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    The EU Clinical Trials Register currently displays   43847   clinical trials with a EudraCT protocol, of which   7282   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:2015-003317-22
    Sponsor's Protocol Code Number:2015_01
    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:2017-02-02
    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 number2015-003317-22
    A.3Full title of the trial
    111In-DTPA-exendine 4 PET/CT in patients with AHH – a prospective comparative evaluation of preoperative imaging
    Comparaison prospective de l’imagerie ciblée du récepteur du GLP-1 (technique à l’étude) par rapport à l’imagerie ciblée au
    récepteur de la somatostatine (technique standard), dans le bilan préopératoire chez les patients atteints de AHH (hypoglycémie
    hyper insulinique endogène de l’adulte) et notamment d’un insulinome.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of a new imaging technique to locate, prior to surgery, the lesions producing insulin in excess in patients with endogenous hyperinsulinar hypoglycemia.
    Evaluation d'une nouvelle technique d'imagerie pour localiser avant chirurgie les lésions produisant de l'insuline en excès chez les patients souffrant hypoglycémie hyper insulinique endogène de l’adulte.
    A.3.2Name or abbreviated title of the trial where available
    BetaCure
    A.4.1Sponsor's protocol code number2015_01
    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 SponsorCentre Hospitalier Régional Universitaire Lille
    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 supportCommission Européenne
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirection de la Recherche Clinique et de l'Innovation
    B.5.2Functional name of contact pointAmélie HERBAUT LECOCQ
    B.5.3 Address:
    B.5.3.1Street Address6 rue du Professeur Laguesse
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number003303 20 44 41 45
    B.5.5Fax number003303 20 44 57 11
    B.5.6E-maildrc@chru-lille.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 name111In-DTPA-Exendine-4
    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: 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 OctréoScan
    D.2.1.1.2Name of the Marketing Authorisation holderMALLINCKRODT MEDICAL B.V.
    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 name111In-DTPA-octreotide
    D.3.4Pharmaceutical form Lyophilisate and solvent for 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
    E.1.1.1Medical condition in easily understood language
    Patients suffering from insulinoma
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10061211
    E.1.2Term Hyperinsulinism
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparaison des sensibilités entre l’imagerie ciblée du récepteur du GLP-1 (technique à l’étude) par rapport à l’imagerie ciblée au récepteur de la somatostatine (technique standard), dans le bilan préopératoire chez les patients atteints de AHH (hypoglycémie hyper insulinique endogène de l’adulte) et notamment d’un insulinome.
    E.2.2Secondary objectives of the trial
    • Impact sur la gestion clinique de l'imagerie GLP-1R, et son utilisation possible en tant qu’examen standard pour l'imagerie préopératoire des patients AHH
    • Comparaison des résultats histologiques, immunohistochimiques et autoradiographiques des pièces opératoires à l’imagerie quantitative.
    • Etude dosimétrique : calcul de la dose efficace et par organe du 111In-DTPA-Exendin-4 SPECT/CT
    • Calculer et comparer la variabilité inter-observateur du 111In-DTPA-Exendin-4 SPECT/CT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age supérieur à 18 ans
    • Hypoglycémie hyper insulinémique neuroglycopénique prouvée par analyse biochimique montrant à jeun, une hypoglycémie, une hyper insulinémie et une concentration forte en C peptide.
    • Consentement, libre et éclairé, signé
    • Avoir réalisé l’imagerie standard dans un laps de temps de six semaines (CT triple phase, IRM, l'imagerie de récepteurs de la somatostatine (111In-DTPA-octreotide SPECT /CT), et écho endoscopie
    E.4Principal exclusion criteria
    • Femme allaitante
    • Femme enceinte ou ayant un projet de grossesse dans les 6 mois.
    • Clairance de la créatinine calculée inférieure à 40 ml/min.
    • Présence prouvée par imagerie conventionnelle d’une autre tumeur maligne que la tumeur produisant de l'insuline.
    (foie suspect, lésions osseuses et pulmonaires)
    • Âge <18 ans
    • Refus ou impossibilité de signer un consentement libre et éclairé
    E.5 End points
    E.5.1Primary end point(s)
    •Comparer les sensibilités entre l’imagerie ciblée du récepteur du GLP-1 (technique à l’étude) par rapport à l’imagerie ciblée au récepteur de la somatostatine (technique standard),
    E.5.1.1Timepoint(s) of evaluation of this end point
    Après la chirurgie. Maximum 8 semaines après l'imagerie ciblant les réepteurs de la GLP-1
    E.5.2Secondary end point(s)
    • (1) Le calcul de la dose d’organe et de la dose efficace en 111In-DTPA-exendin-4
    • (2) L’évaluation de l’impact sur la gestion clinique
    • (3) Le calcul de la variation inter observateur du 111In-DTPA-exendin-4 SPECT/CT par rapport au CT triple phase ou IRM
    • (4) La comparaison des paramètres d'imagerie, des constatations per opératoires, de l'histologie et de l'expression du récepteur GLP-1 / sst2 en autoradiographie in vitro sur des échantillons de tissus congelés
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1) à la sortie de l'étude (6 mois après l'imagerie ciblant les récepteurs de la GLP-1)
    (2) à la sortie de l'étude (6 mois après l'imagerie ciblant les récepteurs de la GLP-1)
    (3) Après l'imagerie ciblant les récepteurs de la GLP-1
    (4) à la sortie de l'étude (6 mois après l'imagerie ciblant les récepteurs de la GLP-1)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state28
    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
    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 Decision2017-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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