<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/NCT02229006</url>
  </required_header>
  <id_info>
    <org_study_id>ETM/365</org_study_id>
    <nct_id>NCT02229006</nct_id>
  </id_info>
  <brief_title>Sodium Fluoride Imaging of Abdominal Aortic Aneurysms</brief_title>
  <acronym>SoFIA3</acronym>
  <official_title>SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chief Scientist Office of the Scottish Government</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron&#xD;
      Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of&#xD;
      abdominal aortic aneurysm expansion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ruptured abdominal aortic aneurysms (AAAs) have a 90% mortality rate but there are currently&#xD;
      no accurate methods of establishing the risk of rupture for an individual patient with an&#xD;
      asymptomatic AAA. In vascular disease, microcalcification occurs in response to necrotic&#xD;
      inflammation. Using computed tomography and positron emission tomography (PET-CT), early&#xD;
      micro calcification can be identified using uptake of the radiotracer 18F-sodium fluoride.&#xD;
      This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears&#xD;
      to be indicative of necrotic and heavily inflamed tissue. The study investigators therefore&#xD;
      propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic&#xD;
      inflammation in AAA and predict AAA expansion. The study investigators will explore its value&#xD;
      as part of an ongoing clinical trial assessing the identification of macrophage activity&#xD;
      using magnetic resonance imaging - the MA3RS Study (ISRCTN76413758). Patients already&#xD;
      enrolled in the MA3RS Study will be recruited for the SoFIA3 study. Control patients with a&#xD;
      normal calibre aorta will be recruited from the National AAA Screening Programme.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm)</measure>
    <time_frame>0, 6, 12 months</time_frame>
    <description>The maximum AAA AP diameter on ultrasound will be obtained from time points below:&#xD;
At (or close to) the time of the study visit&#xD;
6 months following the study visit&#xD;
12 months following the study visit&#xD;
The maximum AP diameter will also be recorded on CTA performed at the time of study visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Co-localisation of 18F-NaF with USPIO uptake on MRI scanning</measure>
    <time_frame>At baseline</time_frame>
    <description>The data on USPIO uptake on MRI scanning will be derived from a separate study (MA3RS - MRI in AAA to predict Rupture or Survival, ISRCTN76413758). The proposed study described here (SoFIA3) will not involve any administration of USPIO.&#xD;
Regions of interest and uptake of 18F-NaF will be identified on PET-CT images acquired at baseline as part of this study (SoFIA3). These images will be co-registered to MRI data (uptake pre- and post-USPIO) which has already been obtained during the MA3RS Study. We will correlate the agreement between areas of significant 18F-NaF uptake on PET-CT (representing areas of active calcification) and areas of significant USPIO uptake on MRI (representing areas of active macrophage activity).&#xD;
This is an exploratory analysis which will take advantage of data already obtained through the MA3RS Study, which is a separate study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Co-localisation of 18F-NaF with histological evidence of active calcification, necrotic inflammation and proteolytic degradation of the aneurysm wall</measure>
    <time_frame>At baseline</time_frame>
    <description>Uptake of 18F-NaF will be identified on PET-CT scans that are acquired as part of the study visit. We will take advantage of histological tissue specimens that will be collected as part of the separate MA3RS Study (patients enrolled in the MA3RS Study who undergo AAA repair give consent to tissue samples being take and analysed).&#xD;
We will take advantage of histological data that is already obtained from the MA3RS study and use this to correlate histological areas of inflammation with areas of active calcification on PET-CT.</description>
  </other_outcome>
  <other_outcome>
    <measure>Relationship with areas of high wall stress (finite element analysis)</measure>
    <time_frame>At baseline</time_frame>
    <description>As part of the MA3RS Study, patients will undergo CTA scans at baseline and 24 months. These are being used by other members of the team in the development of novel imaging techniques to quantify areas of high wall stress, through finite element analysis.&#xD;
The extra CTA and calcium scoring scans acquired as part of SoFIA3 (which could be at any time following the first MA3RS CTA) may contribute to this image analysis technique.</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of 18F-NaF uptake in patients with AAA versus control patients</measure>
    <time_frame>At baseline</time_frame>
    <description>We will compare objective measures of tracer uptake in AAA vs control aorta</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">96</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>Aneurysm surveillance</arm_group_label>
    <description>Radiation: 18F-NaF PET-CT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control patients</arm_group_label>
    <description>Radiation: 18F-NaF PET-CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>18F-NaF PET-CT</intervention_name>
    <arm_group_label>Aneurysm surveillance</arm_group_label>
    <arm_group_label>Control patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Case: patients with abdominal aortic aneurysm enrolled in the hospital ultrasound&#xD;
        surveillance programme Control: patients with normal calibre aorta as demonstrated from an&#xD;
        ultrasound performed as part of the National AAA Screening Programme&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (AAA patients):&#xD;
&#xD;
          -  Patients already enrolled in the MA3RS study (ISRCTN76413758)&#xD;
&#xD;
          -  Patients with abdominal aortic aneurysm with AP diameter &gt;40 mm on ultrasound&#xD;
&#xD;
          -  &gt;50 years of age&#xD;
&#xD;
        Inclusion Criteria (control patients):&#xD;
&#xD;
          -  Patients with abdominal aorta with AP diameter &lt;30 mm on ultrasound&#xD;
&#xD;
          -  &gt;50 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients expected to undergo imminent AAA repair&#xD;
&#xD;
          -  Patients who refuse or are unable to give informed consent&#xD;
&#xD;
          -  Women of child-bearing potential without contraception&#xD;
&#xD;
          -  Patients who are unable to undergo PET-CT scan&#xD;
&#xD;
          -  Patients with collagen vascular disease&#xD;
&#xD;
          -  Intercurrent illness, malignancy or comorbidity with life expectancy &lt;1 year&#xD;
&#xD;
          -  Renal dysfunction (eGFR &lt;30ml/min/1.73m2)&#xD;
&#xD;
          -  Contraindication to PET-CT or CTA&#xD;
&#xD;
          -  Iodine allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachael O Forsythe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Edinburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David E Newby, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Edinburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Infirmary of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic aneurysm, abdominal</keyword>
  <keyword>Sodium Fluoride</keyword>
  <keyword>Positron Emission Tomography</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>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02229006
org study id: ETM/365
nct id: NCT02229006
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron
      Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of
      abdominal aortic aneurysm expansion.
