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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Flurpiridaz F18
99mTechnicium (sestamibi or tetrofosmin)
Sponsored by
Lantheus Medical Imaging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease., Positron Emission Tomography Myocardial Perfusion Imaging., Single Positron Emission Computed Tomography., Flurpiridaz F18 Injection.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiology Associates of Mobile, Inc.
  • Scottsdale Medical Imaging, Ltd.
  • West Side Medical Associates of Los Angeles
  • USC PET Imaging Science Center
  • Cedars-Sinai Medical Center
  • VA West Los Angeles Medical Center
  • UCLA
  • Veterans Affairs Palo Alto Health Care System
  • Cardiovascular Consultants Medical Group
  • Northern California PET Imaging Center-Palo Alto
  • VA San Diego Healthcare System
  • UCSF Medical Center
  • Yale University
  • Alfieri Cardiology
  • Christiana Care Health System
  • Elite Research and Clinical Trials
  • Independent Imaging, LLC
  • Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida
  • Florida Heart Associates
  • St. Luke's Cardiology Associates
  • The Cardiovascular Center, PA
  • Florida Hospital/Cardiovascular Institute (Florida Heart Group)
  • South Florida Research Solutions
  • Memorial Hospital of Tampa
  • Georgia Health Sciences Univ/Med College of GA
  • South Coast Imaging Center
  • Gateway Cardiology, PC
  • Norton Cardiovascular Associates
  • Biomedical Research Foundation of Northwest Louisiana
  • Maine Research Associates
  • Johns Hopkins University
  • Mass General Hospital (MGH)
  • Boston University Medical Center
  • University of Michigan Health System
  • Wayne State University - Harper University Hospital
  • Henry Ford Hospital
  • St. Mary's Healthcare (Trinity Health)
  • McLaren Macomb
  • William Beaumont Hospital
  • Hattiesburg Clinic
  • Missouri Cardiovascular Specialists, LLP
  • Cardiovascular Imaging Technologies (CVIT)
  • Saint Louis University School of Medicine
  • Washington University School of Medicine
  • Las Vegas Radiology
  • Montefiore Medical Center
  • Mount Sinai Medical Center
  • Columbia University Medical Center
  • St. Francis Hospital
  • University of Cincinnati
  • The Ohio State University
  • OhioHealth Research Institute
  • Kettering Medical Center
  • Pinnacle Health Cardiovascular Institute/ Associated Cardiologists
  • Allegheny General Hospital
  • Presbyterian University Hospital
  • Berks Cardiologists, Ltd.
  • York Hospital /Wellspan Health
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Wellmont CVA Heart Institute
  • Center for Biomedical Research
  • Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.
  • Vanderbilt Heart and Vascular Institute
  • Dallas VA Medical Center
  • University of Texas Medical Branch
  • Excel Diagnostics and Nuclear Oncology Center
  • Katy Cardiology
  • West Houston Area Clinical Trial Consultants, LLC
  • University of Virginia Health System
  • McGuire Veteran Affairs Medical Center
  • Carilion Cardiology Clinic
  • Roanoke Heart Institute
  • University of Western Ontario
  • KMH Cardiology and Diagnostic and MRI Centres
  • University of Ottawa Heart Institute
  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)
  • Helsinki University Hospital
  • Turku PET Centre
  • San Patricio MEDFLIX (San Patricio MRI & CT Center)
  • VA Caribbean Healthcare System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flurpiridaz F18

Arm Description

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

Outcomes

Primary Outcome Measures

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,
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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
Diagnostic Certainty in PET MPI and SPECT MPI
Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule

Full Information

First Posted
April 11, 2011
Last Updated
November 6, 2020
Sponsor
Lantheus Medical Imaging
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1. Study Identification

Unique Protocol Identification Number
NCT01347710
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lantheus Medical Imaging

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease., Positron Emission Tomography Myocardial Perfusion Imaging., Single Positron Emission Computed Tomography., Flurpiridaz F18 Injection.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
795 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flurpiridaz F18
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Flurpiridaz F18
Other Intervention Name(s)
flurpiridaz F 18
Intervention Description
Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
Intervention Type
Drug
Intervention Name(s)
99mTechnicium (sestamibi or tetrofosmin)
Other Intervention Name(s)
99mTc sestamibi or 99mTc Tetrofosmin
Intervention Description
Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis
Primary Outcome Measure Information:
Title
Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
Description
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,
Time Frame
60 days
Title
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
Description
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
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Description
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
Time Frame
60 days
Title
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Description
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
Time Frame
60 days
Title
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
Description
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
Time Frame
60 days
Title
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
Description
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
Time Frame
60 days
Title
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
Description
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
Time Frame
60 days
Title
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
Description
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
Time Frame
60 days
Title
Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good
Description
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
Time Frame
60 days
Title
Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good
Description
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
Time Frame
60 days
Title
Image Quality of Rest and Stress (PET vs SPECT).
Description
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
Time Frame
60 days
Title
Diagnostic Certainty in PET MPI and SPECT MPI
Description
Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule
Time Frame
60 days

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
36401636
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.
Results Reference
derived
PubMed Identifier
32703509
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.
Results Reference
derived

Learn more about this trial

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

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