Fatty Acid Radiotracer Comparison Study in Heart Failure Patients
Status:
Completed
Trial end date:
2014-06-04
Target enrollment:
Participant gender:
Summary
A single center, open-label baseline controlled imaging study to designed to assess whether
Positron Emission Tomography (PET) measurements of myocardial Fatty Acid (FA) metabolism
performed with [18F]FluorbetaOx correlates with measurements using [11C]palmitate. This study
involves the investigational use of a PET radioactive tracer, fluorine-18 radiolabeled fatty
acid analog, [18F]FluorbetaOx designed to measure beta oxidation of fatty acids in the
myocardium. The investigators propose to evaluate the feasibility of the method in heart
failure patients with dilated non-ischemic cardiomyopathy (DCM) with or without type-2
diabetes mellitus (T2DM) and obese subjects (Body Mass Index of ≥ 30kg/m2) with or without
T2DM and normal healthy subjects to provide a wide range of perturbations in myocardial FA
metabolism.
Specific objectives include:
1. To assess the diagnostic quality of [18F]FluorbetaOx PET images and kinetics at the
proposed 10 millicurie (mCi) dose.
2. To quantitatively determine the relationship between PET measurements of myocardial FA
metabolism obtained with [18F]FluorbetaOx and those using [11C]Palmitate.
3. To calculate human dosimetry based on the human biodistribution of [18F]FluorbetaOx.
4. Correlate measurements of myocardial FA metabolism with changes in left ventricular
(LV)structure and function performed on a clinically indicated echocardiography at 6-9
months after imaging.