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

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ClinicalTrials.gov Identifier: NCT01347710
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Flurpiridaz F18 Drug: 99mTechnicium (sestamibi or tetrofosmin) Phase 3

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 795 participants
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 : June 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Flurpiridaz F18
Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
 Drug: Flurpiridaz F18
Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
Other Name: flurpiridaz F 18
Drug: 99mTechnicium (sestamibi or tetrofosmin)
Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis
Other Name: 99mTc sestamibi or 99mTc Tetrofosmin


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity [ Time Frame: 60 days ]
    Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,

  2. Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity [ Time Frame: 60 days ]
    Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard


Secondary Outcome Measures :
  1. Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. [ Time Frame: 60 days ]

    Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI >/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard

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  2. Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. [ Time Frame: 60 days ]
    Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI >/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard

  3. Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). [ Time Frame: 60 days ]
    Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard

  4. Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). [ Time Frame: 60 days ]
    Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard

  5. Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). [ Time Frame: 60 days ]
    Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard

  6. Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). [ Time Frame: 60 days ]
    Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard

  7. Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good [ Time Frame: 60 days ]
    Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard

  8. Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good [ Time Frame: 60 days ]
    Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard

  9. Image Quality of Rest and Stress (PET vs SPECT). [ Time Frame: 60 days ]
    Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor

  10. Diagnostic Certainty in PET MPI and SPECT MPI [ Time Frame: 60 days ]
    Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule


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

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 percutaneous coronary intervention within the past six months. See protocol for additional details.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01347710


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Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Cesare Orlandi, MD Lantheus Medical Imaging
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01347710     History of Changes
Other Study ID Numbers: BMS747158-301
First Posted: May 4, 2011    Key Record Dates
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016
Last Verified: August 2014

Keywords provided by Lantheus Medical Imaging:
Coronary Artery Disease.
Positron Emission Tomography Myocardial Perfusion Imaging.
Single Positron Emission Computed Tomography.
Flurpiridaz F18 Injection.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action