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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Flurpiridaz F18


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details Exclusion Criteria: Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control Unstable cardiac status History of coronary artery bypass graft History of PCI within the past six months See protocol for additional details

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flurpiridaz F18<br>Open-label study of a single injection of flurpiridaz F18 for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization | Drug: Flurpiridaz F18<br>* Injection of Flurpiridaz F18 for the purposes of PET MPI analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance evaluation of CAD (PETVsSPECT) |  | 12 months | 
| Diagnositic performance evaluation of multivessel disease (PETvsSPECT) |  | 12 months | 
| Detection of CAD in subgroups: pharm stress, females and BMI>/=30 |  | 12 months | 
| Image quality of rest and stress (PETvsSPECT) |  | 12 months | 
| Diagnostic certainty evaluation of rest and stress (PETvsSPECT) |  | 12 months | 
| Evaluation of reversible defect size of rest and stress (PETvsSPECT) |  | 12 months | 
| Safety evaluation of flurpiridaz F 18 will include monitoring the number participants with adverse events (AEs), medication errors, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs). |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flurpiridaz F18 Injection, Positron Emission Tomography Myocardial Perfusion Imaging, Single Positron Emission Computed Tomography, Coronary Artery Disease, Myocardia Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases