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    Summary
    EudraCT Number:2020-004627-16
    Sponsor's Protocol Code Number:70233
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-02
    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 ConcernedFinland - Fimea
    A.2EudraCT number2020-004627-16
    A.3Full title of the trial
    Clinical Validation of Quantitative Flutemetamol PET/CT in Cardiac Amyloidosis
    Sydämen transtyretiini-amyloidoosin kvantitatiivien isotooppikuvantaminen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the use of a radioactive dye in the diagnosis of a build-up of protein deposits within the heart
    Radioaktiivisen väriaineen kuvantaminen sydämen proteiinikertymäsairauden toteamisessa
    A.4.1Sponsor's protocol code number70233
    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 SponsorHelsinki University Hospital
    B.1.3.4CountryFinland
    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 supportHelsinki University Hospital
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportSakari Alhopuro foundation
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportGeneral Electric Healthcare
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Hospital
    B.5.2Functional name of contact pointDepartment of Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressPaciuksenkatu 3, building 2
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00290
    B.5.3.4CountryFinland
    B.5.4Telephone number+35846 9211247
    B.5.6E-mailvaltteri.uusitalo@hus.fi
    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.2.1.1.1Trade name Vizamyl
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare AS
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameVizamyl
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    Cardiac amyloidosis
    Sydämen amyloidoosi
    E.1.1.1Medical condition in easily understood language
    Protein accumulation disease of the heart causing "stiff heart syndrome"
    Proteiininen kertymäsairaus sydänlihakseen (amyloidoosi), joka aiheuttaa jäykän sydämen oireyhtymän
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In this study we evaluate the diagnostic use of flutemetamol (Vizamyl) radioactive positron emission tomography (PET) imaging agent in the detection of cardiac amyloid disease. Vizamyl is a derivate of Thioflavin-T which is used for dying amyloid proteins for microscopy. Vizamyl is accepted for clinical use in the imaging of amyloid deposits of the brain
    Tutkimuksessamme arvioimme flutemetamol-merkkiaineen (Vizamyl) tarkuutta sydämen amyloidoosin positroniemissiotomografiakuvantamisessa (PET). Vizamyl on kehitetty mikroskooppiväriaine Tioflaviini-T:n pohjalta, jota on käytetty amyloidisäikeiden värjäämiseen. Vizamyl on aiemmin hyväksytty kliiniseen käyttöön aivojen amyloidisäikeiden toteamisessa PET-kuvantamisella.
    E.2.2Secondary objectives of the trial
    We evaluate the possibility of noninvasive detection of different subclasses of amyloid diseases by PET imaging of signal intensity of Vizamyl
    Pyrimme kajoamattomasti tyypittämään PET-kuvantamisen avulla eri amyloidisairauden alatyyppejä. Erilaiset amyloidiproteiinit oletettavasti kuvautuvat eri tavoin PET-kuvauksessa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Known diagnosis of cardiac amyloidosis or previously excluded cardiac amyloidosis (myocardial biopsy or non-invasive imaging).
    Tiedossa oleva sydänamyloidoosi tai aikaisemmin poissuljettu sydänamyloidoosi (sydänlihaksen biopsia tai kajoamaton kuvantaminen)
    E.4Principal exclusion criteria
    Pregnancy
    Raskaus
    E.5 End points
    E.5.1Primary end point(s)
    Total mortality
    Kokonaiskuolleisuus
    E.5.1.1Timepoint(s) of evaluation of this end point
    1,3 and 5 years
    1,3 ja 5 vuotta
    E.5.2Secondary end point(s)
    New diagnosis of heart failure
    Heart failure hospitalization
    Uusi sydämen vajaatoiminnan diagnoosi
    Hospitalisaatio sydämen vajaatoiminnan vuoksi
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,3 and 5 years
    1,3 ja 5 vuotta
    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 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 Yes
    E.6.13.1Other scope of the trial description
    We collect safety data to demonstrate safety of Vizamyl in cardiac population as this not been systematically reported previously. However, safety of Vizamyl is well established in both clinical use and previous clinical trials including also elderly patients.
    Raportoimme turvallisuusdataa, vaikka Vizamylin turvallisuus on tunnettu sekä kliinisen työn että aikaisempien tutkimusten perusteella. Turvallisuusdataa ei ole kuitenkaan systemaattisesti raportoitu sydänpotilaiden tutkimuspopulaatiossa. Sen raportointu voi jatkossa auttaa kuvantamisindikaation laajentamisessa sydänkuvantamiseen. Pääasiallinen tutkimuslähtökohtamme ja painotuksemme on kuitenkin diagnostinen. Vizamyl-annos ei poikkea tavanomaisesta PET-kuvauksesta. Vain kuvauskohde eroaa.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number 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 concerned2
    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 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
    Last follow-up data collected at 5 year time-point
    Viimeinen seurantadata on kerätty (5 vuoden aikapisteessä)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state43
    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)
    Treatment does not differ from normal treatment of clinical patients.
    Tutkimuspotilaiden hoito ei muutu kuvantamistutkimuksemme vuoksi tavanomaisesta.
    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 Decision2020-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-05
    P. End of Trial
    P.End of Trial StatusOngoing
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