A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
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)
1 other identifier
interventional
795
4 countries
81
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Jun 2011
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
April 5, 2016
CompletedNovember 24, 2020
August 1, 2014
2.1 years
April 11, 2011
January 24, 2016
November 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
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,
60 days
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
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
60 days
Secondary Outcomes (10)
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 Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
60 days
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
60 days
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
60 days
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
60 days
- +5 more secondary outcomes
Study Arms (1)
Flurpiridaz F18
EXPERIMENTALOpen-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
Interventions
Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis
Eligibility Criteria
You may qualify if:
- Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, 36608, United States
Scottsdale Medical Imaging, Ltd.
Scottsdale, Arizona, 85258, United States
West Side Medical Associates of Los Angeles
Beverly Hills, California, 90211, United States
USC PET Imaging Science Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
VA West Los Angeles Medical Center
Los Angeles, California, 90073, United States
UCLA
Los Angeles, California, 90095, United States
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, 94304, United States
Cardiovascular Consultants Medical Group
Pleasant Hill, California, 94523, United States
Northern California PET Imaging Center-Palo Alto
Sacramento, California, 95816, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
UCSF Medical Center
San Francisco, California, 94107, United States
Yale University
New Haven, Connecticut, 06519, United States
Alfieri Cardiology
Newark, Delaware, 19713, United States
Christiana Care Health System
Newark, Delaware, 19718, United States
Elite Research and Clinical Trials
Aventura, Florida, 33180, United States
Independent Imaging, LLC
Boynton Beach, Florida, 33437, United States
Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida
Clearwater, Florida, 33756, United States
Florida Heart Associates
Fort Myers, Florida, 33907, United States
St. Luke's Cardiology Associates
Jacksonville, Florida, 32216, United States
The Cardiovascular Center, PA
Lake Mary, Florida, 32746, United States
Florida Hospital/Cardiovascular Institute (Florida Heart Group)
Orlando, Florida, 32803, United States
South Florida Research Solutions
Pembroke Pines, Florida, 33028, United States
Memorial Hospital of Tampa
Tampa, Florida, 33609, United States
Georgia Health Sciences Univ/Med College of GA
Augusta, Georgia, 30912, United States
South Coast Imaging Center
Savannah, Georgia, 31406, United States
Gateway Cardiology, PC
Jerseyville, Illinois, 62052, United States
Norton Cardiovascular Associates
Louisville, Kentucky, 40205-3372, United States
Biomedical Research Foundation of Northwest Louisiana
Shreveport, Louisiana, 71133-8050, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Johns Hopkins University
Baltimore, Maryland, 21287-0817, United States
Mass General Hospital (MGH)
Boston, Massachusetts, 02114, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-5873, United States
Wayne State University - Harper University Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
St. Mary's Healthcare (Trinity Health)
Grand Rapids, Michigan, 49503, United States
McLaren Macomb
Mount Clemens, Michigan, 48043, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073-6769, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Missouri Cardiovascular Specialists, LLP
Columbia, Missouri, 65201, United States
Cardiovascular Imaging Technologies (CVIT)
Kansas City, Missouri, 64111, United States
Saint Louis University School of Medicine
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Las Vegas Radiology
Las Vegas, Nevada, 89128, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
The Ohio State University
Columbus, Ohio, 43210, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Pinnacle Health Cardiovascular Institute/ Associated Cardiologists
Harrisburg, Pennsylvania, 17110, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Presbyterian University Hospital
Pittsburgh, Pennsylvania, 15213, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, 19610, United States
York Hospital /Wellspan Health
York, Pennsylvania, 17405, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660, United States
Center for Biomedical Research
Knoxville, Tennessee, 37909, United States
Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.
Knoxville, Tennessee, 37917, United States
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37232, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0709, United States
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, 77042, United States
Katy Cardiology
Katy, Texas, 77493, United States
West Houston Area Clinical Trial Consultants, LLC
Tomball, Texas, 77375, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
McGuire Veteran Affairs Medical Center
Richmond, Virginia, 23249, United States
Carilion Cardiology Clinic
Roanoke, Virginia, 24014, United States
Roanoke Heart Institute
Roanoke, Virginia, 24014, United States
University of Western Ontario
London, Ontario, N6A 5A5, Canada
KMH Cardiology and Diagnostic and MRI Centres
Mississauga, Ontario, L5K 2L3, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4, Canada
Helsinki University Hospital
Helsinki, 00029 HUS, Finland
Turku PET Centre
Turku, FI-20520, Finland
San Patricio MEDFLIX (San Patricio MRI & CT Center)
Guaynabo, 00968, Puerto Rico
VA Caribbean Healthcare System
San Juan, 00921, Puerto Rico
Related Publications (4)
Lopez DM, Huck DM, Divakaran S, Brown JM, Weber BN, Lemley M, Builoff V, Shanbhag A, Lan Z, Buckley C, Al-Mallah MH, Dorbala S, Blankstein R, Slomka P, Di Carli MF. Utility of 18F-Flurpiridaz PET Relative Flow Reserve in Differentiating Obstructive From Nonobstructive Coronary Artery Disease. Circ Cardiovasc Imaging. 2025 Nov;18(11):e018323. doi: 10.1161/CIRCIMAGING.125.018323. Epub 2025 Oct 9.
PMID: 41064867DERIVEDPoitrasson-Riviere A, Moody JB, Renaud JM, Hagio T, Arida-Moody L, Buckley CJ, Al-Mallah MH, Nallamothu BK, Weinberg RL, Ficaro EP, Murthy VL. Integrated myocardial flow reserve (iMFR) assessment: optimized PET blood flow quantification for diagnosis of coronary artery disease. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):136-146. doi: 10.1007/s00259-023-06455-2. Epub 2023 Oct 9.
PMID: 37807004DERIVEDHagio T, Moody JB, Poitrasson-Riviere A, Renaud JM, Pierce L, Buckley C, Ficaro EP, Murthy VL. Multi-center, multi-vendor validation of deep learning-based attenuation correction in SPECT MPI: data from the international flurpiridaz-301 trial. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1028-1033. doi: 10.1007/s00259-022-06045-8. Epub 2022 Nov 19.
PMID: 36401636DERIVEDMaddahi J, Lazewatsky J, Udelson JE, Berman DS, Beanlands RSB, Heller GV, Bateman TM, Knuuti J, Orlandi C. Phase-III Clinical Trial of Fluorine-18 Flurpiridaz Positron Emission Tomography for Evaluation of Coronary Artery Disease. J Am Coll Cardiol. 2020 Jul 28;76(4):391-401. doi: 10.1016/j.jacc.2020.05.063.
PMID: 32703509DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- CMO
- Organization
- Lantheus Medical Imaging
Study Officials
- STUDY DIRECTOR
Cesare Orlandi, MD
Lantheus Medical Imaging
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2011
First Posted
May 4, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2013
Study Completion
September 1, 2013
Last Updated
November 24, 2020
Results First Posted
April 5, 2016
Record last verified: 2014-08