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    Summary
    EudraCT Number:2018-004667-30
    Sponsor's Protocol Code Number:Rame-03
    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:2021-04-16
    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 number2018-004667-30
    A.3Full title of the trial
    Diagnostic and clinical value of 64CuCl2 in HGG/DIPG
    Ruolo diagnostico e aspetti dosimetrici del 64CuCl2 nei Gliomi infiltranti ad alto grado dell’età pediatrica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic value of 64CuCl2 in high grade glioma
    Valore diagnostico del dicloruro di rame-64 nei Gliomi infiltranti ad alto grado dell’età pediatrica
    A.3.2Name or abbreviated title of the trial where available
    64CuCl2 in high grade glioma
    64CuCl2 nei Gliomi infiltranti ad alto grado
    A.4.1Sponsor's protocol code numberRame-03
    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 SponsorENTE OSPEDALIERO OSPEDALI GALLIERA
    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 supportCompagnia di San Paolo
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportSPARKLE srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationE.O. Ospedali Galliera
    B.5.2Functional name of contact pointS.C. Medicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressMura delle Cappuccine 14
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16128
    B.5.3.4CountryItaly
    B.5.4Telephone number0105634541
    B.5.6E-mailarnoldo.piccardo@galliera.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 name64RAME CLORURO
    D.3.2Product code [64Cu(II)Cl2]
    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 INNrame cloruro ( 64CuCl2)
    D.3.9.2Current sponsor code(64Cu)CuCl2
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number925
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    pediatric patients with HGG/DIPG
    pazienti pediatrici affetti da gliomi ad alto grado o tumori intrinseci diffusi del ponte
    E.1.1.1Medical condition in easily understood language
    pediatric patients (aged between 5 and 18 years) with HGG/DIPG
    pazienti pediatrici (età compresa tra i 5 e i 18 anni) affetti da glioma ad alto grado o tumori diffusi intrinseci del ponte
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Evaluate the diagnostic accuracy of 64CuCl2-PET / CT in identifying HGG and DIPG
    Correlate the intensity of 64CuCl2 with tumor aggressiveness
    Evaluate the prognostic impact of 64CuCl2 (i.e. the ability to identify patients at increased risk of disease progression)
    Valutare l’accuratezza diagnostica della 64CuCl2- PET/CT nell’identificare gli HGG e i DIPG;
    Correlare l’intensità del 64CuCl2 con l’aggressività tumorale;
    Valutare l’impatto prognostico del 64CuCl2 (i.e. la capacità di identificare i pazienti a maggior rischio di progressione di malattia)
    E.2.2Secondary objectives of the trial
    To study biodistribution, kinetics and dosimetry based on MIRD method of 64CuCl2 both in the tumor lesion and in the organs
    Evaluating the Tumor to Background ratio (TBR) of 64CuCl2 in function of time
    Evaluate the safety and tolerance of 64CuCl2 and possible occurrence of adverse events
    Studiare la biodistribuzione, la cinetica e la dosimetria basata sul metodo MIRD del 64CuCl2 sia nella lesione tumorale sia negli organi;
    Valutare l’andamento temporale del Tumour to Background ratio (TBR) del 64CuCl2;
    Valutare la sicurezza e la tolleranza del 64CuCl2 e l’eventuale insorgenza di eventi avversi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or radiologically confirmed High grade Glioma or diffuse intrinsic pontine glioma (DIPG)

    2. Measurable disease (at least one objectively bi-dimensionally measurable lesion (> 1 cm in its largest
    dimension by RM scan) as demonstrated by RM scan.

    3.KPS = 60.

    4. A life expectancy > 3 months.

    5. Male or female aged ranging from 5 to 18 years.
    6. Normal marrow function defined as:
    a. Absolute neutrophil count = 1.5 x 109/l
    b. Platelet count = 150 x 109/l
    c. Haemoglobin = 9 g/dl.
    7. Adequate hepatic function, defined as:
    a. AST/ALT = 2.5 x upper limit of normal (ULN) (or = 5.0 x ULN if liver involvement by primary disease) direct bilirubin = 1.5 ULN
    b. Normal ALP values
    c. Normal coagulation parameters.
    8. Adequate renal function as demonstrated by a serum creatinine = 1.5 mg/dl or a creatinine clearance > 60 ml/min.
    9. Negative human chorionic gonadotropin (hCG) test in women of childbearing potential. Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 4 months after final administration of 64CuCl2, or the patient must be sterile (with documentation in the patient’s medical records).
    Note: Sterility (in female patients) must be confirmed in the patients’ medical records and can be defined as any of the following: surgical hysterectomy with bilateral oophorectomy; radiation-induced oophorectomy with last menses >1 year ago; chemotherapy-induced menopause with 1 year interval since last menses.
    10. Written, informed consent prior to the present study and to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient or by the parents/legal tutors at any time without prejudice.
    11. Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.

