<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/NCT03231397</url>
  </required_header>
  <id_info>
    <org_study_id>201702141</org_study_id>
    <nct_id>NCT03231397</nct_id>
  </id_info>
  <brief_title>Predictors of AAA Expansion and/or Rupture</brief_title>
  <official_title>Noninvasive Assessment of Abdominal Aortic Aneurysm (AAA) Wall Structural Integrity and Inflammation as Predictors of Expansion and/or Rupture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or&#xD;
      because they do not have an AAA (control group).&#xD;
&#xD;
      The purpose of this research study is to further study, through FEA, changes that occur in&#xD;
      the mechanical properties of the aortic wall. The investigator will compare two radiotracers,&#xD;
      18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about&#xD;
      inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging&#xD;
      during the PET-CT scan. The investigator will also compare the results describing the&#xD;
      mechanical properties of the AAA wall to the degree of inflammation in that wall as&#xD;
      determined by PET-CT imaging to define new and better predictors of AAA growth and/or&#xD;
      rupture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or&#xD;
      because they do not have an AAA (control group).&#xD;
&#xD;
      The aorta serves as the main artery to supply blood flow to the body. It is approximately the&#xD;
      size of a garden hose. Due to the effects of high blood pressure (hypertension),&#xD;
      atherosclerosis (hardening of the arteries), and tobacco use, the aorta may widen and enlarge&#xD;
      to form an aneurysm. An abdominal aortic aneurysm (AAA) is a dilation (enlargement) or&#xD;
      ballooning out of a section of blood vessel caused by disease or weakness in the wall of the&#xD;
      aorta below the level of the kidney arteries. As an AAA dilates and increases in size,&#xD;
      rupture of the AAA may occur. AAA rupture carries a significant risk of death.&#xD;
&#xD;
      Currently, aortic size is the primary factor used to assess aortic rupture risk. There are&#xD;
      other imaging procedures (imaging modalities) that are being used and developed to assess AAA&#xD;
      rupture risk. Finite element analysis (FEA) is a way to study the mechanical properties of&#xD;
      the aortic wall, including areas of stress and strength that are used to calculate rupture&#xD;
      risk. Positron Emission Tomography (PET) utilizes glucose (a form of sugar) labeled with a&#xD;
      radioactivity to look at the metabolic activity and inflammation in the aortic wall.&#xD;
&#xD;
      The purpose of this research study is to further study, through FEA, changes that occur in&#xD;
      the mechanical properties of the aortic wall. The investigator will compare two radiotracers,&#xD;
      18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about&#xD;
      inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging&#xD;
      during the PET-CT scan. The investigator will also compare the results describing the&#xD;
      mechanical properties of the AAA wall to the degree of inflammation in that wall as&#xD;
      determined by PET-CT imaging to define new and better predictors of AAA growth and/or&#xD;
      rupture.&#xD;
&#xD;
      The radioactive tracers that are used in this study are 18F-fludeoxyglucose (FDG) and&#xD;
      11C-PBR28 (PBR) which stands for Peripheral Benzodiazepine Receptor. 11C-PBR28 is considered&#xD;
      investigational, which means that it has not been approved by the U.S. Food and Drug&#xD;
      Administration. FDG is an approved drug by the FDA, however in this study it is considered&#xD;
      investigational.&#xD;
&#xD;
      Goal: Twenty-four subjects will be recruited for this study. Six control subjects (three&#xD;
      males and three females), will be considered. Control subjects will have known&#xD;
      atherosclerosis, without aneurysmal disease. Six subjects (three males and three females)&#xD;
      with small AAAs (diameter 3.0-4.5cm), six subjects (three males, AAA &gt;5.5cm and three&#xD;
      females, AAA &gt;5.0cm) with AAAs that are indicated for treatment, and six subjects (three&#xD;
      males and three females) with rapidly expanding AAAs (&gt;0.5cm over 6 months and/or &gt;1.0cm over&#xD;
      12 months) will be considered.&#xD;
&#xD;
      Subjects will have blood drawn to perform a genetic test that will look at genes and proteins&#xD;
      to determine subject eligibility. Once the blood work is assessed for eligibility, subjects&#xD;
      will undergo the PET-CT scan. The imaging will take approximately 3 hours to complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    We were unable to recruit more subjects who met the inclusion/exclusion criteria and we have&#xD;
    closed the study.&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or because they do not have an AAA (control group).&#xD;
The purpose of this research study is to further study, through FEA, changes that occur in the mechanical properties of the aortic wall. The investigator will compare two radiotracers, 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan. The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth and/or rupture.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Standard Uptake Value (SUV)</measure>
    <time_frame>1 day</time_frame>
    <description>Aortic inflammation as demonstrated by uptake of radiotracer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rupture Potential Index (RPI)</measure>
    <time_frame>9-10 months</time_frame>
    <description>Rupture potential index (RPI) is defined as the ratio of the acting wall stress to the wall strength, and the maximum RPI for AAA represents its rupture risk. Currently, the primary factor considered for risk of human AAA rupture is aortic diameter; however, it is well documented that small AAAs (&lt;5cm) rupture, while many large AAAs (&gt;8cm) are incidentally discovered.&#xD;
