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

NCT04437927 | Completed

• 1 other identifier: 20-11
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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%.

Conditions

Metabolic Preparation; Myocardial Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with an FDG PET/CT prescribed to explore cardiac disease process

You may not qualify if:

• renal insufficiency,
• uncompensated diabetes mellitus,
• pancreatitis,
• liver insufficiency,
• hypothyroidism
• metabolic disorders
• sepsis.
• soy protein allergy

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace: lead

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, Monaco

Location

Related Publications (1)

• 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.

  PMID: 33630808 DERIVED

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: April 7, 2020
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-06

Locations

MO (1)