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Coronary Artery DiseasePhase 3NCT01347710

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

A Phase 3 study testing Flurpiridaz F18 and 99mTechnicium (sestamibi or tetrofosmin) in people with Coronary Artery Disease, run by Lantheus Medical Imaging at 81 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Flurpiridaz F18 and 99mTechnicium (sestamibi or tetrofosmin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
795 participants
Where
81 sitesin 4 countries
Study dates
Jun 2011to Sep 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.

Who cannot join

  • 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.

Trial locations and contacts

81 sites in 4 countries.

81 sites in 4 countries

United States73 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5873

  • Maine Research Associates

    Auburn, Maine, 04210

  • Georgia Health Sciences Univ/Med College of GA

    Augusta, Georgia, 30912

  • Elite Research and Clinical Trials

    Aventura, Florida, 33180

  • Johns Hopkins University

    Baltimore, Maryland, 21287-0817

  • West Side Medical Associates of Los Angeles

    Beverly Hills, California, 90211

  • Mass General Hospital (MGH)

    Boston, Massachusetts, 02114

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Independent Imaging, LLC

    Boynton Beach, Florida, 33437

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida

    Clearwater, Florida, 33756

  • Missouri Cardiovascular Specialists, LLP

    Columbia, Missouri, 65201

  • The Ohio State University

    Columbus, Ohio, 43210

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Wayne State University - Harper University Hospital

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Florida Heart Associates

    Fort Myers, Florida, 33907

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0709

  • St. Mary's Healthcare (Trinity Health)

    Grand Rapids, Michigan, 49503

  • Pinnacle Health Cardiovascular Institute/ Associated Cardiologists

    Harrisburg, Pennsylvania, 17110

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Excel Diagnostics and Nuclear Oncology Center

    Houston, Texas, 77042

  • St. Luke's Cardiology Associates

    Jacksonville, Florida, 32216

  • Gateway Cardiology, PC

    Jerseyville, Illinois, 62052

  • Cardiovascular Imaging Technologies (CVIT)

    Kansas City, Missouri, 64111

  • Katy Cardiology

    Katy, Texas, 77493

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660

  • Center for Biomedical Research

    Knoxville, Tennessee, 37909

  • Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.

    Knoxville, Tennessee, 37917

  • The Cardiovascular Center, PA

    Lake Mary, Florida, 32746

  • Las Vegas Radiology

    Las Vegas, Nevada, 89128

  • USC PET Imaging Science Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • VA West Los Angeles Medical Center

    Los Angeles, California, 90073

  • UCLA

    Los Angeles, California, 90095

  • Norton Cardiovascular Associates

    Louisville, Kentucky, 40205-3372

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama, 36608

  • McLaren Macomb

    Mount Clemens, Michigan, 48043

  • Vanderbilt Heart and Vascular Institute

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06519

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Alfieri Cardiology

    Newark, Delaware, 19713

  • Christiana Care Health System

    Newark, Delaware, 19718

  • Florida Hospital/Cardiovascular Institute (Florida Heart Group)

    Orlando, Florida, 32803

  • Veterans Affairs Palo Alto Health Care System

    Palo Alto, California, 94304

  • South Florida Research Solutions

    Pembroke Pines, Florida, 33028

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Presbyterian University Hospital

    Pittsburgh, Pennsylvania, 15213

  • Cardiovascular Consultants Medical Group

    Pleasant Hill, California, 94523

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • McGuire Veteran Affairs Medical Center

    Richmond, Virginia, 23249

  • Carilion Cardiology Clinic

    Roanoke, Virginia, 24014

  • Roanoke Heart Institute

    Roanoke, Virginia, 24014

  • St. Francis Hospital

    Roslyn, New York, 11576

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6769

  • Northern California PET Imaging Center-Palo Alto

    Sacramento, California, 95816

  • VA San Diego Healthcare System

    San Diego, California, 92161

  • UCSF Medical Center

    San Francisco, California, 94107

  • South Coast Imaging Center

    Savannah, Georgia, 31406

  • Scottsdale Medical Imaging, Ltd.

