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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2019-000274-36
    Sponsor's Protocol Code Number:APACH2
    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:2019-04-02
    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 number2019-000274-36
    A.3Full title of the trial
    Phase III trial comparing 2 diagnostic strategies for the preoperative localization of parathyroid adenoma in primary hyperparathyroidism:
    TEMP / CT with Tc99m-sestaMIBI or PET / CT with F18-choline in first intention
    Essai de phase III comparant 2 stratégies diagnostiques pour la localisation pré-opératoire d'adénome parathyroïdien dans l'hyperparathyroïdie primaire :
    TEMP/TDM au Tc99m-sestaMIBI ou TEP/TDM à la F18-choline en première intention
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III trial comparing 2 diagnostic strategies for the preoperative localization of parathyroid adenoma in primary hyperparathyroidism:
    TEMP / CT with Tc99m-sestaMIBI or PET / CT with F18-choline in first intention
    Essai de phase III comparant 2 stratégies diagnostiques pour la localisation pré-opératoire d'adénome parathyroïdien dans l'hyperparathyroïdie primaire :
    TEMP/TDM au Tc99m-sestaMIBI ou TEP/TDM à la F18-choline en première intention
    A.3.2Name or abbreviated title of the trial where available
    APACH2
    APACH2
    A.4.1Sponsor's protocol code numberAPACH2
    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 François Baclesse
    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 supportCentre François Baclesse
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre François Baclesse
    B.5.2Functional name of contact pointElisabeth QUAK
    B.5.3 Address:
    B.5.3.1Street Address3 avenue général Harris
    B.5.3.2Town/ cityCaen
    B.5.3.3Post code14076
    B.5.3.4CountryFrance
    B.5.4Telephone number33231455002
    B.5.5Fax number33231455158
    B.5.6E-maile.quak@baclesse.unicancer.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 Yes
    D.2.1.1.1Trade name Fluorochol
    D.2.1.1.2Name of the Marketing Authorisation holderADVANCED ACCELERATOR APPLICATIONS
    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 nameFluorocholine (18F)
    D.3.4Pharmaceutical form Radiopharmaceutical precursor, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluorochol
    D.3.9.2Current sponsor code18 Fluorocholine
    D.3.9.3Other descriptive nameFLUOROCHOLINE (18F)
    D.3.9.4EV Substance CodeSUB181840
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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
    Patient with primary hyperparathyroidism and for which surgical resection is provided.
    Patient présentant une hyperparathyroïdie primaire et pour lequel une chirurgie d’exérèse est prévue.
    E.1.1.1Medical condition in easily understood language
    Patient with primary hyperparathyroidism and for which surgical resection is provided.
    Patient présentant une hyperparathyroïdie primaire et pour lequel une chirurgie d’exérèse est prévue.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020705
    E.1.2Term Hyperparathyroidism
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique (SPECT/CTD at MIBI or PET/CT at FCH) has guided the surgical procedure appropriately (decision of true positive minimally invasive surgery and patient recovery)
    Comparer, entre chaque stratégie diagnostique, la proportion de patients pour laquelle la technique d’imagerie de première ligne (TEMP/TDM au MIBI ou TEP-TDM à la FCH) a permis de guider la procédure chirurgicale à bon escient (décision de chirurgie mini-invasive vraie positive et obtention d’une guérison du patient)
    E.2.2Secondary objectives of the trial
    - Carry out a medico-economic evaluation comparing the costs and effectiveness of the two diagnostic strategies
    - Estimate the diagnostic performance of each strategy
    - Evaluate the number of parathyroid surgery failures at 6 months (regardless of the type of surgery performed) for each strategy
    - Evaluate post-surgical complications
    - Evaluate intra- and inter-observer variability for the interpretation of PET-MT at FCH and SPECT-MT at MIBI
    - Explore the relationship between the positivity of imaging tests, including PET/CT to FCH and serum PTH concentration at inclusion
    - Evaluate the detection performance of PET-TDM at FCH over an early imaging time of 10 min post-injection compared to the acquisition performance at 60 min.
