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    Summary
    EudraCT Number:2011-003036-31
    Sponsor's Protocol Code Number:01B
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-003036-31
    A.3Full title of the trial
    Ministry of health integrated oncological program n°5/2006: 18F-Fluorometilcholine (18FFCH) PET/CT sensibility in diagnosis of breast cancer metastasis
    Programma integrato di oncologia n. 5/2006 del Ministero della Salute: sensibilita' dell'esame PET/CT con 18F-Fluorometilcolina (18F-FCH) nella diagnosi delle metastasi da carcinoma mammario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    18F-Fluorometilcholine (18F-FCH) PET/CT sensibility in diagnosing breast cancer metastasis
    sensibilita' della 18F-Fluorometilcolina (18F-FCH) PET/CT nella diagnosi delle metastasi del cancro mammario
    A.3.2Name or abbreviated title of the trial where available
    N5/2006 - 01B
    N5/2006 - 01B
    A.4.1Sponsor's protocol code number01B
    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 SponsorAZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
    B.1.3.4CountryItaly
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria Careggi
    B.5.2Functional name of contact pointMedicina Nucleare Biomolecolare
    B.5.3 Address:
    B.5.3.1Street AddressViale Morgagni 85
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50134
    B.5.3.4CountryItaly
    B.5.4Telephone number055 7947527
    B.5.6E-maila.pupi@dfc.unifi.it
    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 name18F-Fluorometilcholine
    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 INN18F-Fluorometilcholine
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number222
    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
    de novo breast cancer metastasis
    metastasi de novo da carcinoma mammario pregresso
    E.1.1.1Medical condition in easily understood language
    de novo breast cancer metastasis
    nuova diagnosi di metastasi da carcinoma mammario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluation of 18F-FCH PET/CT for diagnosis of de novo breast cancer metastasis
    valutazione della sensibilità diagnostica della PET/CT eseguita con tracciante 18F-FCH nella diagnosi della recidiva metastatica de novo in pazienti con pregresso carcinoma mammario arruolate retrospettivamente
    E.2.2Secondary objectives of the trial
    optimization of post iniective PET/CT scanning time
    ottimizzazione dei tempi di scansione PET/CT post iniettivi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -female gender subjects only -previous primary breast cancer, radically treated to complete clinical remission, to clinician’s judgement -availability of clinical and pathologic documentation of primary disease, to be considered satisfactory to investigator’s judment (generally comprising histological diagnosis, assessment of ER, PgR, Erb-B2 status, pathologicl staging at diagnosis, plasma levels of CEA and 15.3, etc) -subjects must have been enrolled in routinary clinical follow-up schedule in oncologic centres -chemotherapy and/or radiotherapy ceased for at least 6 months -hormonal therapy allowed, to be suspended for 10 days after enrollment, till PET/CT examination -estabilished recent diagnosis of previously unrecognized metastatic disease diagnosis of metastatic disease should be estabilished on the basis of radiological evidence; full documentation of restaging need to be avalaible. Histological confirmation is preferred, but is not obligatory. Biopsy should be not more recent than 30 days. Some kinds of radiological examinations are to be considered obligatory (bone scan, whole body CT, MRI utilized for osseous lesions referred as suspect in bone scans for vertebrae, skull, pelvic bones, long bones).
    1-Pazienti di sesso femminile, con pregressa storia clinica di cancro mammario, inserite in un programma di follow-presso centri oncologici ospedalieri ed universitari; 2-le Pazienti dovranno essere in possesso di documentazione clinico-patologica della malattia primaria, ritenuta esauriente dallo Sperimentatore, ed in genere comprendente istopatologia, grading, status dei recettori ER, PgR, erb-B2, Ki-67, stadiazione patologica, e determinazione dei valori sierici CEA e CA-15.3 alla diagnosi; 3-le Pazienti dovranno essere state sottoposte a terapia primaria radicale, e ritenute a giudizio clinico in remissione completa di malattia al termine di questa; 4-le Pazienti dovranno avere cessato la eventuale chemioterapia e/o radioterapia da almeno 6 mesi; è ammessa invece la contemporanea somministrazione di terapia ormonale, che sarà comunque sospesa almeno dieci giorni prima dell’esecuzione dell’esame PET/CT. 5-diagnosi recente di malattia metastatica non precedentemente riconosciuta e stabilita sulla base dell'evidenza radiologica (deve essere disponibile una completa documentazione relativa al restaging); la conferma bioptica è preferibile ma non obbligatoria. Alcuni esami radiologici devono essere considerati obbligatori (scintigrafia ossea, TC full body, risonanza magnatica per almeno una lesione ossea considerata sospetta alla scintigrafia ossea, a livello di vertebre, cranio, ossa pelviche e ossa lunghe)
    E.4Principal exclusion criteria
    -pregnancy -chemotherapy or radiotherapy administration in previous 6 months -presence of different oncologic disease, including leukemia, lymphoma, plasma cell disease -presence of chronic liver disease, including chronic hepatitis ans cirrhosis -Karnofsky performance status <80% -actual or previous enrollment in different clinical trials with administration of ionizing radiation -ionizing radiation exposure due to work or profession -recent surgery or biopsies (<30 days) -inability to understand or subscribe an informed consent to participate to clinical trials, including being minor.
    -sospetto di gravidanza; -somministrazione di radio- o chemo-terapia nei sei mesi precedenti -pregressa diagnosi di altre patologie neoplastiche, comprese forme leucemiche, linfomatose e discrasie plasmacellulari -presenza di patologie epatiche croniche a carattere flogistico e/o cirrosi -performance status (&lt;80% della scala di Karnofsky) -partecipazione in atto o pregressa ad altri trials clinici che prevedano esposizione a radiazioni ionizzanti -attività lavorativa che preveda esposizione a radiazioni ionizzanti -esecuzione recente (&lt;30 giorni) di biopsia sulle lesioni di interesse -minore età -incapacità di comprendere validamente e/o firmare i documenti di consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    none
    non applicabile
    E.5.1.1Timepoint(s) of evaluation of this end point
    none
    non applicabile
    E.5.2Secondary end point(s)
    none
    non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    none
    non applicabile
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    analysis of last group of experimental examinations
    analisi della ultima tranche dei referti dell'esame sperimentale
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.1Number of subjects for this age range: 0
    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: 35
    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 No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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
    nessuno
    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 Decision2012-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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