<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/NCT03015818</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0137</org_study_id>
    <nct_id>NCT03015818</nct_id>
  </id_info>
  <brief_title>Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)</brief_title>
  <acronym>TEP-SVD</acronym>
  <official_title>Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Structural valve dysfunction (SVD) is the most common and life threatening complication in&#xD;
      patients treated by aortic valve replacement. A calcification process is frequently involved&#xD;
      in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic&#xD;
      phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than&#xD;
      a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with&#xD;
      18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.&#xD;
&#xD;
      This study will include patients with echocardiography-confirmed SVD. Echocardiographic&#xD;
      parameters and other current parameters analyzed in SVD patients such as bioprosthesis&#xD;
      calcium scoring derived from CT will be compared to 18F-Fluoride activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">May 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 3, 2019</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>18F-Fluoride activity</measure>
    <time_frame>The day of the inclusion</time_frame>
    <description>18F-Fluoride activity in valvular tissue will be determined by a tissue to bloodpool ratio of SUV (TBR). Patients will be divided in two groups : moderate SVD (EOA ≥ 0.8 and ≤ 1.2 cm²), and severe SVD (EOA ≤ 0.8 cm²), and TBR will be compared between the two groups, determined at time of inclusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TBR in 18F-FDG</measure>
    <time_frame>6 months</time_frame>
    <description>TBR in 18F-FDG will be compared between the two groups to analyze the inflammatory activity part in the SVD process</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Both 18F-Fluoride and 18F-FDG TBR correlation</measure>
    <time_frame>6 months</time_frame>
    <description>Both 18F-Fluoride and 18F-FDG TBR will be correlated with bioprosthesis calcium scoring and the following echocardiographic bioprosthesis function parameters : aortic regurgitation grade (none, trace, mild, moderate, severe) ; trans-valvular maximal velocity (m/s) ; mean trans-valvular gradient (mm Hg) ; EOA (cm²) ; visual echographic degenerescence score.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Aortic Bioprosthesis Structural Valve Dysfunction</condition>
  <arm_group>
    <arm_group_label>18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT</intervention_name>
    <description>18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT</description>
    <arm_group_label>18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  SVD defined on echocardiography by an alteration of bioprosthesis leaflets function&#xD;
             with a mean transvalvular gradient &gt; 20 mmHg and maximal velocity ≥ 3 m/s and&#xD;
             effective orifice area ≤1.2 cm², and/or an aortic regurgitation more or equal to grade&#xD;
             2 on 4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Concurrent antibiotherapy&#xD;
&#xD;
          -  Certain infectious endocarditis&#xD;
&#xD;
          -  Concurrent anti-inflammatory therapy, including corticosteroid therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 15, 2020</last_update_submitted>
  <last_update_submitted_qc>January 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
    <mesh_term>Fluorides</mesh_term>
  </intervention_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/NCT03015818
org study id: RC16_0137
nct id: NCT03015818
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Structural valve dysfunction (SVD) is the most common and life threatening complication in
      patients treated by aortic valve replacement. A calcification process is frequently involved
      in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic
      phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than
      a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with
      18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.

      This study will include patients with echocardiography-confirmed SVD. Echocardiographic
      parameters and other current parameters analyzed in SVD patients such as bioprosthesis
      calcium scoring derived from CT will be compared to 18F-Fluoride activity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: 18F-Fluoride activity
time frame: The day of the inclusion
description: 18F-Fluoride activity in valvular tissue will be determined by a tissue to bloodpool ratio of SUV (TBR). Patients will be divided in two groups : moderate SVD (EOA ≥ 0.8 and ≤ 1.2 cm²), and severe SVD (EOA ≤ 0.8 cm²), and TBR will be compared between the two groups, determined at time of inclusion.
measure: TBR in 18F-FDG
time frame: 6 months
description: TBR in 18F-FDG will be compared between the two groups to analyze the inflammatory activity part in the SVD process
measure: Both 18F-Fluoride and 18F-FDG TBR correlation
time frame: 6 months
description: Both 18F-Fluoride and 18F-FDG TBR will be correlated with bioprosthesis calcium scoring and the following echocardiographic bioprosthesis function parameters : aortic regurgitation grade (none, trace, mild, moderate, severe) ; trans-valvular maximal velocity (m/s) ; mean trans-valvular gradient (mm Hg) ; EOA (cm²) ; visual echographic degenerescence score.
arm group label: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
arm group type: Experimental
intervention type: Other
intervention name: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
description: 18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT
arm group label: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Calcium
mesh term: Fluorides