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NCT01347710 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
A Phase 3 study, sponsored by Lantheus Medical Imaging.
- Completed
- Registry status
- Phase 3
- Development phase
- 795
- Enrollment target
NCT01347710: Completed Phase 3 study, sponsored by Lantheus Medical Imaging.
NCT01347710 is a Phase 3 study that has completed, run by Lantheus Medical Imaging. The registered enrollment target is 795 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01347710, a Phase 3 study, has completed, sponsored by Lantheus Medical Imaging.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 795 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).
Primary Outcome
Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,
Interventions
- DRUG Flurpiridaz F18
- DRUG 99mTechnicium (sestamibi or tetrofosmin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 795 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT01347710 record still lists
NCT01347710 is an interventional study that assigns participants to a tested intervention. The registered 795 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Flurpiridaz F18 is the first listed.
NCT01347710 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01347710 about?
NCT01347710 is a clinical study titled "A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.". The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) a...
What is the current status of trial NCT01347710?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 795 participants. The study started on 2011-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01347710?
The interventions under investigation include: Flurpiridaz F18 (DRUG), 99mTechnicium (sestamibi or tetrofosmin) (DRUG).
Who is sponsoring clinical trial NCT01347710?
This trial is sponsored by Lantheus Medical Imaging, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01347710's enrollment target sits among peer trials
795 428th of 2000 higher than 1,572 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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