    15.TBR > 5
    1. HGG/DIPG istologicamente o radiologicamente confermati;
    2. Malattia misurabile (almeno una lesione oggettivamente misurabile bi-dimensionalmente >1.0 cm nel suo diametro massimo) con RM;
    3. KPS = 60;
    4. Aspettativa di vita maggiore di 3 mesi;
    5. Maschio o Femmina collaborativi di età compresa tra i 5 e i 18 anni;
    6. Funzione midollare normale definita come:
    a. Conteggio assoluto neutrofili = 1.5x109/L
    b. Conteggio piastrine = 150x109/L
    c. Emoglobina = 9 g/L
    7. Funzione epatica adeguata, definita come:
    a. AST/ALT = 2.5 x limite superiore di normalità (ULN) (o = 5.0 x ULN se presenti localizzazioni epatiche di malattia) bilirubina diretta = 1.5 ULN; funzione renale adeguata con creatinina sierica = 1.5 mg/dl o clearance della creatinina > 60 ml/min
    b. Valori normali di ALP
    c. Parametri di coagulazione normali
    8. Funzione renale adeguata con creatinina sierica = 1.5 mg/dl o clearance della creatinina > 60 ml/min;
    9. Gonadotropina corionica umana negativa (hCG) nelle ragazze potenzialmente in gravidanza. I pazienti di entrambi i sessi con attività sessuale attiva useranno metodi a scopo anticoncezionale (e.s. metodi barriera con spermicidi, contraccettivi orali o parenterali e/o dispositivi intrauterini) durante ‘intera durata dello studio e per i 6 mesi successivi al termine della somministrazione finale di 64CuCl2. Nota: la sterilità (nelle pazienti di sesso femminile) deve essere confermata nelle cartelle mediche e può essere definita con le seguenti: istero-annessiectomia bilaterale chirurgica, ovariectomia radio-indotta con ultime mestruazioni > 1 anno; menopausa indotta da chemioterapia con un intervallo di 1 anno dalle ultime mestruazioni;
    10. Consenso informato scritto precedente ad ogni procedura specifica dello studio. Procedure di screening, con la conoscenza che il consenso potrebbe essere ritirato dal paziente o dai parenti/tutori legali in qualsiasi momento senza pregiudizio;
    11. Capacità di comprendere le richieste del protocollo e abilita di rispettare le procedure del protocollo di studio.
    E.4Principal exclusion criteria
    1. Histology other than High Grade Glioma.
    2. Contraindication to MRI with gadolinium.
    3. Copper metabolic disorders (i.e. known Wilson disease or Menkes disease).
    4. Patients who have not recovered from adverse events Grade > 1 due to diagnostic injection of Cuprymina.
    5. Pregnant or breastfeeding women.
    6.Sexually active male and female patients of childbearing potential without use of an effective method of birth control.
    7.Known HIV disease or acquired immunodeficiency syndrome-related illness or active hepatitis B or C infection.
    8. Uncontrolled Diabetes
    1. Istologia e/o imaging RM non compatibile con HGG/DIPG;
    2. Controindicazioni alla RM con gadolinio;
    3. Disordini metabolici del rame (e.s. diagnosi di malattia di Wilson o di Menkes);
    4. Pazienti con malattia intercorrente non controllata: infezione attiva o in corso, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, aritmia cardiaca o malattie psichiatriche/situazioni sociali che limiterebbero la conformità ai requisiti dello studio;
    5. Donne in gravidanza o in allattamento;
    6. Pazienti di entrambi i sessi sessualmente attivi che non utilizzano dispositivi anticoncezionali;
    7. Pazienti HIV positivi o con sindrome da immunodeficienza acquisita o epatite B o C attiva;
    8. Diabete non controllato.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the diagnostic accuracy of 64CuCl2-PET / CT in identifying HGG and DIPG
    Correlate the intensity of 64CuCl2 with tumor aggressiveness
    Evaluate the prognostic impact of 64CuCl2 (i.e. the ability to identify patients at increased risk of disease progression)
    Valutare l’accuratezza diagnostica della 64CuCl2- PET/CT nell’identificare gli HGG e i DIPG;
    Correlare l’intensità del 64CuCl2 con l’aggressività tumorale;
    Valutare l’impatto prognostico del 64CuCl2 (i.e. la capacità di identificare i pazienti a maggior rischio di progressione di malattia)
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 months
    16 mesi
    E.5.2Secondary end point(s)
    To study biodistribution, kinetics and dosimetry based on MIRD method of 64CuCl2 both in the tumor lesion and in the organs
    Evaluating the Tumor to Background ratio (TBR) of 64CuCl2 in function of time
    Evaluate the safety and tolerance of 64CuCl2 and possible occurrence of adverse events
    Studiare la biodistribuzione, la cinetica e la dosimetria basata sul metodo MIRD del 64CuCl2 sia nella lesione tumorale sia negli organi;
    Valutare l’andamento temporale del Tumour to Background ratio (TBR) del 64CuCl2;
    Valutare la sicurezza e la tolleranza del 64CuCl2 e l’eventuale insorgenza di eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 months
    16 mesi
    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 Yes
    E.6.13.1Other scope of the trial description
    to assess whether 64CuCI2 could eventually influence patient management
    impatto clinico eventuale
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    studio pilota di efficacia diagnostica nello stesso gurppo di pazienti
    pilot study of diagnostic accuracy
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number 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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 3
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    The patient will continue to be followed by the medical staff as before participating in the study.
    il paziente continuerà ad essere seguito dallo staff medico presso cui è in cura come prima della partecipazione allo studio.
    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 Decision2019-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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