Clinical trial NCT04437927: Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose Metabolism in 18F-FDG PET/CT
Official title: Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Preparation
Myocardial Inflammation
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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%.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Uptake in the heart scoring according to a visual scale
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References:
citation: 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.