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    Summary
    EudraCT Number:2015-002327-26
    Sponsor's Protocol Code Number:69HCL15_0238
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-06
    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 number2015-002327-26
    A.3Full title of the trial
    EVALUATION DES PLAQUES CAROTIDIENNES SYMPTOMATIQUES ET ASYMPTOMATIQUES en IMAGERIE HYBRIDE TEP-IRM AU FLUORURE (18F) DE SODIUM
    EVALUATION DES PLAQUES CAROTIDIENNES SYMPTOMATIQUES ET ASYMPTOMATIQUES en IMAGERIE HYBRIDE TEP-IRM AU FLUORURE (18F) DE SODIUM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION DES PLAQUES CAROTIDIENNES SYMPTOMATIQUES ET ASYMPTOMATIQUES en IMAGERIE HYBRIDE TEP-IRM AU FLUORURE (18F) DE SODIUM
    EVALUATION DES PLAQUES CAROTIDIENNES SYMPTOMATIQUES ET ASYMPTOMATIQUES en IMAGERIE HYBRIDE TEP-IRM AU FLUORURE (18F) DE SODIUM
    A.3.2Name or abbreviated title of the trial where available
    CARTIS
    CARTIS
    A.4.1Sponsor's protocol code number69HCL15_0238
    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 SponsorHospices Civils de Lyon
    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 supportCREATIS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointValérie PLATTNER
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLYON
    B.5.3.4CountryFrance
    B.5.4Telephone number4 72 40 68 40+33
    B.5.5Fax number4 72 11 51 90+33
    B.5.6E-mailvalerie.plattner@chu-lyon.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 Cisnaf 100MBq/kg
    D.2.1.1.2Name of the Marketing Authorisation holderCIS BIO INTERNATIONAL
    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 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
    sujets présentant une sténose carotidienne ≥ à 50% NASCET symptomatique dans les 15 jours précédents (cas) ou asymptomatique (témoins)
    sujets présentant une sténose carotidienne ≥ à 50% NASCET symptomatique dans les 15 jours précédents (cas) ou asymptomatique (témoins)
    E.1.1.1Medical condition in easily understood language
    sujets présentant une sténose carotidienne ≥ à 50% NASCET symptomatique dans les 15 jours précédents (cas) ou asymptomatique (témoins)
    sujets présentant une sténose carotidienne ≥ à 50% NASCET symptomatique dans les 15 jours précédents (cas) ou asymptomatique (témoins)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    Evaluer de façon qualitative et semi-quantitative la fixation du 18F-NaF au niveau des plaques carotidiennes récemment symptomatiques comparé aux plaques carotidiennes asymptomatiques
    Evaluer de façon qualitative et semi-quantitative la fixation du 18F-NaF au niveau des plaques carotidiennes récemment symptomatiques comparé aux plaques carotidiennes asymptomatiques
    E.2.2Secondary objectives of the trial
    - Comparer la fixation du 18F-NaF aux critères morphologiques IRM-HR
    - Comparer la fixation du 18F-NaF aux paramètres de stress hémodynamique au niveau de la paroi artérielle carotidienne.
    - Comparer la fixation du 18F-NaF aux données anatomopathologiques dans le groupe des patients opérés.
    - Evaluer l’association entre fixation du 18F-NaF et marqueurs systémiques de l’inflammation (IL1-Beta, TNF-alpha)
    - Evaluer la charge globale de fixation du 18F-NaF au niveau des plaques d’athérome aux 3 étages (aorte, artères cervicales, artères intracrâniennes +/- coronaires si techniquement possible)
    - Comparer la fixation du 18F-NaF aux critères morphologiques IRM-HR
    - Comparer la fixation du 18F-NaF aux paramètres de stress hémodynamique au niveau de la paroi artérielle carotidienne.
    - Comparer la fixation du 18F-NaF aux données anatomopathologiques dans le groupe des patients opérés.
