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    Summary
    EudraCT Number:2017-005011-14
    Sponsor's Protocol Code Number:GE-265-303
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-005011-14
    A.3Full title of the trial
    A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (F 18) 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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Flurpiridaz (F 18) Injection for Positron Emission Tomography (PET) imaging for assessment of blood flow to the heart in patients referred for Invasive Coronary Angiography because of suspected ishemic heart disease.
    A.4.1Sponsor's protocol code numberGE-265-303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03354273
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGE Healthcare Ltd. and its Affiliates
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGE Healthcare Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare Ltd.
    B.5.2Functional name of contact pointActing medical Director
    B.5.3 Address:
    B.5.3.1Street AddressNightingales Lane
    B.5.3.2Town/ cityChalfont St Giles
    B.5.3.3Post codeHP8 4SP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441494543543037
    B.5.6E-mailFrancois.Tranquart@ge.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFlurpiridaz (F 18) Injection
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFlurpiridaz F18
    D.3.9.1CAS number 863887-89-2
    D.3.9.2Current sponsor code[18F]GEH200458
    D.3.9.3Other descriptive nameFlurpiridaz F18
    D.3.10 Strength
    D.3.10.1Concentration unit Ci/ml curie(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 9.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Assessment of myocardial perfusion using Positron Emission Tomography (PET) imaging of Flurpiridaz (F 18) Injection in patients with suspected coronary artery disease.
    E.1.1.1Medical condition in easily understood language
    Narrowing of the arteries (blood vessels) that supply blood to the heart muscle. This narrowing may cause pain and may indicate an increased risk of future heart attacks.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10028603
    E.1.2Term Myocardial perfusion scan
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (F 18) Injection PET myocardial perfusion imaging (MPI) in the detection of significant CAD, as defined by invasive coronary angiography (ICA), in patients with suspected CAD.

    E.2.2Secondary objectives of the trial
    • Evaluate the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (F 18) Injection PET MPI compared with that of single photon emission computed tomography (SPECT) MPI in the detection of CAD, as defined by ICA, in the following groups of subjects:
    - All subjects (key secondary endpoint)
    - Female subjects
    - Subjects with body mass index (BMI) ≥30 kg/m2
    - Diabetic subjects
    • Assess the safety of Flurpiridaz (F 18) Injection PET MPI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) The subject is a man or woman ≥18 years of age.
    2) The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed, and is willing to allow the study investigator to make the subject’s medical records available to GE Healthcare (including clinically indicated SPECT studies occurring prior to the signing of the ICF as stipulated in inclusion criteria #4).
    3) At the time of enrolment, the subject has been scheduled via written documentation to undergo an ICA for the assessment of CAD.
    4) The subject has undergone a clinically indicated SPECT which meets all study-specific imaging and stress testing criteria and conforms to local guidelines (such as American Society of Nuclear Cardiology or European Association of Nuclear Medicine), OR the patient is willing to undergo SPECT MPI for the purposes of the clinical study.
    5) The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile (has a documented bilateral tubal ligation and oophorectomy and/or documented hysterectomy [bilateral tubal ligation alone is insufficient]) or is post-menopausal (cessation of menses for more than 1 year); enrolment in the study without a pregnancy test at Screening is allowed for these categories of female patients. For women of childbearing potential, the results of either a urine or serum human chorionic gonadotropin pregnancy test (with the result known on the day of radiopharmaceutical administration) must be negative; these subjects must be practicing appropriate birth control from the time of the screening to 30 days after the radiopharmaceutical administration.
    6) The subject is able and willing to comply with all study procedures as described in the protocol.
    E.4Principal exclusion criteria
    1) Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating.
    2) Patients who are unable to undergo all of the imaging procedures.
    3) Patients who have an established diagnosis of CAD as confirmed by any of the following:
    a. Previous myocardial infarction (MI);
    b. Previous cardiac catheter angiography showing ≥50% stenosis;
    c. Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
    4) Patients incapable of undergoing either exercise or pharmacological cardiac stress testing
    5) 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.
