<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/NCT02995642</url>
  </required_header>
  <id_info>
    <org_study_id>26885</org_study_id>
    <nct_id>NCT02995642</nct_id>
  </id_info>
  <brief_title>Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation</brief_title>
  <official_title>Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford 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>
      Stroke and abdominal aortic aneurysms (AAAs) are common and highly lethal vascular diseases.&#xD;
      Angiogenesis and infiltration of inflammatory cells such as macrophages may cause stroke and&#xD;
      AAAs.&#xD;
&#xD;
      The purpose of this study is to test PET/CT and PET/MRI imaging to specifically detect those&#xD;
      diseases using a new developed agent (18F-FPPRGD2) that can target angiogenesis and&#xD;
      macrophages.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      20 subjects with either carotid bifurcation stenosis of &gt;50% by ultrasound on at least one&#xD;
      side (10 patients) or advanced AAAs (10 patients) and surgical intervention planned will be&#xD;
      identified from physicians from the Division of Vascular Surgery at Stanford.&#xD;
&#xD;
      Either a PET/CT or a PET/MRI will be performed for each subject:&#xD;
&#xD;
        -  PET/CT scans will be performed in 3D mode using GE Discovery 600 or GE Discovery 690&#xD;
           scanners (GE Healthcare).&#xD;
&#xD;
        -  PET/MRI scans will be performed using the novel PET/MRI system at Stanford, including a&#xD;
           sensitive PET time-of-flight (TOF) scanner with an advanced 3T MRI scanner.&#xD;
&#xD;
      The study patients will receive an intravenous administration of 10mCi of the prescribed&#xD;
      radiotracer (18F-FPPRGD2). PET/CT or PET/MRI images will be obtained starting 45-60 minutes&#xD;
      after radiotracer administration. For PET/CT, each image acquisition will begin with a&#xD;
      non-contrast CT scan obtained from the vertex through the mid-thighs of the subjects. For&#xD;
      PET/MRI, non-contrast images of the carotid or aorta will be performed. PET imaging will&#xD;
      follow. Patient's vital signs will be monitored during the procedure and a physician will be&#xD;
      available if there is need for immediate medical attention. The PET images will be&#xD;
      reconstructed with a standard iterative algorithm using GE software release 5.0.&#xD;
&#xD;
      After the planned surgery, we will also assess the histopathological correlation between the&#xD;
      disease lesions and PET/CT or PET/MRI imaging characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Resources not secured&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SUVmax of 18F-FPPRGD2 uptake by lesions (carotid atherosclerotic plaque or AAA).</measure>
    <time_frame>Up to 60 minutes post-injection (at time of scan)</time_frame>
    <description>The arterial standardized uptake value (SUV) for carotid plaque or AAA will be calculated as the mean pixel activity within the region of interest (ROI).&#xD;
By averaging the SUV values for each artery slice, we will derived a mean SUV value for the entire artery (arterial SUV). This will be corrected for blood activity by division by the average blood SUV estimated from either the inferior vena cava or jugular vein to produce a blood-corrected artery SUV, known as the arterial tissue-to-background ratio (TBR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent agreement of 18F-FPPRGD2 PET with pathology</measure>
    <time_frame>Up to 60 minutes post-injection (at time of scan)</time_frame>
    <description>After the planned surgical procedure, the accuracy of 18F-FPPRGD2 PET as percent agreement with pathology (including angiogenesis and inflammation assessment) will be calculated.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Aortic Aneurysm, Abdominal</condition>
  <condition>Carotid Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>18F-FPPRGD2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects (with either carotid atherosclerosis stenosis or AAA) will receive a single intravenous injection of 10mCi of 18F-FPPRGD2 and will undergo positron emission tomography/computed tomography (PET/CT) or PET/MRI (PET/magnetic resonance imaging) imaging 45-60 minutes after injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-FPPRGD2</intervention_name>
    <description>One single intravenous injection.</description>
    <arm_group_label>18F-FPPRGD2</arm_group_label>
    <other_name>Fluorine-18-labeled RGD peptide [18F] FPA-PEG3-E[c(RGDyK)]2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Positron emission tomography</intervention_name>
    <description>Undergo 18F-FPPRGD2 PET/CT or PET/MRI</description>
    <arm_group_label>18F-FPPRGD2</arm_group_label>
    <other_name>PET</other_name>
    <other_name>PET scan</other_name>
    <other_name>tomography, emission computed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed tomography</intervention_name>
    <description>Undergo 18F-FPPRGD2 PET/CT or PET/MRI</description>
    <arm_group_label>18F-FPPRGD2</arm_group_label>
    <other_name>tomography, computed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Undergo 18F-FPPRGD2 PET/CT or PET/MRI</description>
    <arm_group_label>18F-FPPRGD2</arm_group_label>
    <other_name>MRI</other_name>
    <other_name>NMR imaging</other_name>
    <other_name>NMRI</other_name>
    <other_name>nuclear magnetic resonance imaging</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than 18 year-old at the time of radiotracer administration&#xD;
&#xD;
          -  Provides written informed consent&#xD;
&#xD;
          -  Patients diagnosed with either carotid artery stenosis or abdominal aortic aneurysms&#xD;
             (AAAs) as identified in Vascular Surgery, in whom a surgical procedure is scheduled&#xD;
&#xD;
          -  Able to remain still for duration of an imaging procedure (about one hour).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 year-old at the time of radiotracer administration&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prior carotid or abdominal surgery&#xD;
&#xD;
          -  History of radiation therapy to the neck and abdomen&#xD;
&#xD;
          -  MRI contraindications (including ferromagnetic objects or devices).&#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>Michael V. McConnell, MD, MSEE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mittra ES, Goris ML, Iagaru AH, Kardan A, Burton L, Berganos R, Chang E, Liu S, Shen B, Chin FT, Chen X, Gambhir SS. Pilot pharmacokinetic and dosimetric studies of (18)F-FPPRGD2: a PET radiopharmaceutical agent for imaging alpha(v)beta(3) integrin levels. Radiology. 2011 Jul;260(1):182-91. doi: 10.1148/radiol.11101139. Epub 2011 Apr 18.</citation>
    <PMID>21502381</PMID>
  </reference>
  <reference>
    <citation>Kitagawa T, Kosuge H, Chang E, James ML, Yamamoto T, Shen B, Chin FT, Gambhir SS, Dalman RL, McConnell MV. Integrin-targeted molecular imaging of experimental abdominal aortic aneurysms by (18)F-labeled Arg-Gly-Asp positron-emission tomography. Circ Cardiovasc Imaging. 2013 Nov;6(6):950-6. doi: 10.1161/CIRCIMAGING.113.000234. Epub 2013 Aug 30.</citation>
    <PMID>23995363</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Andrei Iagaru</investigator_full_name>
    <investigator_title>Associate Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center</investigator_title>
  </responsible_party>
  <keyword>Aortic Aneurysm, Abdominal</keyword>
  <keyword>Carotid Stenosis</keyword>
  <keyword>Atherosclerosis</keyword>
  <keyword>Angiogenesis</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Macrophages</keyword>
  <keyword>Positron-Emission Tomography</keyword>
  <keyword>Computerized tomography</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>(18F)FPP(RGD)2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arginyl-glycyl-aspartic acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995642
org study id: 26885
nct id: NCT02995642
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Stroke and abdominal aortic aneurysms (AAAs) are common and highly lethal vascular diseases.
      Angiogenesis and infiltration of inflammatory cells such as macrophages may cause stroke and
      AAAs.

