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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT01347710
First received: April 11, 2011
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Drug: Flurpiridaz F18
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic performance evaluation of CAD (PETVsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Diagnositic performance evaluation of multivessel disease (PETvsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Detection of CAD in subgroups: pharm stress, females and BMI>/=30. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Image quality of rest and stress (PETvsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Diagnostic certainty evaluation of rest and stress (PETvsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluation of reversible defect size of rest and stress (PETvsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety evaluation of flurpiridaz F 18. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 795
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flurpiridaz F18
Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared toSPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization
Drug: Flurpiridaz F18
Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 PCI within the past six months. See protocol for additional details.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347710

  Hide Study Locations
Locations
United States, Alabama
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Scottsdale Medical Imaging, Ltd.
Scottsdale, Arizona, United States, 85258
United States, California
West Side Medical Associates of Los Angeles
Beverly Hills, California, United States, 90211
UCLA
Los Angeles, California, United States, 90095
USC PET Imaging Science Center
Los Angeles, California, United States, 90033
VA West Los Angeles Medical Center
Los Angeles, California, United States, 90073
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94304
Cardiovascular Consultants Medical Group
Pleasant Hill, California, United States, 94523
Northern California PET Imaging Center-Palo Alto
Sacramento, California, United States, 95816
VA San Diego Healthcare System
San Diego, California, United States, 92161
UCSF Medical Center
San Francisco, California, United States, 94107
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Delaware
Alfieri Cardiology
Newark, Delaware, United States, 19713
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, Florida
Elite Research and Clinical Trials
Aventura, Florida, United States, 33180
Independent Imaging, LLC
Boynton Beach, Florida, United States, 33437
Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida
Clearwater, Florida, United States, 33756
Florida Heart Associates
Fort Myers, Florida, United States, 33907
St. Luke's Cardiology Associates
Jacksonville, Florida, United States, 32216
The Cardiovascular Center, PA
Lake Mary, Florida, United States, 32746
Florida Hospital/Cardiovascular Institute (Florida Heart Group)
Orlando, Florida, United States, 32803
South Florida Research Solutions
Pembroke Pines, Florida, United States, 33028
Memorial Hospital of Tampa
Tampa, Florida, United States, 33609
United States, Georgia
Georgia Health Sciences Univ/Med College of GA
Augusta, Georgia, United States, 30912
South Coast Imaging Center
Savannah, Georgia, United States, 31406
United States, Illinois
Gateway Cardiology, PC
Jerseyville, Illinois, United States, 62052
United States, Kentucky
Norton Cardiovascular Associates
Louisville, Kentucky, United States, 40205-3372
United States, Louisiana
Biomedical Research Foundation of Northwest Louisiana
Shreveport, Louisiana, United States, 71133-8050
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-0817
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Mass General Hospital (MGH)
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-5873
Wayne State University - Harper University Hospital
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
St. Mary's Healthcare (Trinity Health)
Grand Rapids, Michigan, United States, 49503
McLaren Macomb
Mount Clemens, Michigan, United States, 48043
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073-6769
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Missouri Cardiovascular Specialists, LLP
Columbia, Missouri, United States, 65201
Cardiovascular Imaging Technologies (CVIT)
Kansas City, Missouri, United States, 64111
Saint Louis University School of Medicine
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas Radiology
Las Vegas, Nevada, United States, 89128
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
The Ohio State University
Columbus, Ohio, United States, 43210
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Kettering Medical Center
Kettering, Ohio, United States, 45429
United States, Pennsylvania
Pinnacle Health Cardiovascular Institute/ Associated Cardiologists
Harrisburg, Pennsylvania, United States, 17110
Presbyterian University Hospital
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, United States, 19610
York Hospital /Wellspan Health
York, Pennsylvania, United States, 17405
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
Center for Biomedical Research
Knoxville, Tennessee, United States, 37909
Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.
Knoxville, Tennessee, United States, 37917
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0709
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States, 77042
Katy Cardiology
Katy, Texas, United States, 77493
West Houston Area Clinical Trial Consultants, LLC
Tomball, Texas, United States, 77375
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
McGuire Veteran Affairs Medical Center
Richmond, Virginia, United States, 23249
Carilion Cardiology Clinic
Roanoke, Virginia, United States, 24014
Roanoke Heart Institute
Roanoke, Virginia, United States, 24014
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5A5
KMH Cardiology and Diagnostic and MRI Centres
Mississauga, Ontario, Canada, L5K 2L3
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada, J1H 5N4
Finland
Helsinki University Hospital
Helsinki, Finland, 00029 HUS
Turku PET Centre
Turku, Finland, FI-20520
Puerto Rico
San Patricio MEDFLIX (San Patricio MRI & CT Center)
Guaynabo, Puerto Rico, 00968
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Cesare Orlandi, MD Lantheus Medical Imaging
  More Information

No publications provided

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01347710     History of Changes
Other Study ID Numbers: BMS747158-301
Study First Received: April 11, 2011
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Coronary Artery Disease.
Positron Emission Tomography Myocardial Perfusion Imaging.
Single Positron Emission Computed Tomography.
Flurpiridaz F18 Injection.

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014