We will assess the ability of imaging techniques to determine abdominal aortic aneurysm (AAA) rupture risk individually and in concert.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative Comparison of SUV and RPI</measure>
    <time_frame>9-10 months</time_frame>
    <description>Finite element analysis (FEA) is a computerized numerical method used for the prediction of how the aorta may behave under stress. This software will be used to assess the same aortic volume comparing areas of greatest stress and lowest strength. Co-registration of images obtained by different imaging modalities will allow for comparison between imaging modalities. With direct co-registration of the data sets for each subject, qualitative comparisons will be made regarding areas of 18F-FDG and 11C-PBR28 uptake, as well as stress, strength, and RPI.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Abdominal Aortic Aneurysm (AAA)</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Small AAA's</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rapidly expanding AAA's</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Six subjects (three males and three females) with rapidly expanding AAAs (&gt;0.5cm over 6 months and/or &gt;1.0cm over 12 months).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AAA's undergoing treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Six subjects (three males, AAA &gt;5.5cm and three females, AAA &gt;5.0cm) with AAAs that are indicated for treatment.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Assess AAA rupture risk by PET-CTA scans</intervention_name>
    <description>Assess AAA rupture risk by PET-CTA scans</description>
    <arm_group_label>AAA's undergoing treatment</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Rapidly expanding AAA's</arm_group_label>
    <arm_group_label>Small AAA's</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-fludeoxyglucose (FDG)</intervention_name>
    <description>Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
    <arm_group_label>AAA's undergoing treatment</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Rapidly expanding AAA's</arm_group_label>
    <arm_group_label>Small AAA's</arm_group_label>
    <other_name>18F-FDG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>11C-PBR28</intervention_name>
    <description>Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
    <arm_group_label>AAA's undergoing treatment</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Rapidly expanding AAA's</arm_group_label>
    <arm_group_label>Small AAA's</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion&#xD;
&#xD;
          -  All ethnic groups&#xD;
&#xD;
          -  45 years of age or older&#xD;
&#xD;
          -  *Must fit into one of the three following groups:&#xD;
&#xD;
               -  Control group (atherosclerosis without aneurysmal disease&#xD;
&#xD;
               -  Small AAA (3-4.5 cm)&#xD;
&#xD;
               -  Rapidly growing AAA (0.5 cm in 6 months or 1 cm in 12 months)&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  At risk population (cognitively impaired)&#xD;
&#xD;
          -  Any exclusion for PT-CT (i.e., allergy to contrast)&#xD;
&#xD;
          -  Any woman planning to become pregnant, suspects pregnancy, pregnant or breastfeeding)&#xD;
&#xD;
          -  Any greater than normal potential for cardiac arrest&#xD;
&#xD;
          -  Renal disease (eGFR &lt;60 mg/ml/1.73m2)&#xD;
&#xD;
          -  Claustrophobic reactions and/or is unable to lie on the exam table for 60 minutes&#xD;
&#xD;
          -  Significant radiation exposure via other trials or medical testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sean J. English, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine, St. Louis, MO 63110</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <results_first_submitted>April 23, 2021</results_first_submitted>
  <results_first_submitted_qc>June 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 9, 2021</results_first_posted>
  <last_update_submitted>June 17, 2021</last_update_submitted>
  <last_update_submitted_qc>June 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Abdominal Aortic Aneurysm (AAA)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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>October 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03231397/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03231397/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The plan was to enroll 30 subjects, however, due to the lack of willing participants, we were only able to enroll 2 subjects.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="P2">
          <title>Small AAA's</title>
          <description>Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="P3">
          <title>Rapidly Expanding AAA's</title>
          <description>Six subjects (three males and three females) with rapidly expanding AAAs (&gt;0.5cm over 6 months and/or &gt;1.0cm over 12 months).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="P4">
          <title>AAA's Undergoing Treatment</title>
          <description>Six subjects (three males, AAA &gt;5.5cm and three females, AAA &gt;5.0cm) with AAAs that are indicated for treatment.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</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 group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>We were unable to enroll subjects in the control group and the AAA's undergoing treatment who met the inclusion/exclusion criteria.</population>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="B2">
          <title>Small AAA's</title>
          <description>Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="B3">
          <title>Rapidly Expanding AAA's</title>
