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An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

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ClinicalTrials.gov Identifier: NCT03354273
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : June 30, 2021
Sponsor:
Collaborator:
Pharmaceutical Product Development, LLC
Information provided by (Responsible Party):
GE Healthcare

Tracking Information
First Submitted Date  ICMJE November 21, 2017
First Posted Date  ICMJE November 27, 2017
Last Update Posted Date June 30, 2021
Actual Study Start Date  ICMJE June 8, 2018
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI in the detection of significant CAD [ Time Frame: 60 days ]
Defined by invasive coronary angiography, in patients with suspected CAD
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI compared with SPECT MPI in the detection of CAD [ Time Frame: 60 days ]
    Defined by invasive coronary angiography, in female subjects
    • All subjects (key secondary endpoint)
    • Female subjects
    • Subjects with body mass index (BMI) ≥30 kg/m2
    • Diabetic subjects
  • Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI compared with SPECT MPI in the detection of CAD [ Time Frame: 60 days ]
    Defined by invasive coronary angiography, in subjects with body mass index (BMI) ≥30 kg/m2
  • Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI compared with SPECT MPI in the detection of CAD [ Time Frame: 60 days ]
    Defined by invasive coronary angiography, in diabetic subjects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
Official Title  ICMJE A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease
Brief Summary This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease (CAD)
Intervention  ICMJE
  • Drug: PET MPI
    Flurpiridaz (18F) Injection. All subjects will receive 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of Flurpiridaz (18F) Injection administered at rest and during stress conditions will not exceed a total of 14 mCi (520 MBq) for an individual subject.
  • Drug: SPECT MPI
    SPECT imaging must use 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study will be administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All patients will undergo SPECT MPI.
  • Drug: Pharmacological stress agents
    Pharmacologic stress agents will be restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration will be through an IV line.
Study Arms  ICMJE Experimental: 1
Flurpiridaz PET MPI (following off-study SPECT MPI)
Interventions:
  • Drug: PET MPI
  • Drug: SPECT MPI
  • Drug: Pharmacological stress agents
Publications * Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2018)
552
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
522
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject is a man or woman ≥18 years of age.
  • The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
  • At the time of enrolment, the subject has been scheduled via written documentation to undergo an ICA for the assessment of CAD.
  • The subject has undergone a clinically indicated SPECT OR the patient is willing to undergo SPECT MPI for the purposes of the clinical study.
  • The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal.
  • The subject is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

  • Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating.
  • Patients who are unable to undergo all of the imaging procedures.
  • Patients who have an established diagnosis of CAD as confirmed by any of the following:

    1. Previous myocardial infarction (MI);
    2. Previous cardiac catheter angiography showing ≥50% stenosis;
    3. Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
  • Patients incapable of undergoing either exercise or pharmacological cardiac stress testing.
  • Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing.
  • Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).
  • Patients scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
  • Patients undergoing evaluation for heart transplantation or with history of heart transplantation.
  • Patients enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aleksandar Sarac +44 (0) 1494 546 138 aleksandar.sarac@ge.com
Contact: Emily Vandenbroucke, PhD +1 (312) 8050489 emily.vandenbroucke@ge.com
Listed Location Countries  ICMJE Canada,   Finland,   France,   Germany,   Netherlands,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03354273
Other Study ID Numbers  ICMJE GE-265-303
2017-005011-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GE Healthcare
Study Sponsor  ICMJE GE Healthcare
Collaborators  ICMJE Pharmaceutical Product Development, LLC
Investigators  ICMJE
Study Director: Francois Tranquart, M.D., Ph.D. General Electric Healthcare Life Sciences
PRS Account GE Healthcare
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP