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    Summary
    EudraCT Number:2022-002585-33
    Sponsor's Protocol Code Number:PETAL
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-002585-33
    A.3Full title of the trial
    A multi-center phase 3 study of 18F-florbetaben positron emission tomography/computed tomography (PET-CT)
    Studio multicentrico di fase 3 sulla diagnosi non invasiva di amiloidosi cardiaca da catene leggere mediante tomografia a emissione di positroni (PET) con 18F florbetaben/tomografia computerizzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center phase 3 study of 18F-florbetaben positron emission tomography/computed tomography
    Studio multicentrico di fase 3 sulla diagnosi non invasiva di amiloidosi cardiaca da catene leggere mediante tomografia a emissione di positroni con 18F florbetaben/tomografia computerizzata
    A.3.2Name or abbreviated title of the trial where available
    PETAL
    PETAL
    A.4.1Sponsor's protocol code numberPETAL
    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 supportLife Molecular Imaging Ldt
    B.4.2CountryUnited Kingdom
    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. Farmacia 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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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
    cardiac amyloidosis
    Amiloidosi cardiaca
    E.1.1.1Medical condition in easily understood language
    cardiac amyloidosis
    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
    To define the positive predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard, in patients with a monoclonal protein
    Definire il valore predittivo positivo della PET/TC con 18F-florbetaben (valutazione visiva) per la diagnosi di AC tipo AL rispetto all’algoritmo diagnostico tradizionale, in pazienti con una componente monoclonale
    E.2.2Secondary objectives of the trial
    To define the diagnostic performance of PET/CT with 18Fflorbetaben (visual evaluation) in terms of sensitivity, specificity, negative predictive value;
    To define cut-offs from myocardial uptake quantification to confirm or discard AL-CA among patients with suspected CA and a monoclonal protein, compared to the standard diagnostic algorithm, from quantitative uptake values;
    To assess the changes in the degree of myocardial 18Fflorbetaben uptake over 12 months in patients with AL-CA;
    To assess the safety and tolerability of PET/CT with 18Fflorbetaben in patients evaluated for suspected CA.
    Definire la performance diagnostica della PET/TC con 18F-florbetaben (valutazione visiva) in termini di sensibilità, specificità, valore predittivo negativo;
    Definire cut-off per la conferma della diagnosi o l’esclusione di AC tipo AL per la diagnosi di AC tipo AL tra i pazienti con sospetto di AC e una componente monoclonale, a partire dai valori di captazione quantitativa;
    Valutare le variazioni nel grado di captazione miocardica di 18F-florbetaben (valutazione quantitativa) nell’arco di 12 mesi nei pazienti con AC tipo AL;
    Valutare la sicurezza e la tollerabilità della PET/TC con 18F-florbetaben in pazienti valutati nel sospetto di AC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women aged >35 years;
    Ability to understand, sign and date the informed consent;
    One or more of the following elements in a clinical setting deemed compatible with CA by expert clinicians: left ventricular hypertrophy (interventricular septum or posterior wall >12 mm on echocardiogram or cardiac magnetic resonance), heart failure symptoms, chronic elevation of troponin above the upper reference limit or BNP >50 ng/L or NT-proBNP >125 ng/L, low QRS
    voltages (particularly when coupled with left ventricular hypertrophy), circumferential subendocardial or diffuse LGE pattern, difficult myocardial nulling, early darkening of the left ventricular cavity, known plasma cell disorder (monoclonal gammopathy of unknown significance, multiple myeloma, extracardiac AL amyloidosis).
    Uomini e donne di età >35 anni;
    Pazienti capaci di comprendere, firmare e datare il consenso informato;
    Uno o più degli elementi seguenti in un contesto clinico ritenuto compatibile con AC da medici esperti: ipertrofia ventricolare sinistra (setto o parete posteriore >12 mm all’ecocardiogramma o alla risonanza magnetica cardiaca); sintomi di scompenso; elevazione cronica della troponina al di sopra del valore di riferimento nella popolazione generale oppure BNP >50 ng/L o NT-proBNP >125 ng/L; bassi voltaggi dei complessi QRS, soprattutto quando associati a ipertrofia miocardica; versamento pleurico o pericardico; pattern LGE subendocardico circonferenziale o diffuso, difficoltà di annullamento del segnale miocardico, “early darkening” della cavità; discrasia plasmacellulare nota (gammopatia monoclonale di significato indeterminato, mieloma multiplo, amiloidosi AL extracardiaca).