    Scottsdale, Arizona, 85258

  • Biomedical Research Foundation of Northwest Louisiana

    Shreveport, Louisiana, 71133-8050

  • Saint Louis University School of Medicine

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Memorial Hospital of Tampa

    Tampa, Florida, 33609

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • West Houston Area Clinical Trial Consultants, LLC

    Tomball, Texas, 77375

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania, 19610

  • York Hospital /Wellspan Health

    York, Pennsylvania, 17405

Other trials in United States

Canada4 sites

  • University of Western Ontario

    London, Ontario, N6A 5A5

  • KMH Cardiology and Diagnostic and MRI Centres

    Mississauga, Ontario, L5K 2L3

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Finland2 sites

  • Helsinki University Hospital

    Helsinki, 00029 HUS

  • Turku PET Centre

    Turku, FI-20520

Other trials in Finland

Puerto Rico2 sites

  • San Patricio MEDFLIX (San Patricio MRI & CT Center)

    Guaynabo, 00968

  • VA Caribbean Healthcare System

    San Juan, 00921

Other trials in Puerto Rico

About this study

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)

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).

Read the 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).

Being tested
Flurpiridaz F18, 99mTechnicium (sestamibi or tetrofosmin)
Keywords
Coronary Artery Disease., Positron Emission Tomography Myocardial Perfusion Imaging., Single Positron Emission Computed Tomography., Flurpiridaz F18 Injection.
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flurpiridaz F18Drug

    Also called flurpiridaz F 18

    Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis

  • 99mTechnicium (sestamibi or tetrofosmin)Drug

    Also called 99mTc sestamibi or 99mTc Tetrofosmin

    Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis

Study groups in NCT01347710
Study groupRoleWhat they receive
Flurpiridaz F18ExperimentalOpen-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
Receives: Drug: Flurpiridaz F18; Drug: 99mTechnicium (sestamibi or tetrofosmin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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,

    Measured: 60 days

  2. 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

    Measured: 60 days

Secondary outcomes (10)

  1. 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

    Measured: 60 days

  2. 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

    Measured: 60 days

  3. 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

    Measured: 60 days

  4. 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

    Measured: 60 days

  5. 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

    Measured: 60 days

  6. 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

    Measured: 60 days

  7. 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

    Measured: 60 days

  8. 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

    Measured: 60 days

  9. 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

    Measured: 60 days

  10. Diagnostic Certainty in PET MPI and SPECT MPI

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

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJul 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
795 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01347710
Sponsor's protocol ID
BMS747158-301
Status last verified
Aug 2014
First submitted
11 Apr 2011
Last updated
24 Nov 2020
Data monitoring committee
Yes

Publications

  • Lopez DM, Huck DM, Divakaran S, Brown JM, Weber BN, Lemley M, Builoff V, Shanbhag A, Lan Z, Buckley C, Al-Mallah MH, Dorbala S, Blankstein R, Slomka P, Di Carli MF. Utility of 18F-Flurpiridaz PET Relative Flow Reserve in Differentiating Obstructive From Nonobstructive Coronary Artery Disease. Circ Cardiovasc Imaging. 2025 Nov;18(11):e018323. doi: 10.1161/CIRCIMAGING.125.018323. Epub 2025 Oct 9.

    PubMed 41064867

  • Poitrasson-Riviere A, Moody JB, Renaud JM, Hagio T, Arida-Moody L, Buckley CJ, Al-Mallah MH, Nallamothu BK, Weinberg RL, Ficaro EP, Murthy VL. Integrated myocardial flow reserve (iMFR) assessment: optimized PET blood flow quantification for diagnosis of coronary artery disease. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):136-146. doi: 10.1007/s00259-023-06455-2. Epub 2023 Oct 9.

    PubMed 37807004

  • 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.

    PubMed 36401636

  • 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.

    PubMed 32703509

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Flurpiridaz F18 and 99mTechnicium (sestamibi or tetrofosmin) in people with Coronary Artery Disease, run by Lantheus Medical Imaging at 81 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Canada, Finland, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01347710, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.

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Clinical Trial NCT01347710 | AzTrials