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    Summary
    EudraCT Number:2020-001906-41
    Sponsor's Protocol Code Number:CHUBX2019/24
    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:2021-03-03
    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 number2020-001906-41
    A.3Full title of the trial
    Benefit of positons emission tomography / 68Gallium citrate tomodensitometry for artificial hip and knee chronic infection diagnosis
    Apport de la tomographie par émission de positons / tomodensitométrie au citrate de Gallium 68 (68Ga-TEP/TDM) pour le diagnostic d’infection chronique de prothèse articulaire de hanche ou de genou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Benefit of positons emission tomography / 68Gallium citrate tomodensitometry for artificial hip and knee chronic infection diagnosis
    Apport de la tomographie par émission de positons / tomodensitométrie au citrate de Gallium 68 (68Ga-TEP/TDM) pour le diagnostic d’infection chronique de prothèse articulaire de hanche ou de genou
    A.3.2Name or abbreviated title of the trial where available
    Gal-I-TEP
    Gal-I-TEP
    A.4.1Sponsor's protocol code numberCHUBX2019/24
    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 number057 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 No
    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
    joint prosthesis infection
    infection de prothèse articulaire
    E.1.1.1Medical condition in easily understood language
    joint prosthesis infection
    infection de prothèse articulaire
    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 diagnostic accuracy of 68Ga citrate PET / CT in the diagnosis of chronic hip or knee joint prosthesis infection
    Estimation de l’exactitude diagnostique de la TEP/TDM au citrate de 68Ga dans le diagnostic dans les IPA chroniques de hanche ou de genou
    E.2.2Secondary objectives of the trial
    - Estimation of the inter-observer reproducibility of the PET / CT reading at 68Ga citrate
    - Estimation of the diagnostic accuracy of the multinuclear scintigraphy in the diagnosis in chronic hip or knee joint prosthesis infection.
    - Estimation of the diagnostic accuracy of PET / CT with citrate 68Ga and scintigraphy with polymorphonuclear in the 2 patient subpopulations: knee or hip infection.
    - Comparison of the diagnostic accuracy of PET / CT with 68Ga citrate to that of scintigraphy using polymorphonuclear drugs in the diagnosis of chronic hip or knee joint prosthesis infection.
    - Estimation de la reproductibilité inter-observateurs de la lecture de la TEP/TDM au citrate de 68Ga
    - Estimation de l’exactitude diagnostique de la scintigraphie aux polynucléaires dans le diagnostic dans les IPA chroniques de hanche ou de genou.
    - Estimation de l’exactitude diagnostique de la TEP/TDM au citrate 68Ga et de la scintigraphie aux polynucléaires dans les 2 sous-populations de patients : infection du genou ou de la hanche.
    - Comparaison de l’exactitude diagnostique de la TEP/TDM au citrate de 68Ga à celle de la scintigraphie aux polynucléaires dans le diagnostic dans les IPA chroniques de hanche ou de genou.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged over 18 years old,
    - Patient adressed to reference center for joint prosthesis infection (CRIOA, infectious diseases unit and orthopedic surgery unit) for suspicion of first episode of artificial hip or knee infection.
    - Suspicion of artificial joint infection starting at least one month before evaluation.
    - Patient for who routine diagnosis includes screaning by both bone scintigraphy and polynuclear scintigraphy.
    - Patient with positive bone scintigraphy.
    - Being affiliated to a health insurance system
    - Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)
    - Patient âgé de plus de 18 ans.
    - Patient adressé au centre de référence IOA de l’hôpital Pellegrin (CRIOA, service de maladies infectieuses + service de chirurgie orthopédique) pour suspicion de premier épisode d’infection de prothèse de hanche ou de genou.
    - Suspicion d’IPA évoluant depuis au moins 1 mois lors de l’évaluation.
    - Patient auquel est proposée pour le diagnostic de routine la réalisation d’une exploration couplée : scintigraphie osseuse et scintigraphie aux polynucléaires marqués.
    - Patient avec scintigraphie osseuse positive.
    - Patient affilié ou bénéficiaire d’un régime de sécurité sociale.
    - Consentement libre, éclairé et écrit signé par le participant et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par la recherche).
    E.4Principal exclusion criteria
    - Patient with progressive cancer.
    - Patient with negative bone scintigraphy.
    - Patient who cannot stop antibiotic for 14 days because of his state of health.
    - Pregnant or breastfeeding women.
    - Women of childbearing age but not using effective means of contraception.
    - Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
    - Subject in relative exclusion period from another protocol.
    - Known contraindications to PET exam with radio tracer injection (hypersensitivity to radiopharmaceutical and/or to excipients).
    - Patient atteint d'un cancer actif.
    - Patient avec scintigraphie osseuse négative.
    - Patient dont l’état clinique actuel ne permet pas d’arrêter les antibiotiques 14 jours avant la réalisation de l’examen.
    - Femme enceinte ou allaitante.
    - Femme en âge de procréer n’utilisant pas de moyen de contraception efficace.
    - Patient visé aux articles L 1121-5 à L 1121-8 (personnes privées de liberté par une 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)
    Diagnostic accuracy setting’s assessment of the 68Ga citrate PET/TDM for chronic infection diagnosis of artificial hip or knee (sensibility, specificity, predictive positive and negative value).
    Estimation des paramètres d’exactitude diagnostique de la TEP/TDM au citrate de 68Ga (sensibilité, spécificité, valeurs prédictives positive et négative).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after baseline
    12 mois après l'inclusion
    E.5.2Secondary end point(s)
    - Reproducibility inter- observers of 68Ga citrate PET/TDM interpretation.
    - Diagnostic accuracy setting’s assessment of marked polynuclear scintigraphy.
    - Diagnosis accuracy’s assessment of 68Ga citrate PET/TDM and marked polynuclear scintigraphy for both under-populations: artificial knee or hip infection.
    - Comparison of diagnostic accuracy setting of 68Ga citrate PET/TDM and marked polynuclear scintigraphy.
    - Kind of discrepancy between the two exams.
    - Reproductibilité inter-observateurs de la lecture de la TEP/TDM au citrate de 68Ga.
    - Estimation des paramètres d’exactitude diagnostique de la scintigraphie aux leucocytes marqués.
    - Estimation de l’exactitude diagnostique de la TEP/TDM au citrate 68Ga et de la scintigraphie aux polynucléaires dans les 2 sous-populations de patients : infection du genou ou de la hanche.
    - Comparaison des paramètres d’exactitude diagnostique de la TEP/TDM au citrate de 68Ga à ceux de la scintigraphie aux leucocytes marqués.
    - Nature des discordances entre les 2 imageries diagnostiques.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after baseline
    12 mois après l'inclusion
    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
    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: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 20
    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 state35
    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 Decision2021-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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