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    Summary
    EudraCT Number:2015-005384-16
    Sponsor's Protocol Code Number:FLORAMICAR
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-005384-16
    A.3Full title of the trial
    A prospective single-arm, monocentric, phase-II explorative study on evaluation of diagnostic use of the PET tracer (18F)-florbetaben (Neuraceq®) in patient with patient with suspected cardiac amyloidosis
    Studio prospettico, monocentrico esplorativo di fase II a singolo braccio per la valutazione dell'impiego diagnostico del tracciante PET (18F)-Florbetaben (Neuraceq®) in pazienti con sospetta amiloidosi cardiaca.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective single-arm, monocentric study on the possibility to use the PET tracer (18F)-florbetaben (Neuraceq®) in patient with patient with suspected cardiac amyloidosis in order to make diagnosis.
    Studio prospettico, a singolo braccio, monocentrico, sul possibile utilizzo finalizzato all'impiego diagnostico del tracciante PET (18F)-Florbetaben (Neuraceq®) in pazienti con sospetta amiloidosi a livello del cuore.
    A.3.2Name or abbreviated title of the trial where available
    FLORAMICAR
    FLORAMICAR
    A.4.1Sponsor's protocol code numberFLORAMICAR
    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 SponsorFONDAZIONE TOSCANA GABRIELE MONASTERIO
    B.1.3.4CountryItaly
    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 supportFondazione Toscana Gabriele Monasterio
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Toscana Gabriele Monasterio
    B.5.2Functional name of contact pointU.O.C Farmaceutica Ospedaliera
    B.5.3 Address:
    B.5.3.1Street Addressvia aurelia sud
    B.5.3.2Town/ citymassa
    B.5.3.3Post code54100
    B.5.3.4CountryItaly
    B.5.4Telephone number0585493507
    B.5.5Fax number0585493508
    B.5.6E-mailfarmacisti@ftgm.it
    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 NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE
    D.2.1.1.2Name of the Marketing Authorisation holderPIRAMAL IMAGING GMBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameNeuraceq 300 MBq/mL soluzione iniettabile
    D.3.2Product code Neuraceq 300 MBq/mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLORBETABEN
    D.3.9.2Current sponsor codeFLORBETABEN
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Patients with high clinical suspicion of cardiac amyloidosis
    Pazienti con elevato sospetto clinico di amiloidosi cardiaca.
    E.1.1.1Medical condition in easily understood language
    Patients with high clinical suspicion of cardiac amyloidosis
    Pazienti con elevato sospetto clinico di amiloidosi cardiaca.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007509
    E.1.2Term Cardiac amyloidosis
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007509
    E.1.2Term Cardiac amyloidosis
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Establish the affinity of the tracer [18F] -Florbetaben for amyloid deposits in patients with clinican suspition of cardiac amyloidosis AL and ATTR.
    Stabilire l’affinità del tracciante [18F]-Florbetaben per i depositi di amiloide cardiaca in pazienti con elevato sospetto clinico di amiloidosi cardiaca AL ed ATTR.
    E.2.2Secondary objectives of the trial
    - Check the possible correlation between the extent of the tracer uptake and the signs of cardiac involvement assessed on MRI.
    - Evaluate if the PET tracer [18F] -Florbetaben for brain amyloid could also show an uptake in extracranial and extracardiac amyloid depositions.
    - Verificare l’eventuale correlazione esistente fra entità di captazione del radiofarmaco e segni di interessamento cardiaco valutati alla RM.
    - Valutare il potenziale utilizzo del tracciante [18F]-Florbetaben nella valutazione di depositi extracerebrali ed extracardiaci di amiloide.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age>20 years, high clinical suspicion of cardiac amyloidosis based on cardiac examination, biomarkers (Nt-proBNP, HS-TnT, immunoglobulin light chains in serum and urine, plasma protein electrophoresis and serum free light chains), baseline ECG, baseline echocardiography, cardiac MRI, histological evidence of amyloid in periumbelical fat (Congo red stain).
    Età > 20anni, elevato sospetto clinico di amiloidosi cardiaca basata su: visita cardiologica, valutazione bioumorale (dosaggio di Nt-proBNP, HS-TnT, catene leggere delle immunoglobuline sieriche ed urinarie, elettroforesi proteine plasmatiche e free light chains plasmatiche), ECG basale, ecocardiografia basale, RM cardiaca, evidenza istologica di amiloide su biopsia del grasso periombelicale (rosso Congo).
    E.4Principal exclusion criteria
    Pregnancy checked by plasma beta-HCG or breast feeding, known ischemic heart disease, hypertrophic cardiomyopathy, storage diseases or other known causes of left ventricule hypertrophy or pseudohypertrophy, hypersensitivity to the active substance or to any of the excipients of the study drug Neuraceq®, renal failure, liver failure.
    Donne in stato di gravidanza accertato mediante dosaggio plasmatico di beta-HCG o in allattamento, cardiopatia ischemica nota, cardiomiopatia ipertrofica, malattie da accumulo o altre cause note di ipertrofia o pseudoipertrofia VS, ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti del farmaco in studio Neuraceq®, insufficienza renale, insufficienza epatica.
    E.5 End points
    E.5.1Primary end point(s)
    Qualitatively and quantitatively evaluation of the extent of tracer myocardial uptake in patients with cardiac amyloidosis both AL and ATTR.
    1. Valutare qualitativamente e quantitativamente la dinamica e l’entità della captazione miocardica del tracciante in pazienti con elevato sospetto clinico di amiloidosi cardiaca AL ed ATTR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    150 minutes (no follow-up visits are needed; the endpoint evaluation is concomitant with the PET examination).
    150 minuti (lo studio non prevede visite di follow-up; la rilevazione dell'endpoint è contestuale all'esame PET).
    E.5.2Secondary end point(s)
    To establish the correlation between regional uptake of the radiopharmaceutical and regional patterns of LGE derived from MRI and quantify any other tissue uptake of the radiopharmaceutical compatible with the presence of amyloid deposits (systemic amyloidosis).
    Stabilire la correlazione fra captazione regionale del radiofarmaco e pattern regionale di LGE derivato dallo studio RM e quantificare eventuali aree di iperaccumulo del radiofarmaco a livello sistemico compatibili con la presenza di depositi tissutali di amiloide (amiloidosi sistemica).
    E.5.2.1Timepoint(s) of evaluation of this end point
    150 minutes (no follow-up visits are needed; the endpoint evaluation is concomitant with the PET examination).
    150 minuti (lo studio non prevede visite di follow-up; la rilevazione dell'endpoint è contestuale all'esame PET).
    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 Yes
    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 Yes
    E.7.1.3.1Other trial type description
    evaluation of [18F]-Florbetaben cardiac affinity
    Valutazione dell'affinità cardiaca del tracciante [18F]-Florbetaben
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    enrollment and PET examination of the last patient included in the FLORAMICAR study
    arruolamento ed esame PET dell'ultimo paziente incluso nello studio FLORAMICAR
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-06-24. Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    the study does not have any plans for treament after its concluison, because it has a diagnostic aim.
    essendo lo scopo del presente studio di tipo diagnostico, non sono previsti programmi di trattamento una volta conclusa la sperimentazione.
    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 Decision2016-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
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