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NCT01648296 · ClinicalTrials.gov registry record · Early Phase 1
Fatty Acid Radiotracer Comparison Study in Heart Failure Patients
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT01648296: Completed Early Phase 1 study, sponsored by Washington University School of Medicine.
NCT01648296 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 50 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01648296, a Early Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG [18F]FluorbetaOx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-09-13 |
| Est. Completion | 2014-06-04 |
| Phase | Early Phase 1 |
What the finished NCT01648296 record still lists
NCT01648296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which [18F]FluorbetaOx is the first listed.
NCT01648296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01648296 about?
NCT01648296 is a clinical study titled "Fatty Acid Radiotracer Comparison Study in Heart Failure Patients". 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 investig...
What is the current status of trial NCT01648296?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2012-09-13. Estimated completion is 2014-06-04.
What interventions are being tested in trial NCT01648296?
The interventions under investigation include: [18F]FluorbetaOx (DRUG).
Who is sponsoring clinical trial NCT01648296?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01648296's enrollment target sits among peer trials
50 493rd of 2000 higher than 1,468 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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