NCT01681524

Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI

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• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.

Detailed description

The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six hundred and seventy-two 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 MPI analysis

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-02-01
• Completion: 2014-05-01
• First posted: 2012-09-10
• Last updated: 2013-05-30