Early Phase 1
N=28
Fatty Acid Radiotracer Comparison Study in Heart Failure Patients
Heart Failure · Obesity · Type 2 Diabetes Mellitus · Health Normal Volunteer Subjects
Bottom Line
View on ClinicalTrials.gov: NCT01648296 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: The Primary Endpoint is to Determine if PET/CT Measurements of Myocardial FA Metabolism Performed With [18F]FluorbetaOx Correlated With Those Performed With [11C]Palmitate and Calculation of Human Dosimetry.
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- [18F]FluorbetaOx (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint is to Determine if PET/CT Measurements of Myocardial FA Metabolism Performed With [18F]FluorbetaOx Correlated With Those Performed With [11C]Palmitate and Calculation of Human Dosimetry. |
— | — |
| SECONDARY To Determine Human Dosimetry Based on the Human Biodistribution of [18F](+/-)NOS in Both Normal Healthy Volunteers and Dilated Non-ischemic Cardiomyopathy Patients. |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent
- Chronic dilated cardiomyopathy of non-ischemic origin
- New York Heart Association (NYHA)Class II/III heart failure for a minimum of 6 months prior to enrollment
- Heart Failure patients with Left Ventricular Ejection Fracture less than or equal to 35%
- Obesity defined as Body Mass Index of ≥ 30kg/m2
- Type 2 Diabetes Mellitus based on standard American Diabetes Association (ADA) criteria
- Capable of giving informed consent
- Not currently pregnant or nursing: Female subjects must be either: surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of [18F] FluorbetaOx is negative
Exclusion Criteria
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A recent positive pre-study drug/alcohol screen noted in medical records
- Pregnant females as determined by positive (serum or urine) human chorionic gonadotropin(hCG) test at screening or prior to dosing
- Lactating females
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
- History of a psychiatric disorder that will affect the subject's ability to participate in the study
- Restrictive, obstructive, or infiltrative cardiomyopathy; pericardial disease; uncorrected thyroid disease (TSH) noted in medical records
- History of clinically significant coronary artery disease (CAD)including (prior (ST) elevation myocardial infarction, presence of ≥ 50% obstruction of a major coronary artery, and presence of angina)
- Contraindications to PET scanning (i.e., inability to lie flat with arms over head for up to 1½ hours; claustrophobia; current participation in research studies involving radiation exposure such that the total research-related radiation dose to the subject in any given year would exceed the Code of Federal Regulation limits
Data sourced from ClinicalTrials.gov (NCT01648296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.