    - Réaliser une évaluation médico-économique comparant les coûts et l’efficacité des deux stratégies diagnostiques
    - Estimer les performances diagnostiques de chaque stratégie
    - Évaluer le nombre d'échecs à 6 mois de la chirurgie parathyroïdienne (quel que soit le type de chirurgie réalisée) pour chaque stratégie
    - Evaluer les complications post-chirurgicales
    - Evaluer la variabilité intra et inter observateur pour l’interprétation de la TEP-TDM à la FCH et de la TEMP/TDM au MIBI
    - Explorer la relation entre la positivité des examens d’imagerie, notamment de la TEP-TDM à la FCH et la concentration sérique de PTH à l’inclusion
    - Evaluerles performances de détection de la TEP-TDM à la FCH sur un temps d’imagerie précoce à 10 min post-injection comparativement à celles de l’acquisition à 60 min.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 18 years of age
    - Patient with primary hyperparathyroidism for whom excisional surgery is planned
    - Biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum PTH and calcium concentrations)
    - Affiliation to a social security system
    - Patient who has signed his written consent
    - Patient âgé de 18 ans révolu
    - Patient présentant une hyperparathyroïdie primaire et pour lequel une chirurgie d’exérèse est prévue
    - Bilan biologique confirmant le diagnostic d’hyperparathyroïdie primaire (concentrations sériques de PTH et de calcium élevées)
    - Affiliation à un régime de la sécurité sociale
    - Patient ayant signé son consentement écrit
    E.4Principal exclusion criteria
    - Patient deprived of liberty, under guardianship or curatorship
    - Hypersensitivity to TECNESCAN SESTAMIBI
    - Any associated medical or psychological condition that could compromise the patient's ability to participate in the study
    - Pregnant or breastfeeding woman
    - History of parathyroid surgery
    - Patient with Multiple Endocrine Neoplasia 1 (MEN1)

    - Patient privé de liberté, sous tutelle ou curatelle
    - Hypersensibilité au TECNESCAN SESTAMIBI
    - Toute condition médicale ou psychologique associée qui pourrait compromettre la capacité du patient à participer à l’étude
    - Femme enceinte ou allaitant
    - Antécédent de chirurgie des parathyroïdes
    - Patient atteint de néoplasie endocrinienne multiple 1 (NEM1)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients for whom the first-line imaging technique (SPECT/CTD at MIBI or PET/CTD at FCH) has been successful in guiding the surgical procedure appropriately as defined by:
    - a decision to perform positive (and appropriate) true minimally invasive surgery
    AND
    - the patient's recovery, defined by normalization of blood calcium and PTH at one month and 6 months post-surgery
    Proportion de patients pour lesquels la technique d’imagerie de première ligne (TEMP/TDM au MIBI ou TEP-TDM à la FCH) a permis de guider la procédure chirurgicale à bon escient définie par :
    • une décision de réaliser une chirurgie mini-invasive vraie positive (à bon escient)
    ET
    • l’obtention d’une guérison du patient, définie par une normalisation de la calcémie et de la PTH à un mois et à 6 mois post-chirurgie
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery

    Après chirurgie
    E.5.2Secondary end point(s)
    - Average cost of managing a patient for each of the two strategies
    - Sensitivity, specificity, error rates, positive and negative likelihood ratios of PET/CT to FCH and SPECT/CT to MIBI
    - Rates of minimally invasive surgery and bilateral cervical explorations for each diagnostic strategy
    - Number of parathyroid surgery failures (regardless of the type of surgery performed), defined by the persistence of primary hyperparathyroidism 6 months after surgery
    - Complications occurring within one month of surgery: infections, haematomas, laryngeal recurrent nerve damage
    - Cohen's kappa coefficients between the 2 independent readers, at their first reading, then at their second reading (3 months later); as well as between the first and second readings of each of the 2 readers
    - Serum PTH concentration at inclusion
    - Compare the detection sensitivities of PET-DMT to FCH at 10 min and 60 min post-injection, as well as the semi-quantitative analysis.
    - Coût moyen de prise en charge d'un patient pour chacune des deux stratégies
    - Sensibilité, spécificité, taux d’erreurs, rapports de vraisemblance positif et négatif de la TEP-TDM à la FCH et de la TEMP/TDM au MIBI
    - Taux de chirurgies mini-invasives et d’explorations cervicales bilatérales pour chaque stratégie diagnostique
    - Nombre d'échecs de la chirurgie parathyroïdienne (quel que soit le type de chirurgie réalisée), définis par la persistance d'une hyperparathyroïdie primaire 6 mois après la chirurgie
    - Complications survenant dans le mois suivant la chirurgie : infections, hématomes, lésion du nerf récurrent laryngé
    - Coefficients kappa de Cohen entre les 2 lecteurs indépendants, lors de leur première lecture, puis lors de leur seconde lecture (3 mois après) ; ainsi qu’entre la première et la seconde lecture de chacun des 2 lecteurs
    - Concentration sérique de PTH à l’inclusion
    - Comparerles sensibilités de détection de la TEP-TDM à la FCH à 10 min et à 60 min post-injection, ainsi que l’analyse semi-quantitative.
    rmation in other language that is applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    After surgery
    Après chirurgie
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state58
    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
    Non
    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 Decision2019-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
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