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    Summary
    EudraCT Number:2013-004033-32
    Sponsor's Protocol Code Number:RADIOMEN
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-10-16
    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 number2013-004033-32
    A.3Full title of the trial
    AN OPEN, MONOCENTRIC, NOT CONTROLLED CLINICAL TRIAL TO DEVELOP AND EVALUATE THE CLINICAL APPLICATION OF A NEW BETA PROBE FOR RADIOGUIDED SURGERY IN MENINGIOMA TUMOR
    STUDIO ESPLORATIVO, MONOCENTRICO NON CONTROLLATO IN APERTO, VOLTO A SVILUPPARE E VALUTARE L’APPLICAZIONE DI UNA TECNICA INNOVATIVA DI RIMOZIONE RADIOGUIDATA DEI TUMORI CEREBRALI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RADIOGUIDED SURGERY IN MENINGIOMA TUMOR
    RIMOZIONE RADIOGUIDATA DI TUMORI CEREBRALI
    A.4.1Sponsor's protocol code numberRADIOMEN
    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 SponsorFONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    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 supportUniversità di Roma "La Sapienza"
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportIstituto Italiano di Tecnologia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    B.5.2Functional name of contact pointRENATO MANTEGAZZA
    B.5.3 Address:
    B.5.3.1Street AddressVIA CELORIA 11
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number+390223942321
    B.5.5Fax number+390223943569
    B.5.6E-mailcrc@istituto-besta.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 name90Y-Dotatoc (DOTA-D-Phe-Tyr-OCTREOTIDE)
    D.3.2Product code 90 Y-Dotatoc
    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 INNOCTREOTIDE
    D.3.9.1CAS number 83150-76-9
    D.3.9.4EV Substance CodeSUB09417MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.1 to 0.25
    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
    SUBJECTS WITH CONVEXITY MENINGIOMA TUMORS OF NEW DIAGNOSIS
    PAZIENTI CON MENINGIOMA DELLA CONVESSITA' CEREBRALE DI PRIMA DIAGNOSI
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH BRAIN TUMORS
    PAZIENTI CON TUMORE CEREBRALE
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Toassess feasibility, specificity and sensibility of the probe during meningioma surgery
    Validare l’uso intraoperatorio della sonda analizzandone sensibilità e specificità nella chirurgia dei meningiomi della convessità cranica
    E.2.2Secondary objectives of the trial
    NOT APPLICABLE
    NON APPLICABILE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age >18, male and females
    -greatest transverse lesion diameter >10mm in Brain MRI or CT scan with and without contrast agents
    - diagnostic PET/CT with 68Ga-DOTATOC showing a significant uptake in the tumor (>liver) (SSR-positive tumour)
    -Adequate cardiac function (ECG) and conserved hematological, liver and renal parameters
    -Before the beginning of the trial, each patient will sign an informed consent
    -A negative pregnancy test not older than 7 days is mandatory for women in childbearing age
    a) Pazienti di entrambi i sessi di età superiore ai 18 anni
    b) Pazienti con evidenza RM o TC encefalo con e senza mdc di sospetto meningioma della convessità cranica di prima diagnosi, con diametro trasversale >1cm
    c) Presenza di un esame PET/TC con 68Ga-DOTATOC che mostri un significativa captazione (>rispetto al fegato) del tracciante a livello del tumore (SSR-positivo)
    d) Funzionalità cardiaca, epatica e renale verificate con esami strumentali (ECG) e di laboratorio (dosaggi ematici creatinina, transaminasi, gamma-GT, fosfatasi alcalina, sodio e potassio)
    e) Sottoscrizione consenso informato
    f) Nelle donne in età riproduttiva è necessario un test di gravidanza negativo (dosaggio ematico della beta HCG) non più vecchio di 7 giorni
    E.4Principal exclusion criteria
    - Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers)
    - Documented contrast agents allergy
    -Pregnancy/breastfeeding
    - Meningioma recurrences
    a) Pregressi tumori maligni in altre localizzazioni in corso di terapia o comunque non
    considerati guariti ad eccezione basaliomi in situ e tumori cervicali radicalmente
    asportati
    b) Alergia nota a mezzi di contrasto e/o pregressi shock anafilattici
    c) Donne in stato di gravidanza o allattamento
    d) Meningiomi recidivi
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of sensibility and specifity of the probe to detect the radiotracer up-take during intracranial convexity meningioma surgery
    Valutazione della sensibilità e della specificità della sonda nel rilevare l’up-take del tracciante nella chirurgia dei meningiomi endocranici della convessità.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T0 and T36
    T0 e T36
    E.5.2Secondary end point(s)
    - To minimize the delivered radiation dose.
    - To evaluate the residual radiations modifying the dose injected
    - To evaluate the radiation exposure of the personnel
    - To optimized probe
    - Toxicity
    1. Valutazione della dose minima che occorre somministrare al paziente
    2. Valutazione del residuo minimo che questa tecnica e’ in grado di valutare al variare della dose somministrata
    3. Valutazione della radiazione per il personale
    4. Ottimizzazione della sonda
    5. Tossicità
    E.5.2.1Timepoint(s) of evaluation of this end point
    During all the period of study
    Durante tutto lo studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    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 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
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 2013-10-16. 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 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)
    Normal Clinical Follow up for patients affected by meningiomas.
    I pazienti proseguiranno il follow up secondo normale pratica clinica prevista per i meningiomi.
    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 Decision2013-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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