CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 795 enrolled
Drug / intervention
Flurpiridaz F18 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01347710
NCT01347710Phase 3Completed
CompareCT.gov

A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD)

Lantheus Medical Imaging·interventional·Posted May 4, 2011·Updated Nov 24, 2020

In Brief

A Phase 3 clinical trial evaluating Flurpiridaz F18 and 99mTechnicium (sestamibi or tetrofosmin) for Coronary Artery Disease. Completed, enrolled 795 participants across 81 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesCanada, Finland, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2011
Enrollment StartJun 1, 2011
Primary CompletionJul 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.2 years ago

Interventions

Flurpiridaz F18drug

Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis

99mTechnicium (sestamibi or tetrofosmin)drug

Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis