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Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose Metabolism in 18F-FDG PET/CT

Sponsor
Centre Hospitalier Princesse Grace (Other)
Overall Status
Completed
CT.gov ID
NCT04437927
Collaborator
(none)
51
Enrollment
1
Location
7
Actual Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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%.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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)

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    51 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose
    Actual Study Start Date :
    Apr 7, 2020
    Actual Primary Completion Date :
    Nov 6, 2020
    Actual Study Completion Date :
    Nov 6, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Prospective patients

    30 consecutive patients with cardiac FDG PET prescribed
    Control

    30 patients referred for cardiac FDG PET in the nuclear medicine department of the Centre Hospitalier Princesse Grace

    Outcome Measures

    Primary Outcome Measures

    1. Uptake in the heart scoring according to a visual scale [day 1]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with an FDG PET/CT prescribed to explore cardiac disease process
    Exclusion Criteria:

    • renal insufficiency,

    • uncompensated diabetes mellitus,

    • pancreatitis,

    • liver insufficiency,

    • hypothyroidism

    • metabolic disorders

    • sepsis.

    • soy protein allergy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Princesse Grace Monaco Monaco

    Sponsors and Collaborators

    • Centre Hospitalier Princesse Grace

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Princesse Grace
    ClinicalTrials.gov Identifier:
    NCT04437927
    Other Study ID Numbers:
    • 20-11
    First Posted:
    Jun 18, 2020
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocarditis
    Inflammation

    Study Results

    No Results Posted as of Nov 9, 2020