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

Myocardial Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437927
• Other study ID #: 20-11
• Status: Completed
• Start date: April 7, 2020
• Est. completion date: November 6, 2020

Study information

• Verified date: June 2020
• Source: Centre Hospitalier Princesse Grace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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%.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Metabolic Preparation
• Myocardial Inflammation
• Myocarditis

Locations

Country	Name	City	State
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Princesse Grace

Country where clinical trial is conducted

Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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