          <description>Six subjects (three males and three females) with rapidly expanding AAAs (&gt;0.5cm over 6 months and/or &gt;1.0cm over 12 months).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="B4">
          <title>AAA's Undergoing Treatment</title>
          <description>Six subjects (three males, AAA &gt;5.5cm and three females, AAA &gt;5.0cm) with AAAs that are indicated for treatment.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="B5">
          <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="1"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="0"/>
            <count group_id="B5" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Standard Uptake Value (SUV)</title>
        <description>Aortic inflammation as demonstrated by uptake of radiotracer</description>
        <time_frame>1 day</time_frame>
        <population>Recruitment was difficult. We enrolled 1 subject with a small AAA and 1 subject with a rapidly expanding AAA, however, we were unable to recruit the number of subjects in each category to provide meaningful outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O2">
            <title>Small AAA's</title>
            <description>Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O3">
            <title>Rapidly Expanding AAA's</title>
            <description>Six subjects (three males and three females) with rapidly expanding AAAs (&gt;0.5cm over 6 months and/or &gt;1.0cm over 12 months).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O4">
            <title>AAA's Undergoing Treatment</title>
            <description>Six subjects (three males, AAA &gt;5.5cm and three females, AAA &gt;5.0cm) with AAAs that are indicated for treatment.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
        </group_list>
        <measure>
          <title>Standard Uptake Value (SUV)</title>
          <description>Aortic inflammation as demonstrated by uptake of radiotracer</description>
          <population>Recruitment was difficult. We enrolled 1 subject with a small AAA and 1 subject with a rapidly expanding AAA, however, we were unable to recruit the number of subjects in each category to provide meaningful outcomes.</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 group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rupture Potential Index (RPI)</title>
        <description>Rupture potential index (RPI) is defined as the ratio of the acting wall stress to the wall strength, and the maximum RPI for AAA represents its rupture risk. Currently, the primary factor considered for risk of human AAA rupture is aortic diameter; however, it is well documented that small AAAs (&lt;5cm) rupture, while many large AAAs (&gt;8cm) are incidentally discovered.&#xD;
We will assess the ability of imaging techniques to determine abdominal aortic aneurysm (AAA) rupture risk individually and in concert.</description>
        <time_frame>9-10 months</time_frame>
        <population>Recruitment was difficult. We enrolled 1 subject with a small AAA and 1 subject with a rapidly expanding AAA, however, we were unable to recruit the number of subjects in each category to provide meaningful outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O2">
            <title>Small AAA's</title>
            <description>Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O3">
            <title>Rapidly Expanding AAA's</title>
            <description>Six subjects (three males and three females) with rapidly expanding AAAs (&gt;0.5cm over 6 months and/or &gt;1.0cm over 12 months).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O4">
            <title>AAA's Undergoing Treatment</title>
            <description>Six subjects (three males, AAA &gt;5.5cm and three females, AAA &gt;5.0cm) with AAAs that are indicated for treatment.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
        </group_list>
        <measure>
          <title>Rupture Potential Index (RPI)</title>
          <description>Rupture potential index (RPI) is defined as the ratio of the acting wall stress to the wall strength, and the maximum RPI for AAA represents its rupture risk. Currently, the primary factor considered for risk of human AAA rupture is aortic diameter; however, it is well documented that small AAAs (&lt;5cm) rupture, while many large AAAs (&gt;8cm) are incidentally discovered.&#xD;
We will assess the ability of imaging techniques to determine abdominal aortic aneurysm (AAA) rupture risk individually and in concert.</description>
          <population>Recruitment was difficult. We enrolled 1 subject with a small AAA and 1 subject with a rapidly expanding AAA, however, we were unable to recruit the number of subjects in each category to provide meaningful outcomes.</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 group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Qualitative Comparison of SUV and RPI</title>
        <description>Finite element analysis (FEA) is a computerized numerical method used for the prediction of how the aorta may behave under stress. This software will be used to assess the same aortic volume comparing areas of greatest stress and lowest strength. Co-registration of images obtained by different imaging modalities will allow for comparison between imaging modalities. With direct co-registration of the data sets for each subject, qualitative comparisons will be made regarding areas of 18F-FDG and 11C-PBR28 uptake, as well as stress, strength, and RPI.</description>
        <time_frame>9-10 months</time_frame>
        <population>Because recruitment goals were not met, this computerized numerical method was not completed. We were only able to enroll 2 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O2">
            <title>Small AAA's</title>
            <description>Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O3">
