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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347710
• Other study ID #: BMS747158-301
• Status: Completed
• Phase: Phase 3
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 795
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Flurpiridaz F18
Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
• 99mTechnicium (sestamibi or tetrofosmin)
Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis

Locations

Country	Name	City	State
Canada	University of Western Ontario	London	Ontario
Canada	KMH Cardiology and Diagnostic and MRI Centres	Mississauga	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec
Finland	Helsinki University Hospital	Helsinki
Finland	Turku PET Centre	Turku
Puerto Rico	San Patricio MEDFLIX (San Patricio MRI & CT Center)	Guaynabo
Puerto Rico	VA Caribbean Healthcare System	San Juan
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Maine Research Associates	Auburn	Maine
United States	Georgia Health Sciences Univ/Med College of GA	Augusta	Georgia
United States	Elite Research and Clinical Trials	Aventura	Florida
United States	Johns Hopkins University	Baltimore	Maryland
United States	West Side Medical Associates of Los Angeles	Beverly Hills	California
United States	Boston University Medical Center	Boston	Massachusetts
United States	Mass General Hospital (MGH)	Boston	Massachusetts
United States	Independent Imaging, LLC	Boynton Beach	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Cincinnati	Cincinnati	Ohio
United States	Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida	Clearwater	Florida
United States	Missouri Cardiovascular Specialists, LLP	Columbia	Missouri
United States	OhioHealth Research Institute	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Dallas VA Medical Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Wayne State University - Harper University Hospital	Detroit	Michigan
United States	Florida Heart Associates	Fort Myers	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	St. Mary's Healthcare (Trinity Health)	Grand Rapids	Michigan
United States	Pinnacle Health Cardiovascular Institute/ Associated Cardiologists	Harrisburg	Pennsylvania
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Excel Diagnostics and Nuclear Oncology Center	Houston	Texas
United States	St. Luke's Cardiology Associates	Jacksonville	Florida
United States	Gateway Cardiology, PC	Jerseyville	Illinois
United States	Cardiovascular Imaging Technologies (CVIT)	Kansas City	Missouri
United States	Katy Cardiology	Katy	Texas
United States	Kettering Medical Center	Kettering	Ohio
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.	Knoxville	Tennessee
United States	Center for Biomedical Research	Knoxville	Tennessee
United States	The Cardiovascular Center, PA	Lake Mary	Florida
United States	Las Vegas Radiology	Las Vegas	Nevada
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	USC PET Imaging Science Center	Los Angeles	California
United States	VA West Los Angeles Medical Center	Los Angeles	California
United States	Norton Cardiovascular Associates	Louisville	Kentucky
United States	Cardiology Associates of Mobile, Inc.	Mobile	Alabama
United States	McLaren Macomb	Mount Clemens	Michigan
United States	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Alfieri Cardiology	Newark	Delaware
United States	Christiana Care Health System	Newark	Delaware
United States	Florida Hospital/Cardiovascular Institute (Florida Heart Group)	Orlando	Florida
United States	Veterans Affairs Palo Alto Health Care System	Palo Alto	California
United States	South Florida Research Solutions	Pembroke Pines	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Presbyterian University Hospital	Pittsburgh	Pennsylvania
United States	Cardiovascular Consultants Medical Group	Pleasant Hill	California
United States	Rhode Island Hospital	Providence	Rhode Island
United States	McGuire Veteran Affairs Medical Center	Richmond	Virginia
United States	Carilion Cardiology Clinic	Roanoke	Virginia
United States	Roanoke Heart Institute	Roanoke	Virginia
United States	St. Francis Hospital	Roslyn	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Northern California PET Imaging Center-Palo Alto	Sacramento	California
United States	Saint Louis University School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	VA San Diego Healthcare System	San Diego	California
United States	UCSF Medical Center	San Francisco	California
United States	South Coast Imaging Center	Savannah	Georgia
United States	Scottsdale Medical Imaging, Ltd.	Scottsdale	Arizona
United States	Biomedical Research Foundation of Northwest Louisiana	Shreveport	Louisiana
United States	Memorial Hospital of Tampa	Tampa	Florida
United States	West Houston Area Clinical Trial Consultants, LLC	Tomball	Texas
United States	Berks Cardiologists, Ltd.	Wyomissing	Pennsylvania
United States	York Hospital /Wellspan Health	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.	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	60 days
Secondary	Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.	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	60 days
Secondary	Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).	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	60 days
Secondary	Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).	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	60 days
Secondary	Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).	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	60 days
Secondary	Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).	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	60 days
Secondary	Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good	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	60 days
Secondary	Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good	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	60 days
Secondary	Image Quality of Rest and Stress (PET vs SPECT).	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	60 days
Secondary	Diagnostic Certainty in PET MPI and SPECT MPI	Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule	60 days