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    Summary
    EudraCT Number:2019-002729-31
    Sponsor's Protocol Code Number:PETCOLINA1-FINBA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-002729-31
    A.3Full title of the trial
    18F-fluorocholine PET/CT in primary hyperparathyroidism with negative preoperative localization
    PET/TC con 18F-Fluorocolina en el hiperparatiroidismo primario con localización prequirúrgica negativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Medical imaging using radioactive pharmaceuticals to localize abnormal parathyroid glands in patients with negative convenctional imaging, as a necessary condition for planning an optimal surgical treatment
    Diagnóstico por la imagen mediante fármacos radiactivos con el objetivo de localizar glándulas paratiroideas anómalas cuando las pruebas de imagen convencionales son negativas y así poder planificar de forma óptima el tratamiento quirúrgico
    A.3.2Name or abbreviated title of the trial where available
    PET/CT in hyperparathyroidism
    PET/TC en hiperparatiroidismo
    A.4.1Sponsor's protocol code numberPETCOLINA1-FINBA
    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 SponsorFundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA)
    B.1.3.4CountrySpain
    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 supportFundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA)
    B.5.2Functional name of contact pointFINBA
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Roma s/n
    B.5.3.2Town/ cityOviedo
    B.5.3.3Post code33011
    B.5.3.4CountrySpain
    B.5.4Telephone number+34985652521
    B.5.6E-mailelena.cienfuegosjovellanos_ccc@finba.es
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for injection
    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 INNFLUOROMETILCOLINA (18F)
    D.3.9.3Other descriptive nameFLUOROCHOLINE (18F) CHLORIDE
    D.3.9.4EV Substance CodeSUB184899
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number222 to 225
    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
    Primary hyperthyroidism
    Hiperparatiroidismo primario
    E.1.1.1Medical condition in easily understood language
    Primary hyperparathyroidism is a disorder in which one or more of the parathyroid glands secrete too much parathyroid hormone into the blood
    El hiperparatirodismo primario es una enfermedad en la que una o más glándulas paratiroideas secretan demasiada hormona paratiroidea a la sangre
    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 LLT
    E.1.2Classification code 10036693
    E.1.2Term Primary hyperparathyroidism
    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
    To evaluate the usefulness of PET-CT with 18F-Fluorocholine for preoperative localization of hyperfunctioning parathyroid glands in patients with primary hyperparathyroidism and negative conventional imaging (parathyroid scintigraphy and cervical ultrasound)
    Evaluar la utilidad de la PET-TC con 18F-Fluorocolina en el diagnóstico de localización prequirúrgico de glándulas paratiroideas hiperfuncionantes en pacientes con hiperparatiroidismo primario y pruebas de imagen convencionales negativas (gammagrafía paratiroidea y ecografía cervical)
    E.2.2Secondary objectives of the trial
    To investigate the correlation between SUVmax and clinical, analytical and pathological parameters.
    To perform a cost-effectiveness analysis
    Investigar la correlación entre el SUVmáx y los parámetros clínicos, analíticos y anatomopatológicos.
    Realizar un estudio de coste-efectividad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with primary hyperparathyroidism
    Eligible for parathyroid surgery
    Negative, inconclusive or discordant preoperative imaging (both parathyroid scintigraphy and cervical ultrasound), performed within 6 months before PET-CT scan with 18F-Fluorocholine
    Pacientes con hiperparatirodismo primario
    Candidatos a cirugía de paratiroides
    Pruebas de imagen prequirúrgicas negativas, no concluyentes o discordantes (tanto gammagrafía paratiroidea como ecografía cervical), realizardas dentro de los 6 meses previos a la PET-TC con 18F-Fluorocolina
    E.4Principal exclusion criteria
    Patients with familial isolated primary hyperparathyroidism
    Patients with multiple endocrine neoplasia (MEN)
    Patients with secondary or terciary hyperparathyroidism
    Patients with suspected thyroid or parathyroid cancer
    Pacientes con hiperparatiroidismo primario familiar aislado
    Pacientes diagnosticados de neoplasia endocrina múltiple (MEN)
    Pacientes con hiperparatiroidismo secundario o terciario
    Pacientes con sospecha de cáncer tiroideo o paratiroideo
    E.5 End points
    E.5.1Primary end point(s)
    Surgical resection of the hyperfunctioning parathyroid glands detected by PET-CT scan with 18F-Fluorocholine
    Resección quirúrgica de las glándulas paratiroideas hiperfuncionantes detectadas por la PET-TC con 18F-Fluorocolina
    E.5.1.1Timepoint(s) of evaluation of this end point
    Surgery must be performed within 3 months after the PET-CT scan
    La cirugía debe realizarse dentro de los 3 meses siguientes a la realización de la PET-TC
    E.5.2Secondary end point(s)
    Percentage of cured patients after surgery
    Porcentaje de curación tras la cirugía
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months after surgery
    3 meses tras la cirugía
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Cost-effectiveness
    Coste-efectividad
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    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
    Ninguno
    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 Decision2020-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-18
    P. End of Trial
    P.End of Trial StatusOngoing
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