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    Summary
    EudraCT Number:2017-004793-34
    Sponsor's Protocol Code Number:P171103J
    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:2018-04-04
    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 number2017-004793-34
    A.3Full title of the trial
    68Ga-DOTATATE PET-CTA imaging for the early detection of progressing coronary atherosclerosis
    Détection précoce d'une athérosclérose coronaire évolutive avec la TEP avec injection de 68Ga-DOTATATE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    68Ga-DOTATATE PET-CTA imaging for the early detection of progressing coronary atherosclerosis
    Détection précoce d'une athérosclérose coronaire évolutive avec la TEP avec injection de 68Ga-DOTATATE
    A.3.2Name or abbreviated title of the trial where available
    IPROGRESS
    IPROGRESS
    A.4.1Sponsor's protocol code numberP171103J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-maildamien.vanhoye@aphp.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 No
    D.2.1.1.1Trade name Netspot
    D.2.1.1.2Name of the Marketing Authorisation holderAAA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameNetSpot
    D.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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
    Patients with coronary atherosclerosis without significant myocardial ischemia
    Patients avec une athérosclérose coronaire sans ischémie myocardique significative.
    E.1.1.1Medical condition in easily understood language
    Patients with coronary atherosclerosis without significant myocardial ischemia
    Patients avec une athérosclérose coronaire sans ischémie myocardique significative.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    The primary objective of this study will be to test the association between the intensity of 68Ga-DOTATATE uptake in coronary plaques quantified with PET at M0 and the absolute progression rate of coronary artery calcium scoring (CACS) measured between the CT acquired at M0 and after 2 years.
    L'objectif primaire de cette étude sera de tester la corrélation entre l'intensité de fixation de 68Ga-DOTATATE dans les plaques coronaires mesurées sur la TEP initiale (M0), et la vitesse de progression du score calcique coronaire mesurée en comparant les valeurs mesurées sur le scanner initial (M0) et celui réalisé 2 ans après l'inclusion (M24)
    E.2.2Secondary objectives of the trial
    1. to identify a threshold for the intensity of 68Ga-DOTATATE-PET (mean TBR) in coronary plaques quantified with PET at M0 associated with a higher probability of clinical coronary events after a 2-year follow-up, defined by the composite of cardiovascular death, acute coronary syndromes and ischemia-driven coronary revascularization at two years.
    1. identifier une valeur seuil d’intensité de 68Ga-DOTATATE (TBR moyen) en TEP dans les plaques coronaires associée à une augmentation de la probabilité d’événements cardiovasculaires (critère combiné): mortalité, syndrome coronarien aigu, revascularisation pour nouvelle ischémie documentée après un suivi de 2 ans.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with a coronary artery calcium score (CACS) measured with a low-dose CT between 100 and 1000 and absence of significant ischemia (≥ 12 % of the myocardium) on myocardial perfusion scintigraphy.
    - Age ≥ 18 years
    - Affiliation to a social security regime
    - Signed informed consent.
    - Patients avec un score artériel coronaire calcique mesuré entre 100 et 1000 et une absence d'ischémie myocardique significative (< 12 % du myocarde) en scintigraphie,
    -Age ?18 ans,
    -Signature du consentement,
    -Affiliation à un régime de sécurité sociale (hors AME).
    E.4Principal exclusion criteria
    - Previous acute coronary syndrome or coronary revascularisation
    - LVEF < 40 %
    - Previous severe adverse reaction to iodinated contrast agent
    - Irregular heart rhythm (chronic atrial fibrillation, numerous extrasystoles)
    - Severe asthma
    - Chronic kidney disease (eGFR < 45 ml/min/1.73 m2)
    - Waldenstrom disease
    - Multiple myeloma
    - Autoimmune / inflammatory disease requiring immunosuppressive treatment.
    - Active cancer.
    - Confirmed or suspected pregnancy
    - Impossibility to stay immobile and maintain the supine position during 30 minutes.
    - Patient deprived of liberty or under legal protection measure
    - Participation to an interventional trial involving the use of radiation during the two years of the study.
    - Participation to an interventional trial with the use of new drugs between the inclusion and one month after injecting 68Ga-DOTATATE (expected time period when SAE might occur in relation to the injection of DOTATATE).
    -Antécédent de syndrome coronarien aigu ou de revascularisation coronaire,
    -FEVG < 40 %,
    -Antécédent d'événements indésirables graves aux agents de contraste iodés,
    -Rythme cardiaque irrégulier (fibrillation auriculaires, nombreuses extra-systoles),
    -Asthme,
    -Clairance rénale < 45 ml/mn,
    Maladie de Waldenstrom,
    -Grossesse
    -Myélome multiple,
    -Maladie auto-immune/ inflammatoire nécessitant des traitements immuno-suppresseurs,
    -Cancer actif,
    -Impossibilité de rester immobile et de maintenir la position allongée durant 30 minutes,
    -Patient privé de sa liberté or sous des mesures légales de protection.
    -Participation à un autre protocole de recherche interventionnelle utilisant des radiations pendant les 2 ans de suivi dans l'étude.
    -Participation à un autre protocole de recherche interventionnelle portant sur une nouvelle molécule depuis l'inclusion jusqu'à un mois après l'injection du 68Ga-DOTATATE.
    E.5 End points
    E.5.1Primary end point(s)
    Maximum TBR will be measured in 2D ROIs drawn around all major epicardial coronary arteries (diameter >2 mm) identified on the coronary CTA and averaged into a mean TBR value per patient.
    The increase in CACS will be measured as the difference between the CACS measured at M0 and 2 years later.
    Critère d'évaluation principal: une valeur globale de TBR sera calculée pour chaque patient comme la moyenne des TBR maximaux mesurés sur la TEP dans des régions d'intérêts 2D placées le long des axes coronaires identifiés par coroscanner.
    L'augmentation du score calcique coronaire (SCC) sera calculée comme la différence entre le score mesuré initialement et deux ans plus tard.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximum TBR will be measured in 2D ROIs drawn around all major epicardial coronary arteries (diameter >2 mm) identified on the coronary CTA and averaged into a mean TBR value per patient.
    The increase in CACS will be measured as the difference between the CACS measured at M0 and 2 years later.
    une valeur globale de TBR sera calculée pour chaque patient comme la moyenne des TBR maximaux mesurés sur la TEP dans des régions d’intérêts 2D placées le long des axes coronaires identifiés par coroscanner.
    L’augmentation du score calcique coronaire (SCC) sera calculée comme la différence entre le score mesuré initialement et deux ans plus tard.
    E.5.2Secondary end point(s)
    to identify a threshold for the intensity of 68Ga-DOTATATE-PET (mean TBR) in coronary plaques quantified with PET at M0 associated with rapid progression of CACS (> 100 HU /year)
    identifier une valeur seuil d’intensité de 68Ga-DOTATATE (TBR moyen) en TEP dans les plaques coronaires associée à une progression rapide du score coronaire calcique (> 100 HU / an).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Maximum TBR will be measured in 2D ROIs drawn around all major epicardial coronary arteries (diameter >2 mm) identified on the coronary CTA and averaged into a mean TBR value per patient.
    The increase in CACS will be measured as the difference between the CACS measured at M0 and 2 years later.
    identifier une valeur seuil d’intensité de 68Ga-DOTATATE (TBR moyen) en TEP dans les plaques coronaires associée à une progression rapide du score coronaire calcique (> 100 HU / an).
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state250
    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 Decision2018-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-10
    P. End of Trial
    P.End of Trial StatusOngoing
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