</condition>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Normal preoperative lung function</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preoperative COPD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SPECT-CT imaging</intervention_name>
    <description>Injection of AxV-128 labeled with 99mTc followed by SPECT CT</description>
    <arm_group_label>Normal preoperative lung function</arm_group_label>
    <arm_group_label>Preoperative COPD</arm_group_label>
    <other_name>SPECT CT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AxV-128/Tc</intervention_name>
    <description>Injection of AxV-128 labeled with 99mTc</description>
    <arm_group_label>Normal preoperative lung function</arm_group_label>
    <arm_group_label>Preoperative COPD</arm_group_label>
    <other_name>99mTc-rhAnnexin V-128</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Whipple procedure</intervention_name>
    <description>A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.</description>
    <arm_group_label>Normal preoperative lung function</arm_group_label>
    <arm_group_label>Preoperative COPD</arm_group_label>
    <other_name>Pancreaticoduodenectomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Major surgery</intervention_name>
    <description>Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
    <arm_group_label>Normal preoperative lung function</arm_group_label>
    <arm_group_label>Preoperative COPD</arm_group_label>
    <other_name>Surgical procedure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with moderate COPD (Global Initiative for Chronic Obstructive Lung Disease&#xD;
             (GOLD) stage II: forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) &lt;0.70&#xD;
             and FEV1 50-79% normal) undergoing Whipple procedures or other major surgeries&#xD;
&#xD;
          -  Patients with normal lung function undergoing Whipple procedures or other major&#xD;
             abdominal surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#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>Gebhard Wagener, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>August 17, 2021</results_first_submitted>
  <results_first_submitted_qc>August 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2021</results_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute lung injury</keyword>
  <keyword>Chronic obstructive pulmonary disease (COPD)</keyword>
  <keyword>Whipple procedures</keyword>
  <keyword>pancreatico-duodenectomies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT02978885/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Normal Preoperative Lung Function</title>
          <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
        </group>
        <group group_id="P2">
          <title>Preoperative COPD</title>
          <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Study terminated due to poor enrollment.</population>
      <group_list>
        <group group_id="B1">
          <title>Normal Preoperative Lung Function</title>
          <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
        </group>
        <group group_id="B2">
          <title>Preoperative COPD</title>
          <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Correlation of AxV-128/Tc Uptake and Fibrinogen</title>
        <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
        <time_frame>Up to 1 week from initial scan</time_frame>
        <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Preoperative Lung Function</title>
            <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Preoperative COPD</title>
            <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of AxV-128/Tc Uptake and Fibrinogen</title>
          <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
          <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)</title>
        <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
        <time_frame>Up to 1 week from initial scan</time_frame>
        <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Preoperative Lung Function</title>
            <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Preoperative COPD</title>
            <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)</title>
          <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
          <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count</title>
        <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
        <time_frame>Up to 1 week from initial scan</time_frame>
        <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Preoperative Lung Function</title>
            <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Preoperative COPD</title>
            <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count</title>
          <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
          <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AxV-128/Tc Uptake</title>
        <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
        <time_frame>Up to 1 week from initial scan</time_frame>
        <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Preoperative Lung Function</title>
            <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Preoperative COPD</title>
            <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>AxV-128/Tc Uptake</title>
          <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
          <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation of AxV-128/Tc Uptake and RAGE</title>
        <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
        <time_frame>Up to 1 week from initial scan</time_frame>
        <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Preoperative Lung Function</title>
            <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Preoperative COPD</title>
            <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of AxV-128/Tc Uptake and RAGE</title>
          <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
          <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation of AxV-128/Tc Uptake and IL-6</title>
        <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
        <time_frame>Up to 1 week from initial scan</time_frame>
        <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Preoperative Lung Function</title>
            <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Preoperative COPD</title>
            <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of AxV-128/Tc Uptake and IL-6</title>
          <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
          <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation of AxV-128/Tc Uptake and Clara-cell 16</title>
        <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
        <time_frame>Up to 1 week from initial scan</time_frame>
        <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Preoperative Lung Function</title>
            <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Preoperative COPD</title>
            <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of AxV-128/Tc Uptake and Clara-cell 16</title>
          <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
          <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation of AxV-128/Tc Uptake and SP-D</title>
        <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
        <time_frame>Up to 1 week from initial scan</time_frame>
        <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Preoperative Lung Function</title>
            <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Preoperative COPD</title>
            <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of AxV-128/Tc Uptake and SP-D</title>
          <description>To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD</description>
          <population>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 1 week from initial scan</time_frame>
      <desc>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</desc>
      <group_list>
        <group group_id="E1">
          <title>Normal Preoperative Lung Function</title>
          <description>Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
        </group>
        <group group_id="E2">
          <title>Preoperative COPD</title>
          <description>Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).&#xD;
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT&#xD;
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc&#xD;
Whipple procedure: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.&#xD;
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.&#xD;
Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Gebhard Wagener, MD</name_or_title>
      <organization>Columbia University</organization>
      <phone>212-305-6494</phone>
      <email>gw72@cumc.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02978885
org study id: AAAR0395
secondary id: 1R01HL131960-01
nct id: NCT02978885
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission
      computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury.
