Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 50 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01648296
The ClinicalTrials.gov registry entry for NCT01648296 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [18F]FluorbetaOx is the first listed.
NCT01648296 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.