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    Summary
    EudraCT Number:2021-006660-25
    Sponsor's Protocol Code Number:2020PI119
    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:2021-12-23
    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 number2021-006660-25
    A.3Full title of the trial
    Early feasibility study of somatostatin receptor (68Ga-DOTATOC) PET imaging for the diagnosis of infectious ENDOcarditis
    Étude précoce de faisabilité de l’imagerie TEP des récepteurs de la somatostatine (68Ga-DOTATOC) pour le diagnostic d'ENDOcardite infectieuse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Somatostatin receptor PET study (68Ga-DOTATOC) for the diagnosis of infectious ENDOcarditis
    Étude TEP des récepteurs de la somatostatine (68Ga-DOTATOC) pour le diagnostic d'ENDOcardite infectieuse
    A.3.2Name or abbreviated title of the trial where available
    DOTENDO
    DOTENDO
    A.4.1Sponsor's protocol code number2020PI119
    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 SponsorCHRU 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 supportCHRU de Nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Nancy
    B.5.2Functional name of contact pointRegulatory Project Manageur
    B.5.3 Address:
    B.5.3.1Street Address5 rue du Morvan
    B.5.3.2Town/ cityVandoeuvre les nancy
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.6E-maila.hue@chru-nancy.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 SOMAKIT TOC 40 microgrammes
    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.3.1Product nameSOMAKIT
    D.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 FLUDESOXYGLUCOSE (18F) CURIUM
    D.2.1.1.2Name of the Marketing Authorisation holderCURIUM
    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.3.1Product nameFLUDESOXYGLUCOSE (18F)
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 GLUCOTEP 150 MBq/mL
    D.2.1.1.2Name of the Marketing Authorisation holderCURIUM
    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.3.1Product nameFLUDESOXYGLUCOSE (18F)
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 GLUSCAN 500
    D.2.1.1.2Name of the Marketing Authorisation holderAAA
    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.3.1Product nameFLUDESOXYGLUCOSE (18F)
    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
    infective endocarditis
    Endocardite infectieuse
    E.1.1.1Medical condition in easily understood language
    infective endocarditis
    Endocardite infectieuse
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000667
    E.1.2Term Acute and subacute infective endocarditis in diseases classified elsewhere
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To visually assess the detectability of cardiac and extracardiac foci in association with infective endocarditis (IE) on native or prosthetic valve by 68Ga-DOTATOC PET/CT
    Évaluer visuellement la détectabilité des foyers cardiaques et extracardiaques en lien avec une endocardite infectieuse (EI) sur valve native ou prothétique par la TEP/TDM au 68Ga-DOTATOC
    E.2.2Secondary objectives of the trial
    1. Quantify the uptake of 68Ga-DOTATOC at the site of infection by measuring the Standard Uptake Value (SUV) and the relationship with blood activity
    2. Compare the results of 68Ga-DOTATOC PET/CT with those of 18F-FDG PET in terms of visual and quantitative analysis on whole body scans.
    3. Compare the results of 68Ga-DOTATOC PET/CT with those of 18F-FDG PET, in terms of visual and quantitative analysis of cardiac step examinations.
    1. Quantifier par la mesure du Standard Uptake Value (SUV) et des rapports avec l’activité sanguine, la captation du 68Ga-DOTATOC au niveau des foyers infectieux
    2. Comparer les résultats apportés par la TEP/TDM au 68Ga-DOTATOC à ceux apportés par la TEP au 18F-FDG, en termes d’analyse visuelle et quantitative sur les examens du corps entier.
    3. Comparer les résultats apportés par la TEP/TDM au 68Ga-DOTATOC à ceux apportés par la TEP au 18F-FDG, en termes d’analyse visuelle et quantitative sur les examens du pas cardiaque.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult having received full information on the organization of the research and having signed informed consent.
    - Participant hospitalized for definite AR according to the modified Duke criteria (Li), on native or prosthetic valve, referred for 18F-FDG PET/CT by the Cardiology and Infectious Diseases departments
    - Personne majeure ayant reçu l’information complète sur l’organisation de la recherche et ayant signé son consentement éclairé.
    - Participant hospitalisé pour EI certaine selon les critères modifiés de Duke (Li), sur valve native ou prothétique, adressé pour une TEP/TDM au 18F-FDG par les services de Cardiologie et de Maladies infectieuses

    E.4Principal exclusion criteria
    - Participant with a formal or relative contraindication to 68Ga DOTATOC PET/CT and/or 18F-FDG PET/CT
    - Impossibility to perform a 68Ga-DOTATOC PET scan (agitated, confused patient...).
    - Inability to schedule 68Ga-DOTATOC PET/CT the day after 18F-FDG PET/CT.
    - Participant treated with a somatostatin analogue.
    - Participant with Cushing's syndrome
    - Pregnant, likely to be pregnant or breastfeeding
    - Participant ayant une contre-indication formelle ou relative à la réalisation d’une TEP/TDM au 68Ga DOTATOC et/ou d’une TEP/TDM au 18F-FDG
    - Impossibilité de réaliser une TEP au 68Ga-DOTATOC (patient agité, confus...).
    - Impossibilité de programmer l’examen TEP/TDM au 68Ga-DOTATOC le lendemain la TEP/TDM au 18F-FDG.
    - Participant traité par un analogue de la somatostatine.
    - Participant atteint d’un syndrome de Cushing
    - Femme enceinte, susceptible de l’être ou en cours d'allaitement
    E.5 End points
    E.5.1Primary end point(s)
    Presence of a visually detectable 68Ga-DOTATOC uptake zone in the cardiac and extra-cardiac foci.
    Présence d’une zone de captation de 68Ga-DOTATOC détectable visuellement au niveau des foyers infectieux cardiaques et extra cardiaques.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At centralized imaging at the end of the study
    Au moment de l'imagerie centralisée à la fin de l'étude
    E.5.2Secondary end point(s)
    1. Quantitative measurement(s) of 68Ga-DOTATOC uptake at the site(s) of infective endocarditis by Standard Uptake Value (SUV) and also by relationships with blood SUVs.
    2. Results of visual and quantitative analysis of 68Ga-DOTATOC PET/CT and 18F-FDG PET scans on whole body examinations.
    3. Results of visual analysis and quantitative analysis of 68Ga-DOTATOC PET/CT and 18F-FDG PET on cardiac step examination.
    1. Mesure(s) quantitative(s) de la fixation de 68Ga-DOTATOC sur le(s) foyer (s) d’endocardite infectieuse par le Standard Uptake Value (SUV) et aussi par des rapports avec les SUV sanguins.
    2. Résultats de l’analyse visuelle et de l’analyse quantitative des TEP/TDM au 68Ga-DOTATOC et des TEP au 18F-FDG sur les examens du corps entier.
    3. Résultats de l’analyse visuelle et de l’analyse quantitative des TEP/TDM au 68Ga-DOTATOC et des TEP au 18F-FDG sur l’examen du pas cardiaque.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At centralized imaging at the end of the study
    Au moment de l'imagerie centralisée à la fin de l'étude
    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 Yes
    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
    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: 15
    F.1.3Elderly (>=65 years) No
    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 state15
    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)
    The study didn't modify the normal treatment condition
    L'étude modifie pas la prise en charge standard du patient
    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 Decision2022-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
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