      The investigators will study patients undergoing major surgery, specifically Whipple
      procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and
      after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.
Lung injury is commonly not detected unless structural damage has occurred. SPECT-CT scanning
      using a specific tracer that lights up when it detects apoptosis (programmed cell death) has
      been used to detect even minor lung injury for example by smoke inhalation in animals and may
      be more sensitive to detect a less severe injury. The present study aims to study SPECT-CT
      scan using a tracer for apoptosis, 99mTc Annexin V-128 (AxV- 128/Tc), to detect lung injury
      after major surgery. Prolonged ventilation during surgery can cause minor lung injury but is
      usually not clinically detected. The investigators are planning to study 40 patients (20
      patients with pre-existing lung disease-COPD and 20 patients with normal preoperative lung
      function) who are undergoing Whipple operations or other major surgery. The investigators
      will obtain SPECT-CT scans before and then 2-3 days after surgery and compare the uptake of a
      radioactive tracer with plasma markers of lung injury (Soluble Receptors for Advanced
      Glycation End Products (sRAGE), Interleukin 6 (IL-6), Clara-cell 16 and lung surfactant
      protein D (SP-D) among others). The investigators will ask the subjects to undergo spirometry
      testing, blood draws and urine collection. In addition, a SPECT-CT scan that lasts
      approximately 1 hour will be performed prior to surgery and 2-3 days post-operatively (while
      still hospitalized).

      The total effective dose from the combined SPECT and CT scans is 6.2 millisievert (mSv). This
      effective dose is below what a patient receives during a standard 2 dose rest and stress
      cardiac nuclear imaging study and well within the range of current clinical nuclear imaging
      tests. The exact long term risk for development of cancer from diagnostic radiological
      procedures is currently under debate but all imaging procedures in this study are aimed to
      keep total radiation burden As Low As Reasonably Achievable (ALARA).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation of AxV-128/Tc Uptake and Fibrinogen
time frame: Up to 1 week from initial scan
description: To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
measure: Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)
time frame: Up to 1 week from initial scan
description: To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
measure: Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count
time frame: Up to 1 week from initial scan
description: To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
measure: AxV-128/Tc Uptake
time frame: Up to 1 week from initial scan
description: To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
measure: Correlation of AxV-128/Tc Uptake and RAGE
time frame: Up to 1 week from initial scan
description: To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
measure: Correlation of AxV-128/Tc Uptake and IL-6
time frame: Up to 1 week from initial scan
description: To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
measure: Correlation of AxV-128/Tc Uptake and Clara-cell 16
time frame: Up to 1 week from initial scan
description: To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
measure: Correlation of AxV-128/Tc Uptake and SP-D
time frame: Up to 1 week from initial scan
description: To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
arm group label: Normal preoperative lung function
arm group type: Other
description: Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).
arm group label: Preoperative COPD
arm group type: Other
description: Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).
intervention type: Radiation
intervention name: SPECT-CT imaging
description: Injection of AxV-128 labeled with 99mTc followed by SPECT CT
arm group label: Normal preoperative lung function
arm group label: Preoperative COPD
other name: SPECT CT
intervention type: Drug
intervention name: AxV-128/Tc
description: Injection of AxV-128 labeled with 99mTc
arm group label: Normal preoperative lung function
arm group label: Preoperative COPD
other name: 99mTc-rhAnnexin V-128
intervention type: Procedure
intervention name: Whipple procedure
description: A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.
arm group label: Normal preoperative lung function
arm group label: Preoperative COPD
other name: Pancreaticoduodenectomy
intervention type: Procedure
intervention name: Major surgery
description: Additional surgical procedure(s) that is clinically indicated. Standard of care.
arm group label: Normal preoperative lung function
arm group label: Preoperative COPD
other name: Surgical procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gebhard Wagener, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Lung Injury
mesh term: Acute Lung Injury
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
point of contact: 