xml: <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/NCT05994768</url>
    </required_header>
    <id_info>
      <org_study_id>2023PI003</org_study_id>
      <nct_id>NCT05994768</nct_id>
    </id_info>
    <brief_title>18F-FDG Tomography and Labeled Leukocyte Scintigraphy</brief_title>
    <acronym>OEN</acronym>
    <official_title>Comparison of the Performance of 18F-FDG PET/CT With That of Labeled Leukocyte Scintigraphy in the Follow-up of Malignant Otitis Externa.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Central Hospital, Nancy, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Central Hospital, Nancy, France</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>
        The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled&#xD;
        leukocyte scintigraphy in patients with a malignant otitis externa.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The management of malignant otitis externa (MEO) is a major issue in patients who are often&#xD;
        polypathological and fragile. Appropriate antibiotic therapy must be started quickly after&#xD;
        the diagnosis is made and followed for a period of at least 6 weeks. Imaging plays a major&#xD;
        role in assessing the extent of the infection and especially healing, after 6 weeks of&#xD;
        antibiotic therapy. The persistence of an infection at the end of the treatment, observed in&#xD;
        imaging, will allow a change of antibiotic line. This study consists in studying in a&#xD;
        population affected by an OEM, the performance of PET/CT with 18F-FDG compared to&#xD;
        scintigraphy with labeled leukocytes. The usefulness of the latter in the follow-up of the&#xD;
        pathology after antibiotic therapy has already been proven in the literature. The study will&#xD;
        aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte&#xD;
        scintigraphy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 18, 2020</start_date>
    <completion_date type="Anticipated">August 18, 2023</completion_date>
    <primary_completion_date type="Actual">July 12, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>18F-FDG positron emission tomography</measure>
      <time_frame>one day</time_frame>
      <description>measurement of standard uptake value (max and mean)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Labeled leukocyte scintigraphy</measure>
      <time_frame>one day</time_frame>
      <description>measurement of standard uptake value (max and mean)</description>
    </primary_outcome>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Malignant Otitis Externa</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>18F-FDG PET/CT</intervention_name>
      <description>Patients who underwent an 18F-FDG PET/CT examination and a labeled leukocyte scintigraphy before and after antibiotic therapy in the case of management of an EO.</description>
      <other_name>scintigraphy with labeled leukocytes</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who underwent an 18F-FDG positron emission tomography examination and a labeled&#xD;
          leukocyte scintigraphy before and after antibiotic therapy in the case of management of an&#xD;
          malignant otitis externa.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with malignant otitis externa who received a 18F-FDG positron emission&#xD;
               tomography and a labelled leukocyte scintigraphy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients who refuse to have their imaging data used&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>VERONIQUE ROCH, MSc</last_name>
      <phone>383154276</phone>
      <phone_ext>+33</phone_ext>
      <email>v.roch@chru-nancy.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>ANNE-SOPHIE HUE, MSc</last_name>
      <phone>383153475</phone>
      <phone_ext>+33</phone_ext>
      <email>a.hue@chru-nancy.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Verger Antoine</name>
        <address>
          <city>Vandoeuvre les Nancy cedex</city>
          <zip>54511</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Antoine VERGER, MD, PhD</last_name>
        <phone>0383154276</phone>
        <email>a.verger@chru-nancy.fr</email>
      </contact>
      <investigator>
        <last_name>Antoine VERGER, MD,PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
      <investigator_full_name>Antoine VERGER</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Otitis</mesh_term>
      <mesh_term>Otitis Externa</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>
  
  
text: 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/NCT05994768
  org study id: 2023PI003
  nct id: NCT05994768
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled
        leukocyte scintigraphy in patients with a malignant otitis externa.
  The management of malignant otitis externa (MEO) is a major issue in patients who are often
        polypathological and fragile. Appropriate antibiotic therapy must be started quickly after
        the diagnosis is made and followed for a period of at least 6 weeks. Imaging plays a major
        role in assessing the extent of the infection and especially healing, after 6 weeks of
        antibiotic therapy. The persistence of an infection at the end of the treatment, observed in
        imaging, will allow a change of antibiotic line. This study consists in studying in a
        population affected by an OEM, the performance of PET/CT with 18F-FDG compared to
        scintigraphy with labeled leukocytes. The usefulness of the latter in the follow-up of the
        pathology after antibiotic therapy has already been proven in the literature. The study will
        aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte
        scintigraphy.
  observational model: Other
  time perspective: Retrospective
  measure: 18F-FDG positron emission tomography
  time frame: one day
  description: measurement of standard uptake value (max and mean)
  measure: Labeled leukocyte scintigraphy
  time frame: one day
  description: measurement of standard uptake value (max and mean)
  intervention type: Other
  intervention name: 18F-FDG PET/CT
  description: Patients who underwent an 18F-FDG PET/CT examination and a labeled leukocyte scintigraphy before and after antibiotic therapy in the case of management of an EO.
  other name: scintigraphy with labeled leukocytes
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: VERONIQUE ROCH, MSc
  phone: 383154276
  phone ext: +33
  email: v.roch@chru-nancy.fr
  last name: ANNE-SOPHIE HUE, MSc
  phone: 383153475
  phone ext: +33
  email: a.hue@chru-nancy.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Central Hospital, Nancy, France
  investigator full name: Antoine VERGER
  investigator title: MD, PhD
  mesh term: Otitis
  mesh term: Otitis Externa
  mesh term: Fluorodeoxyglucose F18