Clinical trial NCT01347710: A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease.
Positron Emission Tomography Myocardial Perfusion Imaging.
Single Positron Emission Computed Tomography.
Flurpiridaz F18 Injection.
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 795
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
timeFrame: 60 days
measure: Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
timeFrame: 60 days
Secondary outcomes:
measure: Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
timeFrame: 60 days
measure: Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
timeFrame: 60 days
measure: Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
timeFrame: 60 days
measure: Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
timeFrame: 60 days
measure: Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
timeFrame: 60 days
measure: Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
timeFrame: 60 days
measure: Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good
timeFrame: 60 days
measure: Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good
timeFrame: 60 days
measure: Image Quality of Rest and Stress (PET vs SPECT).
timeFrame: 60 days
measure: Diagnostic Certainty in PET MPI and SPECT MPI
timeFrame: 60 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Cardiology Associates of Mobile, Inc.
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Ltd.
state: Arizona
city: Beverly Hills
country: United States
facility: West Side Medical Associates of Los Angeles
state: California
city: Los Angeles
country: United States
facility: USC PET Imaging Science Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: VA West Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Health Care System
state: California
city: Pleasant Hill
country: United States
facility: Cardiovascular Consultants Medical Group
state: California
city: Sacramento
country: United States
facility: Northern California PET Imaging Center-Palo Alto
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Aventura
country: United States
facility: Elite Research and Clinical Trials
state: Florida
city: Boynton Beach
country: United States
facility: Independent Imaging, LLC
state: Florida
city: Clearwater
country: United States
facility: Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida
state: Florida
city: Fort Myers
country: United States
facility: Florida Heart Associates
state: Florida
city: Jacksonville
country: United States
facility: St. Luke's Cardiology Associates
state: Florida
city: Lake Mary
country: United States
facility: The Cardiovascular Center, PA
state: Florida
city: Orlando
country: United States
facility: Florida Hospital/Cardiovascular Institute (Florida Heart Group)
state: Florida
city: Pembroke Pines
country: United States
facility: South Florida Research Solutions
state: Florida
city: Tampa
country: United States
facility: Memorial Hospital of Tampa
state: Florida
city: Augusta
country: United States
facility: Georgia Health Sciences Univ/Med College of GA
state: Georgia
city: Savannah
country: United States
facility: South Coast Imaging Center
state: Georgia
city: Jerseyville
country: United States
facility: Gateway Cardiology, PC
state: Illinois
city: Louisville
country: United States
facility: Norton Cardiovascular Associates
state: Kentucky
city: Shreveport
country: United States
facility: Biomedical Research Foundation of Northwest Louisiana
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Mass General Hospital (MGH)
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Wayne State University - Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: St. Mary's Healthcare (Trinity Health)
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists, LLP
state: Missouri
city: Kansas City
country: United States
facility: Cardiovascular Imaging Technologies (CVIT)
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Radiology
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health Cardiovascular Institute/ Associated Cardiologists
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Presbyterian University Hospital
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists, Ltd.
state: Pennsylvania
city: York
country: United States
facility: York Hospital /Wellspan Health
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Knoxville
country: United States
facility: Center for Biomedical Research
state: Tennessee
city: Knoxville
country: United States
facility: Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Excel Diagnostics and Nuclear Oncology Center
state: Texas
city: Katy
country: United States
facility: Katy Cardiology
state: Texas
city: Tomball
country: United States
facility: West Houston Area Clinical Trial Consultants, LLC
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Richmond
country: United States
facility: McGuire Veteran Affairs Medical Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Cardiology Clinic
state: Virginia
city: Roanoke
country: United States
facility: Roanoke Heart Institute
state: Virginia
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Mississauga
country: Canada
facility: KMH Cardiology and Diagnostic and MRI Centres
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)
state: Quebec
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: Turku PET Centre
city: Guaynabo
country: Puerto Rico
facility: San Patricio MEDFLIX (San Patricio MRI & CT Center)
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
Study officials:
affiliation: Lantheus Medical Imaging
name: Cesare Orlandi, MD
role: STUDY_DIRECTOR
References:
citation: Hagio 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.
citation: Maddahi 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.