Fatty Acid Radiotracer Comparison Study in Heart Failure Patients
Condition: Heart Failure; Obesity; Type 2 Diabetes Mellitus; Health Normal Volunteer Subjects
MeSH terms: Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      PET imaging will be broken down into 2 groups of subjects (dosimetry and kinetic dynamic
      imaging/[11C]palmitate comparison) with entry into these groups will occur simultaneously.
      All PET imaging will be performed with a Siemens Biograph 40 PET-CT scanner. All patients
      will undergo routine clinical evaluation as dictated by the treating heart failure
      cardiologist. The results of the PET studies will not be provided to the patient or the
      treating cardiologist unless, in the judgment of the Principal Investigator, the images
      demonstrate an unsuspected abnormality that may warrant further evaluation. Subjects will be
      instructed not to eat after midnight the night before the study. However, patients will be
      instructed to continue their heart failure and diabetic medical regimens. The morning of
      their PET study, subjects will have two intravenous catheters placed. One will be placed in
      each arm for the purpose of administering radioactive tracers ([15O]Water, [11C]Palmitate,
      and [18F]FluorbetaOx), drawing blood samples for safety laboratory analysis. Urine samples
      will be obtained along with an Electrocardiogram (ECG) and vital signs. A follow-up telephone
      contact will be done 2-3 days post imaging study to capture unanticipated and serious adverse
      events (SAEs).
    

Intervention name(s): [18F]FluorbetaOx
Intervention type(s): Drug
Intervention description(s): Fluorine 18-labeled FluorbetaOx
Other intervention name(s): IND #113344
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Heart Failure; Obesity; Type 2 Diabetes Mellitus; Health Normal Volunteer Subjects