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

Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose

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%.

Study Overview

• Status: Completed
• Conditions: Myocardial Inflammation; Metabolic Preparation

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Monaco
  • Monaco, Monaco
    • Centre Hospitalier Princesse Grace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake in the heart scoring according to a visual scale	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.	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Princesse Grace

Publications and helpful links

General Publications

• Dietz M, Paulmier B, Berthier F, Civaia F, Mocquot F, Serrano B, Nataf V, Hugonnet F, Faraggi M. An Intravenous 100-mL Lipid Emulsion Infusion Dramatically Improves Myocardial Glucose Metabolism Extinction in Cardiac FDG PET Clinical Practice. Clin Nucl Med. 2021 Jun 1;46(6):e317-e324. doi: 10.1097/RLU.0000000000003556.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Inflammation; Myocarditis
• Other Study ID Numbers: 20-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No