            <title>Rapidly Expanding AAA's</title>
            <description>Six subjects (three males and three females) with rapidly expanding AAAs (&gt;0.5cm over 6 months and/or &gt;1.0cm over 12 months).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
          <group group_id="O4">
            <title>AAA's Undergoing Treatment</title>
            <description>Six subjects (three males, AAA &gt;5.5cm and three females, AAA &gt;5.0cm) with AAAs that are indicated for treatment.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Comparison of SUV and RPI</title>
          <description>Finite element analysis (FEA) is a computerized numerical method used for the prediction of how the aorta may behave under stress. This software will be used to assess the same aortic volume comparing areas of greatest stress and lowest strength. Co-registration of images obtained by different imaging modalities will allow for comparison between imaging modalities. With direct co-registration of the data sets for each subject, qualitative comparisons will be made regarding areas of 18F-FDG and 11C-PBR28 uptake, as well as stress, strength, and RPI.</description>
          <population>Because recruitment goals were not met, this computerized numerical method was not completed. We were only able to enroll 2 subjects.</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 group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day.</time_frame>
      <desc>We were only able to enroll 2 subjects.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="E2">
          <title>Small AAA's</title>
          <description>Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="E3">
          <title>Rapidly Expanding AAA's</title>
          <description>Six subjects (three males and three females) with rapidly expanding AAAs (&gt;0.5cm over 6 months and/or &gt;1.0cm over 12 months).&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</description>
        </group>
        <group group_id="E4">
          <title>AAA's Undergoing Treatment</title>
          <description>Six subjects (three males, AAA &gt;5.5cm and three females, AAA &gt;5.0cm) with AAAs that are indicated for treatment.&#xD;
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.&#xD;
Assess AAA rupture risk by PET-CTA scans: Assess AAA rupture risk by PET-CTA scans&#xD;
18F-fludeoxyglucose (FDG): Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging&#xD;
11C-PBR28: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging</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="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" 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="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" 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="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" 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>
    <point_of_contact>
      <name_or_title>Dr. Sean J. English</name_or_title>
      <organization>Washington University School of Medicine</organization>
      <phone>(314) 362-5707</phone>
      <email>sjenglish@wustl.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/NCT03231397
org study id: 201702141
nct id: NCT03231397
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or
      because they do not have an AAA (control group).

      The purpose of this research study is to further study, through FEA, changes that occur in
      the mechanical properties of the aortic wall. The investigator will compare two radiotracers,
      18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about
      inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging
      during the PET-CT scan. The investigator will also compare the results describing the
      mechanical properties of the AAA wall to the degree of inflammation in that wall as
      determined by PET-CT imaging to define new and better predictors of AAA growth and/or
      rupture.
Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or
      because they do not have an AAA (control group).

      The aorta serves as the main artery to supply blood flow to the body. It is approximately the
      size of a garden hose. Due to the effects of high blood pressure (hypertension),
      atherosclerosis (hardening of the arteries), and tobacco use, the aorta may widen and enlarge
      to form an aneurysm. An abdominal aortic aneurysm (AAA) is a dilation (enlargement) or
      ballooning out of a section of blood vessel caused by disease or weakness in the wall of the
      aorta below the level of the kidney arteries. As an AAA dilates and increases in size,
      rupture of the AAA may occur. AAA rupture carries a significant risk of death.

      Currently, aortic size is the primary factor used to assess aortic rupture risk. There are
      other imaging procedures (imaging modalities) that are being used and developed to assess AAA
      rupture risk. Finite element analysis (FEA) is a way to study the mechanical properties of
      the aortic wall, including areas of stress and strength that are used to calculate rupture
      risk. Positron Emission Tomography (PET) utilizes glucose (a form of sugar) labeled with a
      radioactivity to look at the metabolic activity and inflammation in the aortic wall.

      The purpose of this research study is to further study, through FEA, changes that occur in
      the mechanical properties of the aortic wall. The investigator will compare two radiotracers,
      18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about
      inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging
      during the PET-CT scan. The investigator will also compare the results describing the
      mechanical properties of the AAA wall to the degree of inflammation in that wall as
      determined by PET-CT imaging to define new and better predictors of AAA growth and/or
      rupture.

