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NCT01936649 · ClinicalTrials.gov registry record · Phase 4
Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.
A Phase 4 study of Heart Failure (HF) and Ventricular Dysfunction, Left, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 4
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT01936649: Completed Phase 4 study of Heart Failure (HF) and Ventricular Dysfunction, Left, sponsored by GE Healthcare.
NCT01936649 is a Phase 4 study of Heart Failure (HF) and Ventricular Dysfunction, Left that has completed, run by GE Healthcare. The registered enrollment target is 63 participants, below the 157-participant average among 3 other Heart Failure (HF) trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01936649, a Phase 4 study of Heart Failure (HF) and Ventricular Dysfunction, Left, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of the study was to assess the reproducibility of quantitative measurements of myocardial uptake of Iobenguane I 123 on planar and single photon emission computed tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy was assessed based upon the absolute differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days apart.
Primary Outcome
Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval \[CI\]) was used as the measure of test stability.
Conditions Studied
Interventions
- DRUG AdreView (Iobenguane I 123 Injection)
Study Locations (1)
New Jersey
- GE Healthcare - Princeton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
What the finished NCT01936649 record still lists
NCT01936649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 157-participant average among 3 other Heart Failure (HF) trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Heart Failure (HF) appearing as the primary indexed condition, and to 1 intervention - of which AdreView (Iobenguane I 123 Injection) is the first listed.
NCT01936649 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT01936649 about?
NCT01936649 is a clinical study titled "Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.". The aim of the study was to assess the reproducibility of quantitative measurements of myocardial uptake of Iobenguane I 123 on planar and single photon emission computed tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy was assessed based upon the absolute...
What is the current status of trial NCT01936649?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2013-08. Estimated completion is 2014-02.
What conditions does trial NCT01936649 study?
This clinical trial studies the following conditions: Heart Failure (HF), Ventricular Dysfunction, Left.
What interventions are being tested in trial NCT01936649?
The interventions under investigation include: AdreView (Iobenguane I 123 Injection) (DRUG).
Who is sponsoring clinical trial NCT01936649?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01936649 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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