<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/NCT02251262</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2013/31</org_study_id>
    <nct_id>NCT02251262</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of 18FDG-PET-CT for Pacing or Defibrillation Lead Infection</brief_title>
  <acronym>ENDOTEP</acronym>
  <official_title>Assessment of Diagnostic Accuracy of 18FDG-PET-CT in Patients With Suspicion of Pacing or Defibrillation Lead Infection: a Prospective Multi-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With aging of the general population and broadening indications, the number of pacemaker&#xD;
      recipients is steadily increasing. The incidence of infections of the implanted material, a&#xD;
      dreaded major complication, is also rising. The diagnosis is evident in presence of an&#xD;
      abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to&#xD;
      the lead. On the other hand, a proportion of patients present with less specific clinical&#xD;
      manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious&#xD;
      disorder of unknown origin despite detailed investigations. Without proof of lead infection,&#xD;
      removal of the system without confirmation of its infection is usually proposed, despite the&#xD;
      known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive&#xD;
      culture of the leads implies that the leads were involved in the infectious process. In&#xD;
      recent years, 18FDG-PET-CT scan has made promising contributions in different areas including&#xD;
      imaging to detect infection at different organ sites. Absence of hyperfixation of the lead,&#xD;
      identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system&#xD;
      infection.&#xD;
&#xD;
      The extraction of intracardiac implanted material, when it is indicated by the current&#xD;
      standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients,&#xD;
      even when they did not receive antibiotics before extraction.&#xD;
&#xD;
      The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current&#xD;
      strategy may avoid or reduce these false-positives.&#xD;
&#xD;
      Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to&#xD;
      avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive&#xD;
      value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at&#xD;
      providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its&#xD;
      sensitivity.&#xD;
&#xD;
      For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with&#xD;
      suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit;&#xD;
      secondarily, an intervention for the extraction of the intra-cardiac material, under general&#xD;
      anesthesia, will be practiced and then a bacteriological culture for extracted material will&#xD;
      be required.&#xD;
&#xD;
      The end of study visit is complete the last day of material extraction. The follow up will&#xD;
      last 2 to 7 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2015</start_date>
  <completion_date type="Actual">June 19, 2018</completion_date>
  <primary_completion_date type="Actual">June 19, 2018</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A semi-quantitative visual interpretation of 18FDG-PET-CT in the diagnosis of infection of intracardiac device.</measure>
    <time_frame>up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy)</time_frame>
    <description>Index tests will be interpreted by nuclear medicine physician from the center where the patient was included with a semi-quantitative visual score.&#xD;
Moreover, all 18FDG-PET-CT recordings will be sent to the coordinating center for centralized interpretation blind to the preceding one.&#xD;
All 18FDG-PET-CT recordings will be stored until interpretation, and not used for the clinical management of the patient.&#xD;
Index test interpretations will be carried out blind to any other information on the patient (clinical, biology,…).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Infections of the Implanted Material</condition>
  <condition>Endocarditis</condition>
  <arm_group>
    <arm_group_label>Whole-body 18FDG-PET-CT scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Whole-body 18FDG-PET-CT scan</intervention_name>
    <description>18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.</description>
    <arm_group_label>Whole-body 18FDG-PET-CT scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Patient referred for extraction of cardiac material (box and lead(s)) in the context&#xD;
             of suspicion of material infection, including a patient with pocket infection.&#xD;
&#xD;
          -  Possibility of carrying out PET-CT no more than 48 hours before extraction (or,&#xD;
             exceptionally, no more than 7 days if the patient is not under antibiotic therapy).&#xD;
&#xD;
          -  Informed written consent&#xD;
&#xD;
          -  Affiliation to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patients with recent implantation (less than 2 months)&#xD;
&#xD;
          -  Subjects placed under judicial protection&#xD;
&#xD;
          -  Subjects participating in another study that includes an exclusion period on-going at&#xD;
             the time of screening.&#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>Pierre BORDACHAR, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul PEREZ, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Grenoble - Hôpital A. Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille - Hôpital R. Salengro</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HM - Hôpital La Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy - Hôpital de Brabois</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pacemaker</keyword>
  <keyword>Endocarditis</keyword>
  <keyword>18FDG-PET-CT</keyword>
  <keyword>Diagnostic accuracy</keyword>
  <keyword>Pacing or defibrillation lead</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Endocarditis</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>
  <!-- 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/NCT02251262
org study id: CHUBX 2013/31
nct id: NCT02251262
lead sponsor: 
has dmc: No
With aging of the general population and broadening indications, the number of pacemaker
      recipients is steadily increasing. The incidence of infections of the implanted material, a
      dreaded major complication, is also rising. The diagnosis is evident in presence of an
      abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to
      the lead. On the other hand, a proportion of patients present with less specific clinical
      manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious
      disorder of unknown origin despite detailed investigations. Without proof of lead infection,
      removal of the system without confirmation of its infection is usually proposed, despite the
      known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive
      culture of the leads implies that the leads were involved in the infectious process. In
      recent years, 18FDG-PET-CT scan has made promising contributions in different areas including
      imaging to detect infection at different organ sites. Absence of hyperfixation of the lead,
      identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system
      infection.

      The extraction of intracardiac implanted material, when it is indicated by the current
      standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients,
      even when they did not receive antibiotics before extraction.

      The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current
      strategy may avoid or reduce these false-positives.

      Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to
      avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive
      value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at
      providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its
      sensitivity.

      For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with
      suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit;
      secondarily, an intervention for the extraction of the intra-cardiac material, under general
      anesthesia, will be practiced and then a bacteriological culture for extracted material will
      be required.

      The end of study visit is complete the last day of material extraction. The follow up will
      last 2 to 7 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: A semi-quantitative visual interpretation of 18FDG-PET-CT in the diagnosis of infection of intracardiac device.
time frame: up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy)
description: Index tests will be interpreted by nuclear medicine physician from the center where the patient was included with a semi-quantitative visual score.
Moreover, all 18FDG-PET-CT recordings will be sent to the coordinating center for centralized interpretation blind to the preceding one.
All 18FDG-PET-CT recordings will be stored until interpretation, and not used for the clinical management of the patient.
Index test interpretations will be carried out blind to any other information on the patient (clinical, biology,…).
arm group label: Whole-body 18FDG-PET-CT scan
arm group type: Experimental
description: 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.
intervention type: Device
intervention name: Whole-body 18FDG-PET-CT scan
description: 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.
arm group label: Whole-body 18FDG-PET-CT scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre BORDACHAR, MD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
last name: Paul PEREZ, MD, PhD
role: Study Chair
affiliation: University Hospital, Bordeaux
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Endocarditis
mesh term: Fluorodeoxyglucose F18