Ruptured abdominal aortic aneurysms (AAAs) have a 90% mortality rate but there are currently
      no accurate methods of establishing the risk of rupture for an individual patient with an
      asymptomatic AAA. In vascular disease, microcalcification occurs in response to necrotic
      inflammation. Using computed tomography and positron emission tomography (PET-CT), early
      micro calcification can be identified using uptake of the radiotracer 18F-sodium fluoride.
      This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears
      to be indicative of necrotic and heavily inflamed tissue. The study investigators therefore
      propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic
      inflammation in AAA and predict AAA expansion. The study investigators will explore its value
      as part of an ongoing clinical trial assessing the identification of macrophage activity
      using magnetic resonance imaging - the MA3RS Study (ISRCTN76413758). Patients already
      enrolled in the MA3RS Study will be recruited for the SoFIA3 study. Control patients with a
      normal calibre aorta will be recruited from the National AAA Screening Programme.
observational model: Case-Control
time perspective: Prospective
measure: Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm)
time frame: 0, 6, 12 months
description: The maximum AAA AP diameter on ultrasound will be obtained from time points below:
At (or close to) the time of the study visit
6 months following the study visit
12 months following the study visit
The maximum AP diameter will also be recorded on CTA performed at the time of study visit.
measure: Co-localisation of 18F-NaF with USPIO uptake on MRI scanning
time frame: At baseline
description: The data on USPIO uptake on MRI scanning will be derived from a separate study (MA3RS - MRI in AAA to predict Rupture or Survival, ISRCTN76413758). The proposed study described here (SoFIA3) will not involve any administration of USPIO.
Regions of interest and uptake of 18F-NaF will be identified on PET-CT images acquired at baseline as part of this study (SoFIA3). These images will be co-registered to MRI data (uptake pre- and post-USPIO) which has already been obtained during the MA3RS Study. We will correlate the agreement between areas of significant 18F-NaF uptake on PET-CT (representing areas of active calcification) and areas of significant USPIO uptake on MRI (representing areas of active macrophage activity).
This is an exploratory analysis which will take advantage of data already obtained through the MA3RS Study, which is a separate study.
measure: Co-localisation of 18F-NaF with histological evidence of active calcification, necrotic inflammation and proteolytic degradation of the aneurysm wall
time frame: At baseline
description: Uptake of 18F-NaF will be identified on PET-CT scans that are acquired as part of the study visit. We will take advantage of histological tissue specimens that will be collected as part of the separate MA3RS Study (patients enrolled in the MA3RS Study who undergo AAA repair give consent to tissue samples being take and analysed).
We will take advantage of histological data that is already obtained from the MA3RS study and use this to correlate histological areas of inflammation with areas of active calcification on PET-CT.
measure: Relationship with areas of high wall stress (finite element analysis)
time frame: At baseline
description: As part of the MA3RS Study, patients will undergo CTA scans at baseline and 24 months. These are being used by other members of the team in the development of novel imaging techniques to quantify areas of high wall stress, through finite element analysis.
The extra CTA and calcium scoring scans acquired as part of SoFIA3 (which could be at any time following the first MA3RS CTA) may contribute to this image analysis technique.
measure: Comparison of 18F-NaF uptake in patients with AAA versus control patients
time frame: At baseline
description: We will compare objective measures of tracer uptake in AAA vs control aorta
arm group label: Aneurysm surveillance
description: Radiation: 18F-NaF PET-CT
arm group label: Control patients
description: Radiation: 18F-NaF PET-CT
intervention type: Radiation
intervention name: 18F-NaF PET-CT
arm group label: Aneurysm surveillance
arm group label: Control patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rachael O Forsythe, MD
role: Principal Investigator
affiliation: University of Edinburgh
last name: David E Newby, MD PhD
role: Study Director
affiliation: University of Edinburgh
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal