| Trial ID: | L4067 |
| Source ID: | NCT01648296
|
| Associated Drug: |
[18f]Fluorbetaox
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| Title: |
Fatty Acid Radiotracer Comparison Study in Heart Failure Patients
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01648296/results
|
| Conditions: |
Heart Failure|Obesity|Type 2 Diabetes Mellitus|Health Normal Volunteer Subjects
|
| Interventions: |
DRUG: [18F]FluorbetaOx
|
| Outcome Measures: |
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., The values in the table represent the number of participants, specifically Dosimetry and Kinetic patients and that is how the primary endpoint is arrived at. This is how the primary endpoint is determined through PET/CT measurements of Myocardial FA metabolism with F-18 Florbeta Ox. The data intended for this Outcome Measure use PET/CT images to visualize the amount of myocardial FA metabolism appears with the radio tracer, Florbeta Ox., 24-72 hrs | Secondary: To Determine Human Dosimetry Based on the Human Biodistribution of [18F](+/-)NOS in Both Normal Healthy Volunteers and Dilated Non-ischemic Cardiomyopathy Patients., A total of 0 subjects (Four normal healthy volunteer subjects and0 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy)will receive a single intravenous injection of 10 mCi of\[18F\]FluorbetaOx followed by PET-CT imaging at two separate time points. The difference between primary Outcome and the secondary outcome are the patients themselves. Florbeta Ox was measured in normal healthy volunteers and in non-ischemic cardiomyopathy patients through PET/CT image visualization., 2-3 days post [18F]FluorbetaOx injection
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| Sponsor/Collaborators: |
Sponsor: Washington University School of Medicine
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2012-09-13
|
| Completion Date: |
2014-06-04
|
| Results First Posted: |
2019-11-27
|
| Last Update Posted: |
2020-02-24
|
| Locations: |
Washington University School of Medicine, Saint Louis, Missouri, 63110, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01648296
|
