NCT01347710

A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 795 (actual)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Flurpiridaz F18	Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
DRUG	99mTechnicium (sestamibi or tetrofosmin)	Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-07-01
• Completion: 2013-09-01
• First posted: 2011-05-04
• Last updated: 2020-11-24
• Results posted: 2016-04-05

Locations

81 sites across 4 countries: United States, Canada, Finland, Puerto Rico