Fatty Acid Radiotracer Comparison Study in Heart Failure Patients
Raktažodžiai
Santrauka
apibūdinimas
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).
Datos
| Paskutinį kartą patikrinta: | 01/31/2020 |
| Pirmasis pateikimas: | 07/10/2012 |
| Numatytas registravimas pateiktas: | 07/18/2012 |
| Pirmas paskelbtas: | 07/23/2012 |
| Paskutinis atnaujinimas pateiktas: | 02/20/2020 |
| Paskutinis atnaujinimas paskelbtas: | 02/23/2020 |
| Pirmųjų rezultatų pateikimo data: | 02/05/2018 |
| Pirmojo QC rezultatų pateikimo data: | 11/03/2019 |
| Pirmųjų paskelbtų rezultatų data: | 11/26/2019 |
| Faktinė studijų pradžios data: | 09/12/2012 |
| Numatoma pirminio užbaigimo data: | 06/03/2014 |
| Numatoma studijų užbaigimo data: | 06/03/2014 |
Būklė ar liga
Intervencija / gydymas
Drug: [18F]FluorbetaOx
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Dosimetry Group A total of 12 subjects will receive a single intravenous injection of[18F]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy. | |
| Experimental: Kinetic Dynamic Group A total of 38 subjects will receive a single intravenous injection of [18F]FluorbetaOx, [11C]Palmitate, and [15O]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. 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. [24-72 hrs]
Antrinės rezultatų priemonės
1. To Determine Human Dosimetry Based on the Human Biodistribution of [18F](+/-)NOS in Both Normal Healthy Volunteers and Dilated Non-ischemic Cardiomyopathy Patients. [2-3 days post [18F]FluorbetaOx injection]
