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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-004852-19
    Sponsor's Protocol Code Number:PHRC/2006/r/Pr.Marie
    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:2006-12-29
    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 number2006-004852-19
    A.3Full title of the trial
    Analyse en Morpho-TEP au FDG de l'évolutivité des anévrismes abdominaux aortiques non chirurgicaux
    A.4.1Sponsor's protocol code numberPHRC/2006/r/Pr.Marie
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 FLUCIS
    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 Radionuclide generator
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Abdominal aortic aneurysm.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10000054
    E.1.2Term Abdominal aortic aneurysm
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L’objectif principal de cette étude est de déterminer si les captations globale et segmentaire du FDG, qui peuvent être mesurées dans les parois d’AAA non chirurgicaux, sont prédictives des évolutions à 9 mois du diamètre et du volume de l’anévrisme, déterminés de manière globale et segmentaire en angioscanner.
    E.2.2Secondary objectives of the trial
    1. Déterminer si la valeur prédictive de la captation du FDG, telle qu’elle est décrite dans l’objectif principal (prédiction de l’évolution globale et segmentaire du volume anévrismal à 9 mois), s’avère complémentaire des autres paramètres du bilan initial (diamètre et volume de l’AAA, épaisseur et tension pariétales en angioscanner ; données cliniques et biologiques),
    2. Evaluer les déterminants de la captation globale et segmentaire en FDG (diamètre et volume de l’AAA, épaisseur et tension pariétales en angioscanner ; données cliniques et biologiques).
    3.Evaluer les variations de la captation en FDG entre le bilan initial et le bilan de contrôle du 9ème mois, puis déterminer si ces variations s’avèrent corrélées à celles de marqueurs plasmatiques d’inflammation, de protéolyse et de coagulation.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - AAA d’un diamètre maximal au moins égal à 40 mm, ce diamètre étant calculé selon une méthode standardisée décrite plus loin ;
    - absence d’indication immédiate retenue de traitement de l’AAA par une intervention chirurgicale ou par pose d’endoprothèse ;
    - patients d’un âge supérieur à 18 ans (à l’exception des majeurs sous tutelle) ;
    - patients ayant lu et compris la lettre d’information et ayant signé le formulaire de consentement.
    E.4Principal exclusion criteria
    1) Les AAA ne doivent avoir aucune cause spécifique évidente autre que l’athérosclérose, ce qui implique l’exclusion des formes possiblement :
    - post-traumatiques (antécédent de traumatisme abdominal),
    - familiales (antécédents familiaux d’AAA),
    - liées à une maladie infectieuse (signes ou symptômes évocateurs d’une Brucellose ou d’une Salmonellose),
    - liées à une maladie inflammatoire (signes ou symptômes évocateurs d’une maladie de Behçet ou de Takayasu),
    - liées à une maladie du tissu conjonctif (signes ou symptômes évocateurs d’un syndrome de Marfan ou d’une maladie d’Ehlers-Danlos),
    - liées à une dissection ou à une coarctation aortique.
    2) Il ne doit pas y avoir de pathologie susceptible d’engendrer une réaction inflammatoire intercurrente, ce qui implique l’exclusion des patients avec antécédent :
    - d’intervention chirurgicale ou d’accident traumatique (≤ 6 mois),
    - d’accident vasculaire ischémique (infarctus myocardique, accident vasculaire cérébral…) (≤ 3 mois),
    - de maladie infectieuse (≤ 1 mois),
    - de cancer ou de collagénose.
    3) Il ne doit pas y avoir de contre-indication à la réalisation des 2 morpho-TEP ou de l’angioscanner de contrôle :
    - femmes enceintes ou allaitantes,
    - femmes en âge et en état de procréer,
    - patients ayant présenté une complication lors de l’angioscanner initial (réaction immuno-allergique, insuffisance rénale…).
    4) Seront aussi exclus :
    - les patients incapables de comprendre le but de l’étude,
    - les patients incapables de se plier au suivi prévu,
    - les patients mineurs ou majeurs et sous tutelle.
    E.5 End points
    E.5.1Primary end point(s)
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 concerned4
    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
    Réalisation du 2è morpho-TEP au FDG chez les 55 patients inclus.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state65
    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 Decision2006-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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