<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/NCT04437927</url>
  </required_header>
  <id_info>
    <org_study_id>20-11</org_study_id>
    <nct_id>NCT04437927</nct_id>
  </id_info>
  <brief_title>Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose Metabolism in 18F-FDG PET/CT</brief_title>
  <official_title>Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose</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>
    <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>
      There is increasing evidence that [18F]-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT is useful&#xD;
      in the identification and treatment of disease processes that involve cardiac inflammation&#xD;
      and infection. Current applications include imaging intra-cardiac device and prosthetic valve&#xD;
      infections, evaluating patients with known or suspected cardiac sarcoidosis or other&#xD;
      inflammatory cardiomyopathies.&#xD;
&#xD;
      However, because normal myocardium can metabolize both glucose and free fatty acids (FFAs),&#xD;
      physiological accumulation of FDG in the myocardium can interfere with the recognition of&#xD;
      abnormal FDG uptake.&#xD;
&#xD;
      The use of a low-carbohydrate diet with a prolonged fast ≥ 12 h nutrition followed by a fast&#xD;
      of at least four hours is the effective preparation recommended to suppress physiological&#xD;
      myocardial FDG uptake.&#xD;
&#xD;
      However, the rate of suppression of physiological accumulation of FDG with this method in our&#xD;
      center is only 50%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodology :&#xD;
&#xD;
      Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled,&#xD;
      compared to a group with the last 30 patients referred for cardiac FDG PET in the nuclear&#xD;
      medicine department of the Centre Hospitalier Princesse Grace.&#xD;
&#xD;
      Procedures :&#xD;
&#xD;
      Infusion of 100mL lipid emulsion for intravenous two hours before cardiac FDG PET/CT:&#xD;
&#xD;
        -  Infusion rate will be 20 mL/hour during the initial 10 minutes (3 mL Intralipid)&#xD;
&#xD;
        -  The dose will be then increased to 40 mL/hour for the next 10 minutes (6 mL Intralipid)&#xD;
&#xD;
        -  Finally, for the next 50 minutes the dose will be increased to 100 mL/hour (83mL&#xD;
           Intralipid)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2020</start_date>
  <completion_date type="Actual">November 6, 2020</completion_date>
  <primary_completion_date type="Actual">November 6, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Uptake in the heart scoring according to a visual scale</measure>
    <time_frame>day 1</time_frame>
    <description>Score of 0: complete myocardial suppression&#xD;
Score of 1: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial interpretation but not cardiac valves.&#xD;
Score of 2: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and mitral or aortic valve interpretations.&#xD;
Score of 3: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and both mitral and aortic valves interpretations.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Metabolic Preparation</condition>
  <condition>Myocardial Inflammation</condition>
  <arm_group>
    <arm_group_label>Prospective patients</arm_group_label>
    <description>30 consecutive patients with cardiac FDG PET prescribed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled,&#xD;
        compared to a group with the last 30 patients referred for cardiac FDG PET.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an FDG PET/CT prescribed to explore cardiac disease process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  renal insufficiency,&#xD;
&#xD;
          -  uncompensated diabetes mellitus,&#xD;
&#xD;
          -  pancreatitis,&#xD;
&#xD;
          -  liver insufficiency,&#xD;
&#xD;
          -  hypothyroidism&#xD;
&#xD;
          -  metabolic disorders&#xD;
&#xD;
          -  sepsis.&#xD;
&#xD;
          -  soy protein allergy&#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 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>November 6, 2020</last_update_submitted>
  <last_update_submitted_qc>November 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 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>Myocarditis</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/NCT04437927
org study id: 20-11
nct id: NCT04437927
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is increasing evidence that [18F]-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT is useful
      in the identification and treatment of disease processes that involve cardiac inflammation
      and infection. Current applications include imaging intra-cardiac device and prosthetic valve
      infections, evaluating patients with known or suspected cardiac sarcoidosis or other
      inflammatory cardiomyopathies.

      However, because normal myocardium can metabolize both glucose and free fatty acids (FFAs),
      physiological accumulation of FDG in the myocardium can interfere with the recognition of
      abnormal FDG uptake.

      The use of a low-carbohydrate diet with a prolonged fast ≥ 12 h nutrition followed by a fast
      of at least four hours is the effective preparation recommended to suppress physiological
      myocardial FDG uptake.

      However, the rate of suppression of physiological accumulation of FDG with this method in our
      center is only 50%.
Methodology :

      Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled,
      compared to a group with the last 30 patients referred for cardiac FDG PET in the nuclear
      medicine department of the Centre Hospitalier Princesse Grace.

      Procedures :

      Infusion of 100mL lipid emulsion for intravenous two hours before cardiac FDG PET/CT:

        -  Infusion rate will be 20 mL/hour during the initial 10 minutes (3 mL Intralipid)

        -  The dose will be then increased to 40 mL/hour for the next 10 minutes (6 mL Intralipid)

        -  Finally, for the next 50 minutes the dose will be increased to 100 mL/hour (83mL
           Intralipid)
observational model: Case-Control
time perspective: Prospective
measure: Uptake in the heart scoring according to a visual scale
time frame: day 1
description: Score of 0: complete myocardial suppression
Score of 1: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial interpretation but not cardiac valves.
Score of 2: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and mitral or aortic valve interpretations.
Score of 3: incomplete myocardial suppression with increased myocardial FDG uptake hampering myocardial and both mitral and aortic valves interpretations.
arm group label: Prospective patients
description: 30 consecutive patients with cardiac FDG PET prescribed
arm group label: Control
description: 30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace
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: Myocarditis
mesh term: Inflammation