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    Summary
    EudraCT Number:2010-023935-41
    Sponsor's Protocol Code Number:PET-BRCA-2010
    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:2012-04-12
    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 number2010-023935-41
    A.3Full title of the trial
    PILOT STUDY ASSESSING THE EFFECTIVENESS OF 18FDG PET-CT IN THE EARLY DIAGNOSIS OF BREAST CANCER AND / OR OVARIAN CANCER IN WOMEN BRCA1 or BRCA 2 MUTATION CARRIERS
    ESTUDIO PILOTO PARA LA VALORACION DE LA EFECTIVIDAD DEL PET-TAC CON 18FDG EN EL DIAGNOSTICO PRECOZ DE CANCER DE MAMA Y/U OVARIO EN MUJERES PORTADORAS DE MUTACIÓN EN LOS GENES BRCA1 O BRCA2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PILOT STUDY ASSESSING THE EFFECTIVENESS OF 18FDG PET-CT IN THE EARLY DIAGNOSIS OF BREAST CANCER AND / OR OVARIAN CANCER IN WOMEN BRCA1 or BRCA 2 MUTATION CARRIERS
    ESTUDIO PILOTO PARA LA VALORACION DE LA EFECTIVIDAD DEL PET-TAC CON 18FDG EN EL DIAGNOSTICO PRECOZ DE CANCER DE MAMA Y/U OVARIO EN MUJERES PORTADORAS DE MUTACIÓN EN LOS GENES BRCA1 O BRCA2
    A.4.1Sponsor's protocol code numberPET-BRCA-2010
    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 SponsorConsorcio de Apoyo a la Investigación Biomédica en Red (CAIBER)
    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 supportConsorcio de Apoyo a la Investigación Biomédica en Red (CAIBER)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorcio de Apoyo a la Investigación Biomédica en Red (CAIBER)
    B.5.2Functional name of contact pointRocío Arce
    B.5.3 Address:
    B.5.3.1Street AddressC/ Melchor Fernández Almagro 3 Pabellón 13 Planta 1ª
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28029
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918222422
    B.5.5Fax number+34918222516
    B.5.6E-mailrarce@caiber.net
    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 Fludesoxiglucosa
    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 name18FDG
    D.3.2Product code 18FDG
    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 INNFLUDESOXIGLUCOSA (18F)
    D.3.9.3Other descriptive nameFLUDEOXYGLUCOSE (18F)
    D.3.10 Strength
    D.3.10.1Concentration unit Bq becquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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
    Breast cancer screening in women BRCA1 or BRCA2 mutation.
    screening de cáncer de mama en mujeres portadoras de mutación BRCA1 o BRCA2.
    E.1.1.1Medical condition in easily understood language
    Breast cancer screening in women BRCA1 or BRCA2 mutation
    screening de cáncer de mama en mujeres portadoras de mutación BRCA1 o BRCA2.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1.Evaluar la efectividad del PET-TAC frente a la RMN de mama en la detección precoz de lesiones malignas y premalignas de mama en mujeres sanas portadoras de mutación en los genes BRCA1 o BRCA2.
    E.2.2Secondary objectives of the trial
    2. Comparar los resultados de detección de dichas lesiones mamarias en
    PET-TAC frente al resto de las pruebas del programa habitual de seguimiento planteado en todas las Unidades de Consejo Genético participantes en el estudio.

    3. Comparar los resultados de detección de lesiones ováricas en PET TAC frente al resto de las pruebas del programa habitual de seguimiento planteado en todas las Unidades de Consejo Genético participantes en el estudio.

    4. Comparar la efectividad de las diferentes pruebas según la confirmación histológica de las lesiones.

    5. Descripción de los resultados histológicos en aquellas lesiones que aparezcan en alguna de las pruebas realizadas en las mujeres estudiadas.

    6. Análisis del coste de PET TAC en comparación con el resto de las pruebas habituales
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.- Mujeres mayores de 18 años.

    2.- No diagnosticadas de cáncer previo a su entrada en el estudio.

    3.- Portadoras de alguna mutación patogénica en los genes BRCA1 o 2.

    4.- No existir contraindicación para la realización de PET-TAC con 18FDG o alguna de las pruebas habituales de seguimiento programadas para su grupo de riesgo.

    5.- Haber firmado el consentimiento informado.
    E.4Principal exclusion criteria
    1.- Haber sido diagnosticadas de algún cáncer previo a la entrada en el estudio.

    2.- Ser menor de 18 años.

    3.- Haberse sometido a algún tipo de cirugía preventiva a nivel mamario y/u ovárico previo a su entrada en el estudio.

    4.- No cumplir alguno de los criterios de inclusión.

    5.- Uso de metformina.
    E.5 End points
    E.5.1Primary end point(s)
    Detection of breast lesions in which imaging tests are determined histologically confirmed malignant or premalignant breast.
    Detección de lesiones mamarias en las pruebas de imagen cuya confirmación histológica determine que son lesiones malignas o premalignas de mama
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    1 mes
    E.5.2Secondary end point(s)
    1.Comparar los resultados de detección de dichas lesiones mamarias en PET-TAC frente al resto de las pruebas del programa habitual de seguimiento planteado en todas las Unidades de Consejo Genético participantes en el estudio.
    2.Comparar los resultados de detección de lesiones ováricas en PET TAC frente al resto de las pruebas del programa habitual de seguimiento planteado en todas las Unidades de Consejo Genético participantes en el estudio.
    3.Comparar la efectividad de las diferentes pruebas según la confirmación histológica de las lesiones.
    4.Descripción de los resultados histológicos en aquellas lesiones que aparezcan en alguna de las pruebas realizadas en las mujeres estudiadas.
    5.Análisis del coste de PET TAC en comparación con el resto de las pruebas habituales.
    1.Comparar los resultados de detección de dichas lesiones mamarias en PET-TAC frente al resto de las pruebas del programa habitual de seguimiento planteado en todas las Unidades de Consejo Genético participantes en el estudio.

    2.Comparar los resultados de detección de lesiones ováricas en PET TAC frente al resto de las pruebas del programa habitual de seguimiento planteado en todas las Unidades de Consejo Genético participantes en el estudio.

    3.Comparar la efectividad de las diferentes pruebas según la confirmación histológica de las lesiones.

    4.Descripción de los resultados histológicos en aquellas lesiones que aparezcan en alguna de las pruebas realizadas en las mujeres estudiadas.

    5.Análisis del coste de PET TAC en comparación con el resto de las pruebas habituales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. one month
    2. one month
    3. two months
    4. two months
    5. two months
    1. un mes
    2. un mes
    3. dos meses
    4. dos meses
    5. dos meses
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    estudio piloto cuasiexperimental
    estudio piloto cuasiexperimental
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    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
    EL FINAL DEL ENSAYO SE CONSIDERA LA ULTIMA VISITA DEL ULTIMO SUJETO INCLUIDO
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-04-12. Yes
    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 state234
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 234
    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)
    TRAS LA FINALIZACIÓN SEGUIRÁN SUS CONTROLES HABITUALES.
    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 Decision2011-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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