<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/NCT04441489</url>
  </required_header>
  <id_info>
    <org_study_id>PET-COVID</org_study_id>
    <nct_id>NCT04441489</nct_id>
  </id_info>
  <brief_title>Assessment of Lung Inflammation With FDG PET/CT in COVID-19</brief_title>
  <official_title>Assessment of Lung Inflammation With FDG PET/CT in COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Princesse Grace</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Princesse Grace</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to assess the inflammatory status at the presumed peak of the&#xD;
      inflammatory phase in non-critically ill patients requiring admission for COVID-19. Patients&#xD;
      admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled. All&#xD;
      patients had an initial chest CT-scan for diagnosis on admission and a second chest CT-scan&#xD;
      for follow-up concomitant with a FDG PET/CT between day 6 and day 14 after the onset of&#xD;
      symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      [18F]-2-fluoro-2-deoxy-D-glucose PET/CT (FDG PET/CT) is a sensitive and quantitative technic&#xD;
      for detecting inflammatory process. Glucose uptake is correlated with increased anaerobic&#xD;
      glycolysis seen in activated inflammatory cells such as monocytes, lymphocytes and&#xD;
      granulocytes.&#xD;
&#xD;
      The aim of the study was to assess the inflammatory status at the presumed peak of the&#xD;
      inflammatory phase in non-critically ill patients requiring admission for COVID-19.&#xD;
&#xD;
      Patients were included if COVID-19 was confirmed according to the WHO guidance (11) by a&#xD;
      positive result of RT-PCR assay of nasal and pharyngeal swabs, if they were hospitalized&#xD;
      during the time period from day 6 to day 14 of the onset of symptoms, and if their initial&#xD;
      (on admission) chest CT-scan presented ground-glass opacities (GGO) or consolidation.&#xD;
&#xD;
      Group of 13 consecutive patients prospectively enrolled. All patients had an initial chest&#xD;
      CT-scan for diagnosis on admission and a second chest CT-scan for follow-up concomitant with&#xD;
      a FDG PET/CT between day 6 and day 14 after the onset of symptoms.&#xD;
&#xD;
      Based on the changes between the two chest CT, patients were classified as follows:&#xD;
&#xD;
        -  CT worsening: increase of CT abnormalities extent &gt; 20% or additional GGO or&#xD;
           consolidation. Conversion of GGO into consolidation was not considered as additional&#xD;
           finding.&#xD;
&#xD;
        -  CT stability: changes of CT abnormalities extent ≤ 20% without additional GGO or&#xD;
           consolidation.&#xD;
&#xD;
        -  CT improvement: decrease of CT abnormalities extent &gt; 20% without additional GGO or&#xD;
           consolidation.&#xD;
&#xD;
      Based on FDG PET/CT imaging, patients' profiles were classified as follows:&#xD;
&#xD;
        -  Inflammatory: lungs hypermetabolic volume ≥ 50 ml and / or SUVmax ≥ 7&#xD;
&#xD;
        -  Low inflammatory: lungs hypermetabolic volume &lt; 50 ml and / or SUVmax&lt; 7 Patients'&#xD;
           short-term clinical outcome was classified as follows: worsening, stability,&#xD;
           improvement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2020</start_date>
  <completion_date type="Actual">May 27, 2020</completion_date>
  <primary_completion_date type="Actual">May 3, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary endpoint</measure>
    <time_frame>Day 6 to Day 14</time_frame>
    <description>Amount of FDG pathological uptake expressed by maximum signal intensity standardized uptake values (SUVmax)</description>
  </primary_outcome>
  <enrollment type="Actual">13</enrollment>
  <condition>COVID-19</condition>
  <condition>FDG PET/CT</condition>
  <condition>Inflammation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively&#xD;
        enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were included if COVID-19 was confirmed according to the WHO guidance (11) by&#xD;
             a positive result of RT-PCR assay of nasal and pharyngeal swabs, if they were&#xD;
             hospitalized during the time period from day 6 to day 14 of the onset of symptoms, and&#xD;
             if their initial (on admission) chest CT-scan presented ground-glass opacities (GGO)&#xD;
             or consolidation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients could not be included if their medical condition was unstable or precluded a&#xD;
             safe transfer to the nuclear medicine department, if they were under mechanical&#xD;
             ventilation (either non-invasive or invasive), if they were initially referred to the&#xD;
             critical care unit, and in case of a pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Princesse Grace</name>
      <address>
        <city>Monaco</city>
        <country>Monaco</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Monaco</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Inflammation</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/NCT04441489
org study id: PET-COVID
nct id: NCT04441489
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to assess the inflammatory status at the presumed peak of the
      inflammatory phase in non-critically ill patients requiring admission for COVID-19. Patients
      admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled. All
      patients had an initial chest CT-scan for diagnosis on admission and a second chest CT-scan
      for follow-up concomitant with a FDG PET/CT between day 6 and day 14 after the onset of
      symptoms.
[18F]-2-fluoro-2-deoxy-D-glucose PET/CT (FDG PET/CT) is a sensitive and quantitative technic
      for detecting inflammatory process. Glucose uptake is correlated with increased anaerobic
      glycolysis seen in activated inflammatory cells such as monocytes, lymphocytes and
      granulocytes.

      The aim of the study was to assess the inflammatory status at the presumed peak of the
      inflammatory phase in non-critically ill patients requiring admission for COVID-19.

      Patients were included if COVID-19 was confirmed according to the WHO guidance (11) by a
      positive result of RT-PCR assay of nasal and pharyngeal swabs, if they were hospitalized
      during the time period from day 6 to day 14 of the onset of symptoms, and if their initial
      (on admission) chest CT-scan presented ground-glass opacities (GGO) or consolidation.

      Group of 13 consecutive patients prospectively enrolled. All patients had an initial chest
      CT-scan for diagnosis on admission and a second chest CT-scan for follow-up concomitant with
      a FDG PET/CT between day 6 and day 14 after the onset of symptoms.

      Based on the changes between the two chest CT, patients were classified as follows:

        -  CT worsening: increase of CT abnormalities extent > 20% or additional GGO or
           consolidation. Conversion of GGO into consolidation was not considered as additional
           finding.

        -  CT stability: changes of CT abnormalities extent ≤ 20% without additional GGO or
           consolidation.

        -  CT improvement: decrease of CT abnormalities extent > 20% without additional GGO or
           consolidation.

      Based on FDG PET/CT imaging, patients' profiles were classified as follows:

        -  Inflammatory: lungs hypermetabolic volume ≥ 50 ml and / or SUVmax ≥ 7

        -  Low inflammatory: lungs hypermetabolic volume < 50 ml and / or SUVmax< 7 Patients'
           short-term clinical outcome was classified as follows: worsening, stability,
           improvement.
observational model: Case-Only
time perspective: Prospective
measure: Primary endpoint
time frame: Day 6 to Day 14
description: Amount of FDG pathological uptake expressed by maximum signal intensity standardized uptake values (SUVmax)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Monaco
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Inflammation