      The radioactive tracers that are used in this study are 18F-fludeoxyglucose (FDG) and
      11C-PBR28 (PBR) which stands for Peripheral Benzodiazepine Receptor. 11C-PBR28 is considered
      investigational, which means that it has not been approved by the U.S. Food and Drug
      Administration. FDG is an approved drug by the FDA, however in this study it is considered
      investigational.

      Goal: Twenty-four subjects will be recruited for this study. Six control subjects (three
      males and three females), will be considered. Control subjects will have known
      atherosclerosis, without aneurysmal disease. Six subjects (three males and three females)
      with small AAAs (diameter 3.0-4.5cm), six subjects (three males, AAA >5.5cm and three
      females, AAA >5.0cm) with AAAs that are indicated for treatment, and six subjects (three
      males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over
      12 months) will be considered.

      Subjects will have blood drawn to perform a genetic test that will look at genes and proteins
      to determine subject eligibility. Once the blood work is assessed for eligibility, subjects
      will undergo the PET-CT scan. The imaging will take approximately 3 hours to complete.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or because they do not have an AAA (control group).
The purpose of this research study is to further study, through FEA, changes that occur in the mechanical properties of the aortic wall. The investigator will compare two radiotracers, 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan. The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth and/or rupture.
primary purpose: Basic Science
masking: None (Open Label)
measure: Standard Uptake Value (SUV)
time frame: 1 day
description: Aortic inflammation as demonstrated by uptake of radiotracer
measure: Rupture Potential Index (RPI)
time frame: 9-10 months
description: Rupture potential index (RPI) is defined as the ratio of the acting wall stress to the wall strength, and the maximum RPI for AAA represents its rupture risk. Currently, the primary factor considered for risk of human AAA rupture is aortic diameter; however, it is well documented that small AAAs (<5cm) rupture, while many large AAAs (>8cm) are incidentally discovered.
We will assess the ability of imaging techniques to determine abdominal aortic aneurysm (AAA) rupture risk individually and in concert.
measure: Qualitative Comparison of SUV and RPI
time frame: 9-10 months
description: Finite element analysis (FEA) is a computerized numerical method used for the prediction of how the aorta may behave under stress. This software will be used to assess the same aortic volume comparing areas of greatest stress and lowest strength. Co-registration of images obtained by different imaging modalities will allow for comparison between imaging modalities. With direct co-registration of the data sets for each subject, qualitative comparisons will be made regarding areas of 18F-FDG and 11C-PBR28 uptake, as well as stress, strength, and RPI.
arm group label: Control Group
arm group type: Other
description: Six control subjects (three males and three females) with known atherosclerosis by standard clinical criteria without aneurysmal disease.
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
arm group label: Small AAA's
arm group type: Other
description: Six subjects (three males and three females) with small AAAs (diameter 3.0-4.5cm).
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
arm group label: Rapidly expanding AAA's
arm group type: Other
description: Six subjects (three males and three females) with rapidly expanding AAAs (>0.5cm over 6 months and/or >1.0cm over 12 months).
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
arm group label: AAA's undergoing treatment
arm group type: Other
description: Six subjects (three males, AAA >5.5cm and three females, AAA >5.0cm) with AAAs that are indicated for treatment.
To assess AAA rupture risk by PET-CTA scans, participants will undergo PET-CT scan using 11C-PBR28 and 18F-fludeoxyglucose (FDG) tracer. Participants will have a blood draw for genetic testing, pregnancy testing if female and creatinine testing.
intervention type: Drug
intervention name: Assess AAA rupture risk by PET-CTA scans
description: Assess AAA rupture risk by PET-CTA scans
arm group label: AAA's undergoing treatment
arm group label: Control Group
arm group label: Rapidly expanding AAA's
arm group label: Small AAA's
intervention type: Drug
intervention name: 18F-fludeoxyglucose (FDG)
description: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
arm group label: AAA's undergoing treatment
arm group label: Control Group
arm group label: Rapidly expanding AAA's
arm group label: Small AAA's
other name: 18F-FDG
intervention type: Diagnostic Test
intervention name: 11C-PBR28
description: Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
arm group label: AAA's undergoing treatment
arm group label: Control Group
arm group label: Rapidly expanding AAA's
arm group label: Small AAA's
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Sean J. English, MD
role: Principal Investigator
affiliation: Washington University School of Medicine, St. Louis, MO 63110
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
mesh term: Rupture
mesh term: Fluorodeoxyglucose F18
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 