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    Summary
    EudraCT Number:2016-002911-16
    Sponsor's Protocol Code Number:na
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-11-03
    Trial 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 number2016-002911-16
    A.3Full title of the trial
    PET/MRI and plaque vulnerability
    A feasibility study of 18F-Flutemetamol in atherosclerosis
    PET/MRI onderzoek naar ‘kwetsbare aderverkalking’: een studie naar 18F-Flutemetamol uptake in aderverkalking
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PET/MRI and plaque vulnerability: Flutemetamol
    PET/MRI onderzoek naar ‘kwetsbare aderverkalking’: Flutemetamol
    A.3.2Name or abbreviated title of the trial where available
    PET/MRI and plaque vulnerability: Flutemetamol
    A.4.1Sponsor's protocol code numberna
    A.5.4Other Identifiers
    Name:ABR nummerNumber:NL58543.068.16
    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 SponsorMaastricht University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStichting de Weijerhorst
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Center
    B.5.2Functional name of contact pointNuclear Medicine dept.
    B.5.3 Address:
    B.5.3.1Street AddressP. Debyelaan 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 HX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310433874746
    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 Yes
    D.2.1.1.1Trade name Vizamyl
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healtcare Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 name18F-Flutemetamol
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Atherosclerosis in the carotids and coronary arteries.
    Atherosclerose in de carotiden en coronairen.
    E.1.1.1Medical condition in easily understood language
    Atherosclerosis in the carotid- and coronary arteries.
    Aderverkalking in de grote halsslagaders en kransslagaders.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To validate 18F-Flutemetamol PET in the evaluation of plaque vulnerability.
    18F-Flutemetamol valideren als PET-tracer voor de evaluatie van 'plaque vulnerability'.
    E.2.2Secondary objectives of the trial
    To explore a possible relation between tracer uptake in the carotids and cognitive symptoms or radiological characteristics of (early) dementia.
    Om een mogelijke relatie tussen traceropname in de carotiden met cognitieve klachten of radiologische afwijkingen suspect voor (beginnende) dementie te exploreren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18 years and older (no maximum age)
    Informed consent by signed informed consent form regarding this study
    Either: Patients, who are scheduled for carotid endarterectomy (CEA)
    Or: Patients who are not scheduled to undergo a CEA, but have experienced a TIA/CVA/amaurosis fugax within the last 14 days and at least a 30% stenosis of the symptomatic carotid artery as based on flow velocities with duplex ultrasonography.
    Leeftijd van 18 jaar of ouder (geen maximum leeftijd)
    Getekend informed consent formulier van de betreffende studie.
    Ofwel: patiënten die gepland staan voor een carotisendarteriëctomie (CEA).
    Ofwel: patiënten die niet gepland zijn voor deze procedure, maar die wel in de afgelopen 14 dagen een TIA/CVA/amaurosis fugax hebben gehad en bij duplex onderzoek een stenose van de symptomatische carotis hadden van tenminste 30%.
    E.4Principal exclusion criteria
    Severe cognitive impairment, neurological deficit or comorbidity causing the study to be too high a burden for the patient or disrupting patient’s co-operation with scan procedures.
    Evident other causality for stroke (cardiac embolus, small vessel disease, carotid dissection or thrombogenic diathesis).
    Pregnant women and nursing mothers.
    Contra-indications for MRI.
    Relative contra-indications for MRI-contrast agent: GFR <30ml/min/1,73m2/Previous allergic reaction to MRI contrast agent.
    Contra-indication Flutemetamol: Hypersensitivity to the active substance or to any of the excipients
    Ernstige cognitieve klachten, neurologische uitval of comorbiditeit, waardoor het onderzoek als té belastend wordt ervaren of waardoor de patiënt onvoldoende mee kan werken.
    Evident andere oorzaak van de beroerte (cardiale emboliebron, 'small vessel disease', dissectie, stollingsstoornis)
    Vrouwen die (mogelijk) zwanger zijn of borstvoeding geven.
    Contra-indications for MRI.
    Relatieve contra-indications for MRI-contrastmiddel: GFR <30ml/min/1,73m2 / Eerdere allergische reactie op MRI-contrastmiddel.
    Contra-indicaties Flutemetamol: Overgevoeligheid voor de actieve stof of hulpstoffen.
    E.5 End points
    E.5.1Primary end point(s)
    Target-to-background-ratio in the symptomatic carotid artery plaque.
    'Target-to-background-ratio' in de symptomatische carotis plaque.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 25 patients.
    Na 25 patiënten.
    E.5.2Secondary end point(s)
    MRI and (when available) histologic measures of plaque vulnerability characteristics.
    Tracer uptake in the coronary arteries
    MRI en (zo mogelijk) histologische maten van 'kwetsbare-plaque-kenmerken'.
    Stapeling van de tracer in de coronairen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 25 patients.
    Na 25 patiënten.
    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 No
    E.6.5Efficacy No
    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 No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state25
    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)
    No
    Nee
    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 Decision2016-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-04
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