      The purpose of this study is to test PET/CT and PET/MRI imaging to specifically detect those
      diseases using a new developed agent (18F-FPPRGD2) that can target angiogenesis and
      macrophages.
20 subjects with either carotid bifurcation stenosis of >50% by ultrasound on at least one
      side (10 patients) or advanced AAAs (10 patients) and surgical intervention planned will be
      identified from physicians from the Division of Vascular Surgery at Stanford.

      Either a PET/CT or a PET/MRI will be performed for each subject:

        -  PET/CT scans will be performed in 3D mode using GE Discovery 600 or GE Discovery 690
           scanners (GE Healthcare).

        -  PET/MRI scans will be performed using the novel PET/MRI system at Stanford, including a
           sensitive PET time-of-flight (TOF) scanner with an advanced 3T MRI scanner.

      The study patients will receive an intravenous administration of 10mCi of the prescribed
      radiotracer (18F-FPPRGD2). PET/CT or PET/MRI images will be obtained starting 45-60 minutes
      after radiotracer administration. For PET/CT, each image acquisition will begin with a
      non-contrast CT scan obtained from the vertex through the mid-thighs of the subjects. For
      PET/MRI, non-contrast images of the carotid or aorta will be performed. PET imaging will
      follow. Patient's vital signs will be monitored during the procedure and a physician will be
      available if there is need for immediate medical attention. The PET images will be
      reconstructed with a standard iterative algorithm using GE software release 5.0.

      After the planned surgery, we will also assess the histopathological correlation between the
      disease lesions and PET/CT or PET/MRI imaging characteristics.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUVmax of 18F-FPPRGD2 uptake by lesions (carotid atherosclerotic plaque or AAA).
time frame: Up to 60 minutes post-injection (at time of scan)
description: The arterial standardized uptake value (SUV) for carotid plaque or AAA will be calculated as the mean pixel activity within the region of interest (ROI).
By averaging the SUV values for each artery slice, we will derived a mean SUV value for the entire artery (arterial SUV). This will be corrected for blood activity by division by the average blood SUV estimated from either the inferior vena cava or jugular vein to produce a blood-corrected artery SUV, known as the arterial tissue-to-background ratio (TBR).
measure: Percent agreement of 18F-FPPRGD2 PET with pathology
time frame: Up to 60 minutes post-injection (at time of scan)
description: After the planned surgical procedure, the accuracy of 18F-FPPRGD2 PET as percent agreement with pathology (including angiogenesis and inflammation assessment) will be calculated.
arm group label: 18F-FPPRGD2
arm group type: Experimental
description: Subjects (with either carotid atherosclerosis stenosis or AAA) will receive a single intravenous injection of 10mCi of 18F-FPPRGD2 and will undergo positron emission tomography/computed tomography (PET/CT) or PET/MRI (PET/magnetic resonance imaging) imaging 45-60 minutes after injection.
intervention type: Drug
intervention name: 18F-FPPRGD2
description: One single intravenous injection.
arm group label: 18F-FPPRGD2
other name: Fluorine-18-labeled RGD peptide [18F] FPA-PEG3-E[c(RGDyK)]2
intervention type: Device
intervention name: Positron emission tomography
description: Undergo 18F-FPPRGD2 PET/CT or PET/MRI
arm group label: 18F-FPPRGD2
other name: PET
other name: PET scan
other name: tomography, emission computed
intervention type: Procedure
intervention name: Computed tomography
description: Undergo 18F-FPPRGD2 PET/CT or PET/MRI
arm group label: 18F-FPPRGD2
other name: tomography, computed
intervention type: Device
intervention name: Magnetic Resonance Imaging
description: Undergo 18F-FPPRGD2 PET/CT or PET/MRI
arm group label: 18F-FPPRGD2
other name: MRI
other name: NMR imaging
other name: NMRI
other name: nuclear magnetic resonance imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael V. McConnell, MD, MSEE
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: Mittra ES, Goris ML, Iagaru AH, Kardan A, Burton L, Berganos R, Chang E, Liu S, Shen B, Chin FT, Chen X, Gambhir SS. Pilot pharmacokinetic and dosimetric studies of (18)F-FPPRGD2: a PET radiopharmaceutical agent for imaging alpha(v)beta(3) integrin levels. Radiology. 2011 Jul;260(1):182-91. doi: 10.1148/radiol.11101139. Epub 2011 Apr 18.
PMID: 21502381
citation: Kitagawa T, Kosuge H, Chang E, James ML, Yamamoto T, Shen B, Chin FT, Gambhir SS, Dalman RL, McConnell MV. Integrin-targeted molecular imaging of experimental abdominal aortic aneurysms by (18)F-labeled Arg-Gly-Asp positron-emission tomography. Circ Cardiovasc Imaging. 2013 Nov;6(6):950-6. doi: 10.1161/CIRCIMAGING.113.000234. Epub 2013 Aug 30.
PMID: 23995363
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Andrei Iagaru
investigator title: Associate Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center
mesh term: Carotid Artery Diseases
mesh term: Aneurysm
mesh term: Atherosclerosis
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
mesh term: Inflammation
mesh term: Arginyl-glycyl-aspartic acid
sharing ipd: No