    E.4Principal exclusion criteria
    Hypersensitivity to the active principle or any excipient listed in the paragraph 6.1 of the Summary of Product
    Characteristics (RCP) of Neuraceq®;
    Severe chronic kidney disease [estimated glomerular filtration rate <30 mL/min/1,73 m2];
    Liver disease [elevation >2 times above the upper reference limit of AST (normal range: males 34 UI/L, females 30 UI/
    L), ALT (normal range: males 40 UI/L, females 35 UI/L), gamma-GT (normal range: 64 UI/L) or bilirubin (normal range: 1,2 mg/dL)];
    Performing a PET/CT or scintigraphic exam within 24 hours;
    Impossibility to lay flat for about 60 minutes;
    New York Heart Association (NYHA) class IV;
    Pregnancy or breastfeeding, women with childbearing potential and sexually active not employing highly effective contraceptive methods with a low dependency on the user (from the screening to the end of visit 1), which include: i. abstinence, ii. sexual intercourse only with same-sex partners, iii. monogamous relationship with a partner with prior vasectomy, iv. intrauterine device, v. combined hormonal contraception including estrogens and progesteron-like hormones plus the inhibition of ovulation (oral, intravaginal or transdermal), vi. hormonal contraception based on progesterone-like compounds plus the inhibition of ovulation (oral, injectable, implantable), viii. intrauterine device with hormone release. The highly effective contraceptive measures above are not required for women made sterile by surgical means (for example through tube ligation, hysterectomy,
    bilateral salpingectomy, bilateral ovariectomy) or after the menopause, defined as 12 months of spontaneous amenorrhea without another clinical cause and with elevated FSH levels in agreement with the expected values for the menopause. For patients with true abstinence or with just same-sex partners, contraception is not required, as far as this is in line with their preferred and habitual lifestyle. Periodical abstinence (for example, estimate of the timing of ovulation or assessment of body temperature) and coitus interruptus are not acceptable contraceptive methods. If a patient stops to be abstinent, she must use the highly effective contraceptive methods above. The pregnancy status in women potentially fertile will be checked through the measurement of beta human gonadotropin on the serum and repeated at the end of the study;
    Participation to a study involving the administration of an experimental drug within 30 days from the screening or 5 half-lives of the study drug, whichever the longest;
    Lack of informed consent or impossibility to complete study procedures.
    Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti elencati al paragrafo 6.1 del Riassunto delle Caratteristiche del Prodotto (RCP) di Neuraceq®;
    Insufficienza renale severa [GFR stimato < 30 mL/min/1,73 m2];
    Insufficienza epatica [elevazione >2 volte il limite massimo di normalità di AST (range normalità: maschi <34 UI/L, femmine <30 UI/L), ALT (range normalità: maschi <40 UI/L, femmine <35 UI/L), gamma-GT (range normalità: <64 UI/L) o bilirubinemia (range
    normalità: <1,2 mg/dl)];
    Esecuzione di un esame PET/CT o scintigrafico nelle 24 ore;
    Impossibilità di mantenere la posizione sdraiata per 60 minuti;
    Classe New York Heart Association (NYHA) IV;
    Stato di gravidanza e allattamento, donne fertili sessualmente attive in assenza di metodi contraccettivi altamente efficaci, con bassa dipendenza dall’utilizzatore, dallo screening fino a un ciclo mestruale dopo l’ultima dose del farmaco in studio, che comprendono: i. Astinenza; ii. Rapporti sessuali solo con persone dello stesso sesso; iii. Relazione monogama con partner vasectomizzato; iv. Dispositivo intrauterino; v. Contraccezione ormonale combinata contenente estrogeni e progestinici associata all’inibizione dell’ovulazione (orale, intravaginale, transdermica); vi. Contraccezione ormonale a base di soli progestinici associata all’inibizione dell’ovulazione (orale, iniettabile, impiantabile); vii. Sistema intrauterino a rilascio di ormoni. Le misure contraccettive altamente efficaci indicate in precedenza non sono previste per le pazienti chirurgicamente sterili (per es. occlusione delle tube, isterectomia, salpingectomia bilaterale, ovariectomia bilaterale) o in postmenopausa definita come 12 mesi di amenorrea spontanea senza una diversa causa clinica e livelli elevati di FSH in accordo all'intervallo previsto per la post-menopausa. Per i pazienti che praticano una vera astinenza o che hanno esclusivamente partner dello stesso
    sesso non è necessario l’uso della contraccezione, a condizione che ciò sia in linea con il loro stile di vita preferito e abituale. L’astinenza periodica (ad es. metodo del calendario, dell’ovulazione, sintotermico o post-ovulazione) e il coito interrotto non sono metodi di contraccezione accettabili. Nel caso in cui tale paziente cessi di praticare l’astinenza, deve utilizzare i metodi contraccettivi come descritto in precedenza. Lo stato di gravidanza in donne potenzialmente fertili sarà verificato mediante dosaggio ematico della gonadotropina corionica umana al momento dello screening e ripetuto a fine studio;
    Partecipazione ad uno studio in cui sia stato somministrato un farmaco sperimentale entro 30 giorni dallo screening o 5 emivite del farmaco in studio a seconda di quale fra i due periodi sia il più lungo;
    Mancata firma del consenso informato o impossibilità di completare le procedure previste dallo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Positive predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard.
    Valore predittivo positivo della PET/TC con 18F-florbetaben (valutazione visiva) per la diagnosi di AC tipo AL rispetto all’algoritmo diagnostico tradizionale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 (The endpoint evaluation is concomitant with the PET/CT examination)
    Alla Visita 1 (la rilevazione dell'endpoint è contestuale all'esame PET/TC)
    E.5.2Secondary end point(s)
    Sensitivity, specificity, negative predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard.; Cut-off of exclusion or diagnostic confirmation of AC type AL from PET / CT with 18F-florbetaben (quantitative analysis) among patients with suspected AC and monoclonal component;; Variation in the intensity of myocardial uptake of 18F-florbetaben over 12 months in relation to clinical and instrumental variables;; safety and tolerability of PET/CT with 18Fflorbetaben in patients in patients with a monoclonal component, assessed in terms of adverse events during the imaging procedure and in the days immediately following.
    Sensibilità, specificità, valore predittivo negativo della PET/TC con 18F-florbetaben (valutazione visiva) per la diagnosi di AC tipo AL, rispetto all’algoritmo diagnostico tradizionale; Cut-off di esclusione o di conferma diagnostica di AC tipo AL dalla PET/TC con 18F-florbetaben (analisi quantitativa) tra i pazienti con sospetto di AC e componente monoclonale;; Variazione nell’intensità della captazione miocardica di 18F-florbetaben nell’arco di 12 mesi in relazione a variabili cliniche e strumentali;; Sicurezza e tollerabilità della PET/TC con 18F-florbetaben in pazienti con una componente monoclonale, valutata in termini di eventi avversi durante la procedura di imaging e nei giorni immediatamente successivi
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 (The endpoint evaluation is concomitant with the PET/CT examination); Visit 1 (The endpoint evaluation is concomitant with the PET/CT examination); Visit 4 (12 months after visit 1); Visit 2 (4 days after first administration of the IMP at visit 1)
    Alla Visita 1 (la rilevazione dell'endpoint è contestuale all'esame PET/TC); Alla Visita 1 (la rilevazione dell'endpoint è contestuale all'esame PET/TC); Visita 4 (12 mesi dopo la visita 1); Visita 2 (4 giorni dopo la prima somministrazione dell'IMP alla visita 1)
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned6
    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 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
    LVLS
    LVLS
    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 months0
    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 months0
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    not applicable
    Non applicabile
    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 Decision2023-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-19
    P. End of Trial
    P.End of Trial StatusOngoing
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