    - Evaluer l’association entre fixation du 18F-NaF et marqueurs systémiques de l’inflammation (IL1-Beta, TNF-alpha)
    - Evaluer la charge globale de fixation du 18F-NaF au niveau des plaques d’athérome aux 3 étages (aorte, artères cervicales, artères intracrâniennes +/- coronaires si techniquement possible)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cas
    - Age ≥ 18 ans
    - Infarctus cérébral objectivé au scanner ou à l’IRM dans les 15 jours précédents, Absence d’autre cause identifiable d’infarctus cérébral
    - Capacité à donner un consentement éclairé
    Affiliation à un régime de sécurité sociale
    Témoins
    - Age ≥ 18 ans
    - absence de signe clinique en faveur d’un infarctus récent
    - Capacité à donner un consentement éclairé
    - Affiliation à un régime de sécurité sociale
    Cas
    - Age ≥ 18 ans
    - Infarctus cérébral objectivé au scanner ou à l’IRM dans les 15 jours précédents, Absence d’autre cause identifiable d’infarctus cérébral
    - Capacité à donner un consentement éclairé
    Affiliation à un régime de sécurité sociale
    Témoins
    - Age ≥ 18 ans
    - absence de signe clinique en faveur d’un infarctus récent
    - Capacité à donner un consentement éclairé
    - Affiliation à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Score de Rankin modifié ˃ 3
    - Contre-indication à l’IRM : agitation, claustrophobie, pacemaker…
    - Insuffisance rénale (clairance de la créatinine selon Cockroft ˂ 50 ml/min)
    - Grossesse/allaitement
    - Hypersensibilité à la substance active ou aux excipients
    - Score de Rankin modifié ˃ 3
    - Contre-indication à l’IRM : agitation, claustrophobie, pacemaker…
    - Insuffisance rénale (clairance de la créatinine selon Cockroft ˂ 50 ml/min)
    - Grossesse/allaitement
    - Hypersensibilité à la substance active ou aux excipients
    E.5 End points
    E.5.1Primary end point(s)
    Mesure de la SUV (standardized uptake value) et du TBR (tissue-to-background ratio) au niveau des plaques carotidiennes symptomatiques et asymptomatiques
    Mesure de la SUV (standardized uptake value) et du TBR (tissue-to-background ratio) au niveau des plaques carotidiennes symptomatiques et asymptomatiques
    E.5.2Secondary end point(s)
    - analyse IRM à la recherche de facteurs de vulnérabilité : cœur lipidique, hématome intra-plaque, chape fibreuse fine et/ou rompue
    - analyse approfondie de l’environnement hémodynamique
    - à l’aide de modèles mathématiques de dynamique des fluides
    - analyse anatomopathologique du matériel opératoire chez les patients symptomatiques opérés
    - dosage des marqueurs systémiques de l’inflammation (IL1-Beta, TNF-alpha)
    - mesure de la SUV (standardized uptake value) et du TBR (tissue-to-background ratio) au niveau de l’aorte, des artères intracrâniennes et des coronaires
    - analyse IRM à la recherche de facteurs de vulnérabilité : cœur lipidique, hématome intra-plaque, chape fibreuse fine et/ou rompue
    - analyse approfondie de l’environnement hémodynamique
    - à l’aide de modèles mathématiques de dynamique des fluides
    - analyse anatomopathologique du matériel opératoire chez les patients symptomatiques opérés
    - dosage des marqueurs systémiques de l’inflammation (IL1-Beta, TNF-alpha)
    - mesure de la SUV (standardized uptake value) et du TBR (tissue-to-background ratio) au niveau de l’aorte, des artères intracrâniennes et des coronaires
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    sujets présentant une sténose carotidienne ≥ à 50% NASCET Asymptomatique
    sujets présentant une sténose carotidienne ≥ à 50% NASCET Asymptomatique
    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.8.5The 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
    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: 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 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 state12
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-12
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