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    Summary
    EudraCT Number:2015-005017-71
    Sponsor's Protocol Code Number:CHOCOLATE
    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:2015-12-03
    Trial results View 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 number2015-005017-71
    A.3Full title of the trial
    Diagnostic value of 18F-choline PET in patients with indeterminate cytology thyroid nodule : A pilot study
    Intérêt diagnostique de la TEP à la 18-F Choline chez les patients porteurs d’un nodule thyroïdien à cytologie indéterminée : Etude pilote
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic value of 18F-choline PET in patients with indeterminate cytology thyroid nodule : A pilot study
    Intérêt diagnostique de la TEP à la 18-F Choline chez les patients porteurs d’un nodule thyroïdien à cytologie indéterminée : Etude pilote
    A.3.2Name or abbreviated title of the trial where available
    CHOCOLATE
    CHOCOLATE
    A.4.1Sponsor's protocol code numberCHOCOLATE
    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 pointRenaud CIAPPUCCINI
    B.5.3 Address:
    B.5.3.1Street Address3 avenue du général Harris
    B.5.3.2Town/ cityCaen
    B.5.3.3Post code14076
    B.5.3.4CountryFrance
    B.5.4Telephone number33231455032
    B.5.5Fax number33231455101
    B.5.6E-mailr.ciappuccini@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 IASOcholine
    D.2.1.1.2Name of the Marketing Authorisation holderAdvanced Accelerator Application
    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 nameFlurocholine (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 INNIASOcholine
    D.3.9.2Current sponsor code18 Fluorocholine
    D.3.9.3Other descriptive name18F-FLUOROMETHYLCHOLINE
    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 a thyroid nodule ≥15mm with indefinite cytology according to the 2008 Bethesda classification (vesicular lesion of undetermined significance; follicular neoplasm or cell Hürthle; lesion suspicious for malignancy), and to be operated
    Patient présentant un nodule thyroïdien ≥15 mm à cytologie indéterminée d'après la classification de Bethesda 2008 (Lésion vésiculaire de signification indéterminée; Néoplasme folliculaire ou à cellules de Hürthle; Lésion suspecte de malignité), et devant être opéré.
    E.1.1.1Medical condition in easily understood language
    Patient with a thyroid nodule ≥15mm with indefinite cytology according to the 2008 Bethesda classification and to be operated
    Patient présentant un nodule thyroïdien ≥15 mm à cytologie indéterminée d'après la classification de Bethesda 2008 et devant être opéré.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10043747
    E.1.2Term Thyroid neoplasms
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Establish the sensitivity of PET with 18F-choline to detect, among the patients with thyroid nodule with indeterminate cytology in the cases of thyroid cancer, taking as reference the histology of the nodule (WHO 2004 classification) after surgery.
    Etablir la sensibilité de la TEP à la 18F-Choline pour détecter, parmi les patients présentant un nodule thyroïdien à cytologie indéterminée, les cas de cancer thyroïdien, en prenant comme référence l’histologie du nodule (Classification OMS 2004) après chirurgie.
    E.2.2Secondary objectives of the trial
    Estimate the diagnostic capabilities of PET with 18F-Choline in predicting thyroid cancers, as well as the optimal time required for the acquisition of the PET image centered on the cervical region .
    Estimer les capacités diagnostiques de la TEP à la 18F-Choline dans la prédiction des cancers thyroïdiens, ainsi que la durée optimale nécessaire à l’acquisition de l’image TEP centrée sur la région cervicale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient with a thyroid nodule ≥ 15mm with indefinite cytology according to the 2008 Bethesda classification (vesicular lesion of undetermined significance; follicular neoplasm or cell Hürthle; lesion suspicious for malignancy), and to be operated
    - Age ≥ 18 years
    - Patient affiliated to a social security scheme
    - Informed consent and signed
    - Patient présentant un nodule thyroïdien ≥15 mm à cytologie indéterminée d'après la classification de Bethesda 2008 (Lésion vésiculaire de signification indéterminée; Néoplasme folliculaire ou à cellules de Hürthle; Lésion suspecte de malignité), et devant être opéré
    - Age ≥ 18 ans
    - Patient affilié à un régime de sécurité sociale
    - Consentement éclairé et signé
    E.4Principal exclusion criteria
    - Thyroid nodule <15mm
    - Coalescing nodules preventing a correct individualization of the target nodule;
    - Nodules with no indeterminate cytology , ie nondiagnostic cytology, benign and malignant cytology
    - Major subject of a legal protection measure or unable to consent
    - Refusal to participate
    - Nodule thyroïdien <15 mm
    - Nodules coalescents empêchant une individualisation correcte du nodule ciblé;
    - Nodule avec cytologie non indéterminée, i.e. cytologie non diagnostique, cytologie bénigne et cytologie maligne
    - Majeurs faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer leur consentement
    - Refus de participation
    E.5 End points
    E.5.1Primary end point(s)
    Sensitivity
    Sensibilité
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery
    Après chirurgie
    E.5.2Secondary end point(s)
    Specificity,error rate,positive and negative likilihood ratios of PET-CT to CHT
    Spécificité ,taux d’erreur,rapports de vraisemblance positif et négatif de la TEP à la 18F-Choline
    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) 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
    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 months0
    E.8.9.1In the Member State concerned 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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 state135
    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 Decision2016-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-15
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