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

November 6, 2020 updated by: Lantheus Medical Imaging

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

795

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flurpiridaz F18
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
Drug: Flurpiridaz F18
Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
Other Names:
  • flurpiridaz F 18
Drug: 99mTechnicium (sestamibi or tetrofosmin)
Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis
Other Names:
  • 99mTc sestamibi or 99mTc Tetrofosmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
Time Frame: 60 days
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
Time Frame: 60 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Time Frame: 60 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lantheus Medical Imaging

Investigators

  • Study Director: Cesare Orlandi, MD, Lantheus Medical Imaging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMS747158-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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