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).
Brief Title
A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Coronary Artery Disease
Eligibility 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.
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.
Inclusion Criteria
Inclusion Criteria:
Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.
Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.
Gender
All
Gender Based
false
Keywords
Coronary Artery Disease.
Positron Emission Tomography Myocardial Perfusion Imaging.
Single Positron Emission Computed Tomography.
Flurpiridaz F18 Injection.
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01347710
Org Class
Industry
Org Full Name
Lantheus Medical Imaging
Org Study Id
BMS747158-301
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
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,
Outcome Measure
Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
Outcome Time Frame
60 days
Outcome Description
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
Outcome Measure
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
Outcome Time Frame
60 days
Secondary Outcomes
Outcome Description
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
I
I
Outcome Time Frame
60 days
Outcome Measure
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Outcome Description
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
Outcome Time Frame
60 days
Outcome Measure
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Outcome Description
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
Outcome Time Frame
60 days
Outcome Measure
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
Outcome Description
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
Outcome Time Frame
60 days
Outcome Measure
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
Outcome Description
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
Outcome Time Frame
60 days
Outcome Measure
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
Outcome Description
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
Outcome Time Frame
60 days
Outcome Measure
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
Outcome Description
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
Outcome Time Frame
60 days
Outcome Measure
Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good
Outcome Description
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
Outcome Time Frame
60 days
Outcome Measure
Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good
Outcome Description
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
Outcome Time Frame
60 days
Outcome Measure
Image Quality of Rest and Stress (PET vs SPECT).
Outcome Description
Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule
Outcome Time Frame
60 days
Outcome Measure
Diagnostic Certainty in PET MPI and SPECT MPI
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Travin
Investigator Email
mtravin@montefiore.org
Investigator Phone
718-920-5014