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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01681524
Recruitment Status : Withdrawn (delayed study start)
First Posted : September 10, 2012
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
Lantheus Medical Imaging

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Flurpiridaz F18 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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)
Study Start Date : November 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Flurpiridaz F18
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
Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Primary Outcome Measures :
  1. Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Diagnostic performance evaluation of CAD (PETVsSPECT) [ Time Frame: 12 months ]
  2. Diagnositic performance evaluation of multivessel disease (PETvsSPECT) [ Time Frame: 12 months ]
  3. Detection of CAD in subgroups: pharm stress, females and BMI>/=30 [ Time Frame: 12 months ]
  4. Image quality of rest and stress (PETvsSPECT) [ Time Frame: 12 months ]
  5. Diagnostic certainty evaluation of rest and stress (PETvsSPECT) [ Time Frame: 12 months ]
  6. Evaluation of reversible defect size of rest and stress (PETvsSPECT) [ Time Frame: 12 months ]
  7. 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). [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01681524

Sponsors and Collaborators
Lantheus Medical Imaging
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Study Director: Cesare Orlandi, MD Lantheus Medical Imaging
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Responsible Party: Lantheus Medical Imaging Identifier: NCT01681524    
Other Study ID Numbers: BMS747158-302
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: April 2013
Keywords provided by Lantheus Medical Imaging:
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
Arterial Occlusive Diseases
Vascular Diseases
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases