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    Summary
    EudraCT Number:2019-002716-43
    Sponsor's Protocol Code Number:APJ2015/DOTAMIR-CHEVALIER/VS
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-31
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-002716-43
    A.3Full title of the trial
    Pilot Study evaluating somatostatin receptor's PET imaging to detect inflammatory phases of myocarditis
    Etude pilote d'évaluation de l'imagerie TEP des récépteurs de la somatostatine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of PET for detection of infectious myocarditis
    Evaluation du TEP pour la détection des myocardites infectieuses
    A.3.2Name or abbreviated title of the trial where available
    DOTAMIR
    DOTAMIR
    A.4.1Sponsor's protocol code numberAPJ2015/DOTAMIR-CHEVALIER/VS
    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 SponsorCHRU DE NANCY
    B.1.3.4CountryFrance
    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 supportGRICI EST
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU DE NANCY
    B.5.2Functional name of contact pointHUE ANNE-SOPHIE
    B.5.3 Address:
    B.5.3.1Street AddressDRCI BAT RECHERCHE 5 RUE DU MORVAN
    B.5.3.2Town/ cityVANDOEUVRE LES NANCY
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number+330383153475
    B.5.5Fax number+330383157451
    B.5.6E-maildripromoteur@chru-nancy.fr
    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 SOMAKIT TOC 40 microgrammes
    D.2.1.1.2Name of the Marketing Authorisation holderADVANCED ACCELERATOR APPLICATION
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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
    infectious myocarditis
    myocardite infectieuse
    E.1.1.1Medical condition in easily understood language
    myocarditis in infectious stade
    myocardite en stade inflammatoire
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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 determine whether 68Ga-DOTATOC PET / CT is sensitive enough to identify acute inflammatory myocarditis in a population of patients hospitalized for chest pain and for whom a high probability of myocarditis has already been identified using MRI. The prevalence of the disease will be close to 100% at inclusion for these patients
    Déterminer si la TEP/TDM au 68Ga-DOTATOC est suffisamment sensible pour identifier les myocardites en phase aigüe inflammatoire dans une population de patients hospitalisés pour douleur thoracique et pour lesquels une haute probabilité de myocardite a déjà été identifiée en utilisant l’IRM. La prévalence de la maladie sera proche de 100% à l’inclusion pour ces patients
    E.2.2Secondary objectives of the trial
    1. Evaluate the frequency of forms that may still be inflammatory (possibly subacute or chronic forms), with PET / CT with 68Ga-DOTATOC performed 3 to 5 months after inclusion, when the classic signs of progressiveness and acute inflammation have generally disappeared (CRP, Troponin-I, myocardial edema on MRI).

    2. Analyze the concordance of the results obtained by a blind reading by two senior nuclear doctors.
    1. Evaluer la fréquence des formes pouvant être encore inflammatoires (formes possiblement subaigües ou chroniques), avec la TEP/TDM au 68Ga-DOTATOC réalisée 3 à 5 mois après l’inclusion, lorsque les signes classiques d’évolutivité et d’inflammation aigüe ont généralement disparu (CRP, Troponine-I, œdème myocardique en IRM).

    2. Analyser la concordance des résultats obtenus par une lecture réalisée en aveugle par deux médecins nucléaires séniors.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Major patient having received complete information on the organization of the research and having signed their informed consent.
    - Patient hospitalized for chest pain with positive troponins,
    - Patient with a high probability of acute inflammatory myocarditis on secondary MRI (≥ 2 Lake Louise criteria)
    - Person affiliated with or benefiting from a social security scheme.
    - Patient majeur ayant reçu l’information complète sur l’organisation de la recherche et ayant signé son consentement éclairé.
    - Patient hospitalisé pour douleur thoracique avec troponines positives,
    - Patient ayant une haute probabilité de myocardite aigue inflammatoire sur l’IRM secondairement réalisée (≥ 2 critères de Lake Louise)
    - Personne affiliée à un régime de sécurité sociale ou bénéficiaire d’un tel régime.
    E.4Principal exclusion criteria
    - Patient with history of heart disease
    - Patient with coronary stenosis of more than 50% on coronary angiography or CT
    - Patient with a formal or relative contraindication for performing a PET / CT scan at 68Ga DOTATOC
    - Impossibility of performing a PET scan at 68Ga-DOTATOC (agitated, confused patient ...). Unable to schedule the PET / CT exam at 68Ga-DOTATOC within a maximum of 72 hours after the MRI.
    - Patient currently being treated with corticosteroids prior to the 68Ga-DOTATOC PET / CT examination.
    - Patient treated with a somatostatin analogue.
    - Patient with Cushing's syndrome
    - Pregnant woman, likely to be pregnant or breastfeeding
    - A person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice)
    - A person of full age who is unable to express their consent
    - Person deprived of their liberty by a judicial or administrative decision
    - Person undergoing psychiatric care under Articles L. 3212-1 and L. 3213-1
    - Patient avec antécédent de maladie cardiaque
    - Patient ayant une sténose coronaire de plus de 50% à la coronarographie ou en angioscanner
    - Patient ayant une contre-indication formelle ou relative à la réalisation d’une TEP/TDM au 68Ga DOTATOC
    - Impossibilité de réaliser une TEP au 68Ga-DOTATOC (patient agité, confus...). Impossibilité de programmer l’examen TEP/TDM au 68Ga-DOTATOC dans un délai maximal de 72 heures après l’IRM.
    - Patient actuellement traité par corticostéroïdes précédant l’examen TEP/TDM au 68Ga-DOTATOC.
    - Patient traité par un analogue de la somatostatine.
    - Patient atteint d’un syndrome de Cushing
    - Femme enceinte, susceptible de l’être ou en cours d'allaitement
    - Personne majeure faisant l'objet d'une mesure de protection légale (tutelle, curatelle, sauvegarde de justice)
    - Personne majeure hors d'état d'exprimer son consentement
    - Personne privée de liberté par une décision judiciaire ou administrative
    - Personne faisant l'objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1
    E.5 End points
    E.5.1Primary end point(s)
    Presence of a significant myocardial uptake which will be (i) visual and (ii) quantitative by measurement of the SUV (Standardized Uptake Values), considered to be significant of 68Ga-DOTATOC during the initial assessment. Calculation of the sensitivity.
    Présence d’une captation myocardique significative qui sera (i) visuelle et (ii) quantitative par mesure du SUV (Standardized Uptake Values), considérée comme significative de 68Ga-DOTATOC lors du bilan initial. Calcul de la sensibilité.
    E.5.1.1Timepoint(s) of evaluation of this end point
    upon 36 months
    36 mois
    E.5.2Secondary end point(s)
    1. Frequency of significant myocardial uptake of 68Ga-DOTATOC 3 to 5 months after inclusion.

    2. Matched results of the two readers
    1. Fréquence d’une captation myocardique significative de 68Ga-DOTATOC 3 à 5 mois après l’inclusion.

    2. Résultats appariés des deux lecteurs
    E.5.2.1Timepoint(s) of evaluation of this end point
    upon 36 months
    36 mois
    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 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
    the end of the study is defined by the central imaging review by 2 radiologists. They will review randomly, blindly and independently all imaging
    la fin de l'étude est définie par une relecture centralisée de toutes les images par deux radiologistes séniors, de facon aléatoire, en aveugle et indépendamment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state33
    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
    Aucun
    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 Decision2020-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
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