A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: Flurpiridaz F18Drug: 99mTechnicium (sestamibi or tetrofosmin)
- Registration Number
- NCT01347710
- Lead Sponsor
- Lantheus Medical Imaging
- 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).
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 795
Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Flurpiridaz F18 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 Flurpiridaz F18 99mTechnicium (sestamibi or tetrofosmin) 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
- Primary Outcome Measures
Name Time Method Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity 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,
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity 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
Name Time Method Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. 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
IDiagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. 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
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). 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
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). 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
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). 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
Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good 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
Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good 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
Image Quality of Rest and Stress (PET vs SPECT). 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
Diagnostic Certainty in PET MPI and SPECT MPI 60 days Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule
Trial Locations
- Locations (81)
Biomedical Research Foundation of Northwest Louisiana
🇺🇸Shreveport, Louisiana, United States
Scottsdale Medical Imaging, Ltd.
🇺🇸Scottsdale, Arizona, United States
Saint Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Helsinki University Hospital
🇫🇮Helsinki, Finland
VA Caribbean Healthcare System
🇵🇷San Juan, Puerto Rico
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
🇨🇦Sherbrooke, Quebec, Canada
The Ohio State University
🇺🇸Columbus, Ohio, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Excel Diagnostics and Nuclear Oncology Center
🇺🇸Houston, Texas, United States
Las Vegas Radiology
🇺🇸Las Vegas, Nevada, United States
West Side Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
USC PET Imaging Science Center
🇺🇸Los Angeles, California, United States
Northern California PET Imaging Center-Palo Alto
🇺🇸Sacramento, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Alfieri Cardiology
🇺🇸Newark, Delaware, United States
Christiana Care Health System
🇺🇸Newark, Delaware, United States
Norton Cardiovascular Associates
🇺🇸Louisville, Kentucky, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Katy Cardiology
🇺🇸Katy, Texas, United States
McGuire Veteran Affairs Medical Center
🇺🇸Richmond, Virginia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Florida Hospital/Cardiovascular Institute (Florida Heart Group)
🇺🇸Orlando, Florida, United States
Mass General Hospital (MGH)
🇺🇸Boston, Massachusetts, United States
Elite Research and Clinical Trials
🇺🇸Aventura, Florida, United States
Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida
🇺🇸Clearwater, Florida, United States
McLaren Macomb
🇺🇸Mount Clemens, Michigan, United States
Gateway Cardiology, PC
🇺🇸Jerseyville, Illinois, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
KMH Cardiology and Diagnostic and MRI Centres
🇨🇦Mississauga, Ontario, Canada
Veterans Affairs Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Georgia Health Sciences Univ/Med College of GA
🇺🇸Augusta, Georgia, United States
Independent Imaging, LLC
🇺🇸Boynton Beach, Florida, United States
Pinnacle Health Cardiovascular Institute/ Associated Cardiologists
🇺🇸Harrisburg, Pennsylvania, United States
VA West Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
St. Luke's Cardiology Associates
🇺🇸Jacksonville, Florida, United States
Memorial Hospital of Tampa
🇺🇸Tampa, Florida, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
Florida Heart Associates
🇺🇸Fort Myers, Florida, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
University of Western Ontario
🇨🇦London, Ontario, Canada
Columbia University Medical Center
🇺🇸New York, New York, United States
York Hospital /Wellspan Health
🇺🇸York, Pennsylvania, United States
Berks Cardiologists, Ltd.
🇺🇸Wyomissing, Pennsylvania, United States
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Turku PET Centre
🇫🇮Turku, Finland
San Patricio MEDFLIX (San Patricio MRI & CT Center)
🇵🇷Guaynabo, Puerto Rico
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.
🇺🇸Knoxville, Tennessee, United States
St. Mary's Healthcare (Trinity Health)
🇺🇸Grand Rapids, Michigan, United States
Cardiology Associates of Mobile, Inc.
🇺🇸Mobile, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Cardiovascular Consultants Medical Group
🇺🇸Pleasant Hill, California, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Wellmont CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States
Center for Biomedical Research
🇺🇸Knoxville, Tennessee, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
Wayne State University - Harper University Hospital
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Vanderbilt Heart and Vascular Institute
🇺🇸Nashville, Tennessee, United States
Cardiovascular Imaging Technologies (CVIT)
🇺🇸Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
South Coast Imaging Center
🇺🇸Savannah, Georgia, United States
West Houston Area Clinical Trial Consultants, LLC
🇺🇸Tomball, Texas, United States
Carilion Cardiology Clinic
🇺🇸Roanoke, Virginia, United States
Roanoke Heart Institute
🇺🇸Roanoke, Virginia, United States
The Cardiovascular Center, PA
🇺🇸Lake Mary, Florida, United States
South Florida Research Solutions
🇺🇸Pembroke Pines, Florida, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Missouri Cardiovascular Specialists, LLP
🇺🇸Columbia, Missouri, United States
Presbyterian University Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Related News
FDA Approves Flyrcado for PET Myocardial Perfusion Imaging - The Cardiology Advisor
FDA Approves Flyrcado for PET Myocardial Perfusion Imaging - eMPR.com
- Prev
- 1
- Next