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    Summary
    EudraCT Number:2021-002898-26
    Sponsor's Protocol Code Number:CHBX2020/49
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-27
    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 number2021-002898-26
    A.3Full title of the trial
    Contribution of PET/CT with Gallium 68 citrate (68Ga-PET/CT) for the diagnosis of prosthetic valve infective endocarditis
    Apport de la TEP/TDM au citrate de Gallium 68 (68Ga-TEP/TDM) pour le diagnostic des endocardites infectieuses sur valve prothétique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Contribution of PET/CT with Gallium 68 citrate (68Ga-PET/CT) for the diagnosis of prosthetic valve infective endocarditis
    Apport de la TEP/TDM au citrate de Gallium 68 pour le diagnostic des endocardites infectieuses sur valve prothétique
    A.3.2Name or abbreviated title of the trial where available
    CiGal-EI-TEP
    CiGal-EI-TEP
    A.4.1Sponsor's protocol code numberCHBX2020/49
    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 SponsorCHU DE BORDEAUX
    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 supportCHU de Bordeaux
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE BORDEAUX
    B.5.2Functional name of contact pointResponsable d'Etudes Cliniques
    B.5.3 Address:
    B.5.3.1Street Address12, rue Dubernat
    B.5.3.2Town/ cityTalence cedex
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number05 57 82 11 34+33
    B.5.5Fax number05 56 79 49 26+33
    B.5.6E-maillaetitia.lacaze-buzy@chu-bordeaux.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 Information not present in EudraCT
    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 name[68Ga]Ga-citrate
    D.3.2Product code [68Ga]Ga-citrate
    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
    Prosthetic valve infective endocarditis
    Endocardites infectieuses sur valve prothétique
    E.1.1.1Medical condition in easily understood language
    Prosthetic valve infective endocarditis
    Endocardites infectieuses sur valve prothétique
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    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
    Estimation of sensitivity of PET/CT with Gallium 68 citrate (68Ga-PET/CT) for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve.
    Estimer la sensibilité de la 68Ga-TEP/TDM pour le diagnostic d’endocardite infectieuse sur valve prothétique chez les patients suspects d’endocardite infectieuse sur valve prothétique.
    E.2.2Secondary objectives of the trial
    - Estimation of other diagnostic accuracy parameters of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve.
    - Estimation of the inter-observer reproducibility of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve.
    - Comparaison of the sensitivity and specificity of 68Ga-PET/CT to those of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve.
    - Estimation of the contribution of 68Ga-PET/CT in the extension assessment at the thoraco-abdomino-pelvic level.
    - Estimation of the contribution of 68Ga-PET/CT in the search for the portal of entry.
    - Estimer les autres paramètres d’exactitude diagnostique de la 68Ga-TEP/TDM pour le diagnostic d’endocardite infectieuse sur valve prothétique chez les patients suspects d’endocardite infectieuse sur valve prothétique.
    - Estimer la reproductibilité inter-observateurs de la 68Ga-TEP/TDM pour le diagnostic d’endocardite infectieuse sur valve prothétique chez les patients suspects d’endocardite infectieuse sur valve prothétique.
    - Comparer la sensibilité et la spécificité de la 68Ga-TEP/TDM à celles de la 18FDG-TEP/TDM pour le diagnostic d’endocardite infectieuse sur valve prothétique.
    - Estimer l’apport de la 68Ga-TEP/TDM dans le bilan d’extension à l’étage thoraco-abdomino-pelvien.
    - Estimer l’apport de la 68Ga-TEP/TDM dans la recherche de la porte d’entrée.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patient (over 18 years old);
    - Patient with a prosthetic heart valve;
    - Patient suspected of infective endocarditis (on clinical and/or microbiological and/or imaging data);
    - Patient whose history is discussed in the multidisciplinary meeting dedicated to endocarditis;
    - Patient beneficiary of a social security scheme;
    - Free, informed and written consent signed by the participant and the investigator.
    - Patient âgé de plus de 18 ans.
    - Patient porteur d’une valve cardiaque prothétique.
    - Patient suspect d’endocardite infectieuse (sur des données cliniques et/ou microbiologiques et/ou d’imagerie).
    - Patient présenté en RCP Endocardite au sein des services impliqués
    - Patient affilié ou bénéficiaire d’un régime de sécurité sociale
    - Consentement libre, éclairé et écrit signé par le participant et le médecin investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par la recherche).
    E.4Principal exclusion criteria
    - pregnant or breastfeeding women;
    - women of childbearing potential not using effective contraception;
    - patients referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent);
    - subject in a period of relative exclusion due to another protocol;
    - known contraindication to PET/CT with injection of radiotracers (hypersensitivity to radiopharmaceuticals and/or excipients).
    - Femmes enceintes ou allaitantes;
    - Femmes en capacité de procréer n’utilisant pas de moyen de contraception efficace;
    - Patients visés aux articles L.1121-5 à L.1121-8 (personnes privées de liberté par décision judiciaire ou administrative, mineurs, personnes majeures faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer leur consentement);
    - Sujet en période d’exclusion relative par rapport à un autre protocole;
    - Contre-indication connue aux examens par TEP avec injection de radiotraceurs (hypersensibilité au radiopharmaceutique et/ou aux excipients).
    E.5 End points
    E.5.1Primary end point(s)
    Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve.
    Sensibilité de la 18FDG-TEP/TDM pour le diagnostic d’endocardite infectieuse sur valve prothétique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after baseline
    3 mois après baseline
    E.5.2Secondary end point(s)
    - Specificity, positive and negative predictive values of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve.
    - Cohen’s kappa for inter-observer reproducibility of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve
    - Sensitivity, specificity and positive and negative predictive values of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve.
    - Discrepancies between 68Ga-PET/CT and 18FDG-PET/CT for the evaluation of the spread of infection assessment and the search for the initial portal of pathogen entry.
    - Spécificité, valeurs prédictives positive et négative de la 68Ga-TEP/TDM pour le diagnostic d’endocardite infectieuse sur valve prothétique chez l’ensemble des patients de l’étude.
    - Sensibilité, spécificité, et valeurs prédictives positive et négative de la 18FDG-TEP/TDM pour le diagnostic d’endocardite infectieuse sur valve prothétique chez l’ensemble des patients de l’étude.
    - Nature des discordances entre les deux imageries diagnostiques.
    - Reproductibilité inter-observateurs de la 68Ga-TEP/TDM pour le diagnostic d’endocardite infectieuse sur valve prothétique, estimée par le coefficient Kappa de Cohen
    - Discordances entre les deux imageries diagnostiques dans le bilan d’extension à l’étage thoraco-abdomino-pelvien.
    - Discordance entre les deux imageries diagnostiques dans la recherche de la porte d’entrée.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months after baseline
    3 mois après baseline
    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 Yes
    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
    LVLP
    DVDP
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state40
    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 Decision2022-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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