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    Summary
    EudraCT Number:2013-003927-12
    Sponsor's Protocol Code Number:CHUBX2012/28
    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:2014-01-21
    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 number2013-003927-12
    A.3Full title of the trial
    Development of an innovative Gallium 68 radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT imaging of neuro-endocrine tumors and preliminary clinical evaluation
    MISE AU POINT D'UN NOUVEAU MARQUAGE DU DOTATOC PAR LE GALLIUM 68 (68GA -DOTATOC) POUR L'IMAGERIE TEP-TDM ET EVALUATION CLINIQUE PRELIMINAIRE DANS LES TUMEURS NEURO-ENDOCRINES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Development of an innovative tracer imaging of neuro-endocrine tumors and preliminary clinical evaluation
    Mise au point d'un nouveau marquage pour l'imagerie et l'évaluation clinique préliminaire dans les tumeurs neuro-endocrine.
    A.3.2Name or abbreviated title of the trial where available
    GALTEP
    GALTEP
    A.4.1Sponsor's protocol code numberCHUBX2012/28
    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 pointLeila Boukami
    B.5.3 Address:
    B.5.3.1Street Address12, rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number0557820317+33
    B.5.5Fax number0556794926+33
    B.5.6E-mailleila.boukami@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 nameDOTATOC marqué au Gallium 68
    D.3.2Product code 68Ga-DOTATOC
    D.3.4Pharmaceutical form Radiopharmaceutical precursor, solution
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    neuroendocrine tumors
    tumeur neuro-endocrines
    E.1.1.1Medical condition in easily understood language
    neuroendocrine tumors
    tumeur neuro-endocrines
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10052399
    E.1.2Term Neuroendocrine tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    validate the radiosynthesis of 68Ga-DOTATOC on our site with a new synthetizer - and clinically evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with 68Ga-DOTATOC in comparison with other standard imaging examinations.
    Mettre au point le radiomarquage du68Ga-DOTATOC sur notre site avec le nouveau synthétiseur et évaluer les performances diagnostiques de la TEP-TDM au 68Ga-DOTATOC en comparaison avec les examens conventionnels, dont la scintigraphie à l'Octréoscan®, avec comme gold standard l'histologie et/ou le suivi du patient.
    E.2.2Secondary objectives of the trial
    Confirm the reproducibility of the synthesis of 68Ga-DOTATOC
    Confirm the perfect tolerance of 68Ga-DOTATOC.
    Estimate the clinical impact of the use of PET-CT with 68Ga-DOTATOC within the examinations of imaging by the rate of modification of the therapeutic attitude by the analysis of questionnaire
    Confirmer la reproductibilité de la synthèse du 68Ga-DOTATOC
    Confirmer la parfaite tolérance du 68Ga-DOTATOC.
    Evaluer l’impact clinique de l’adoption de la TEP-TDM au 68Ga-DOTANOC au sein des examens d’imagerie par le taux de modification de l’attitude thérapeutique par l'analyse des questionnaires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients over 18 years
    - Patient who is suspected of endocrine tumors according to symptomatology, biology or imaging or pathological context (multiple endocrine neoplasia type 1)
    - initial staging: this includes research multifocal disease or locoregional or metastatic extension if well-differentiated neuroendocrine tumor (grade 1 et/ou 2)
    - Search of the primary tumor, especially in the case of the inaugural discovery of metastases
    - staging of a known recurrence
    - Search occult recurrence or suspicion of recurrence (clinical, laboratory, imaging doubtful)
    - Patient who have received in a lower range than 2 months of cervico-thoraco-abdominal-pelvic CT and scintigraphy in OctréoScan®
    - Patient who have signed an informed consent
    - Patient affiliated or beneficiary of regime of social security of a Member State of the European community
    - Patient de plus de 18 ans.
    - Patient suspect de tumeur endocrine selon la symptomatologie, la biologie ou l’imagerie d'une néoplasie endocrinienne multiple de type 1;
    - Bilan d’extension initial : ceci comprend la recherche de maladie multifocale, ou d’une extension locorégionale ou métastatique en cas de tumeur neuroendocrine bien différenciée (grade 1 et/ou 2)
    - Recherche de la tumeur primitive, notamment dans le cas de la découverte prévalente de métastases ;
    - Bilan d’extension d’une récidive connue
    - Recherche de récidive occulte ou suspicion de récidive (clinique, biologique, imagerie douteuse).
    - Le patient doit avoir bénéficié dans un intervalle inférieur à 2 mois d'une TDM cervico-thoraco-abdomino-pelvienne et d'une scintigraphie à l'OctréoScan®.
    - Consentement libre, éclairé et écrit signé.
    - Patient affilié ou bénéficiaire d’un régime de sécurité sociale d’un pays membre de la Communauté Européenne (article L1121-11 du Code de la Santé Publique).
    E.4Principal exclusion criteria
    - Patient with another evolutive cancer disease and/or treated for less than 5 years
    - Pregnant or lactating woman
    - Premenopausal woman without effective contraception (estrogen-progestin or intrauterine contraceptive device)
    - Patient unable to give their free and informed consent
    - Persons placed under judicial protection
    -Patient porteur d'une autre affection cancéreuse évolutive et/ou traitée depuis moins de 5 ans
    - Femme enceinte ou allaitant,
    - Femme non ménopausée sans contraception efficace en cours (dispositif intra-utérin ou oestroprogestatif),
    - Patient incapable de donner leur consentement libre et éclairé,
    - Personnes placées sous sauvegarde de justice (article L1122-2 du Code de la Santé Publique).
    E.5 End points
    E.5.1Primary end point(s)
    Diagnostic performance with 68Ga-DOTATOC PET-CT compared to standard examinations
    Performances diagnostiques de la TEP-TDM au 68Ga-DOTATOC es en comparaison avec les examens standard
    E.5.1.1Timepoint(s) of evaluation of this end point
    Inclusion
    Inclusion
    E.5.2Secondary end point(s)
    Impact on the therapeutic management of patients will be studied by the analysis of questionnaires with or without taking into account the results of the PET-CT with 68Ga-DOTATOC. Evaluate a potential change in the therapeutic attitude, induced by the results of 68Ga-DOTATOC PET-CT.
    Impact sur la prise en charge thérapeutique des patients par l'analyse des questionnaires de prise en charge en tenant compte ou non du résultat de la TEP-TDM au 68Ga-DOTATOC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Inclusion
    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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    imagerie conventionnelle radiologique et scintigraphique.
    conventional imaging
    E.8.2.4Number of treatment arms in the trial1
    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
    Dernière visite du dernier patient
    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) 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: 20
    F.1.3Elderly (>=65 years) Yes
    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 state20
    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)
    One objective of the trial is to evaluate a potential change in the therapeutic attitude, induced by the results of 68Ga-DOTATOC PET-CT.
    Un des objectifs de l'essai est d'évaluer le taux de modification de l’attitude thérapeutique dans la prise en charge de ces tumeurs.
    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 Decision2014-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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