    6) For patients for whom pharmacological stress testing is being considered, the following additional exclusion criteria will apply:
    a. Known hypersensitivity to adenosine, regadenoson, dipyridamole, or aminophylline;
    b. Use of a caffeinated substance, dipyridamole-containing medication, or methylxanthine-containing medication within 12 hours prior to vasodilator administration;
    c. Bronchoconstrictive or bronchospastic disease that in the opinion of the investigator poses a significant safety risk for the patient;
    d. Second- or third-degree atrioventricular block or sinus node dysfunction without functioning artificial pacemaker;
    e. Any additional contraindication to the pharmacological stress agent listed in the product’s package insert/summary of product characteristics (SmPCs).
    7) Patients with unstable cardiovascular condition, including but not limited to:
    a. Unstable angina, acute coronary syndrome within 6 months of enrolment;
    b. Transient ischaemic attack/stroke within 3 months of enrolment;
    c. Significant congenital heart disease;
    d. Uncontrolled hypertension;
    e. Uncontrolled tachyarrhythmia leading to symptoms or haemodynamic compromise.
    8) Documented history of heart failure and/or cardiomyopathy (including nonischaemic cardiomyopathy, hypertrophic obstructive cardiomyopathy, or infiltrative cardiomyopathy).
    9) Primary haemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant.
    10) Patients scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
    11) Patients with screening laboratory findings as follows:
    a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal;
    b. Total bilirubin ≥2.0 mg/dL (34.2 µmol/L);
    c. Serum creatinine ≥3.0 mg/dL (265.2 µmol/L).
    12) Patients who present with any clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who have a life expectancy of <6 months, or for whom study participation may compromise their management; and patients whom the investigator judges to be unsuitable for participation in the study for any reason.
    13) Patients undergoing evaluation for heart transplantation or with history of heart transplantation.
    14) 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 17-day follow-up period of this study.
    15) Patients previously enrolled in this study or any Flurpiridaz (F 18) Injection study.
    E.5 End points
    E.5.1Primary end point(s)
    The sensitivity and specificity of Flurpiridaz (18 F) Injection PET MPI in the detection of significant CAD as defined by cardiac catheterisation (ICA).
    Subjects will be considered to have CAD if QCA reveals ≥50% stenosis of ≥1 major coronary artery or major branch.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three qualified independent readers will perform a blinded assessment of each subject’s PET image pair (rest and stress images) and each subject’s SPECT image pair.
    One blinded reviewer will perform QCA for all ICA images.
    The data used for the image reads are captured within about 30 minutes of drug administration.
    E.5.2Secondary end point(s)
    The diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (F 18) Injection PET MPI compared to
    that of SPECT MPI, when the diagnosis of CAD by ICA is the standard of truth, in the following:
    - All subjects (key secondary endpoint)
    - Female subjects
    - Subjects with BMI ≥30 kg/m2
    - Diabetic subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following Flurpiridaz (18 F) Injection administration and after ICA. Three qualified readers (independent from the study) will perform independ. reads of all MPI images. The PET MPI and SPECT MPI reads will be performed by the same set of readers in cross-over sessions independ. of one another. In each session, PET and SPECT images will be displayed in randomised order, nonsequentially, with PET and SPECT MPI exams corresponding to individual subjects randomly allotted into reading session batches. For each modality, perfusion and gated acquisitions of rest and stress images will be rated for image quality and reviewed. After the results of each individual MPI (PET or SPECT) are locked as “blinded” read. The data used for image reads are captured within about 30 min of drug administration.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    99mTC-based myocardial tracers used for SPECT MPI
    E.8.2.4Number of treatment arms in the trial0
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    Finland
    France
    Germany
    Italy
    Netherlands
    Switzerland
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Study subjects will participate in the study for up to 77 days.
    In all cases SPECT and Flurpiridaz (F 18) PET MPI must be performed within 60 days prior to ICA. All subjects will be followed up for AEs within 2 days following Flurpiridaz (F 18) Injection administration, and for AEs and SAEs at approximately 2 weeks (14 to 17 days) following the last Flurpiridaz (F 18) Injection dose administration and at the time of their ICA.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 390
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 260
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 650
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-31
    P. End of Trial
    P.End of Trial StatusOngoing
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