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    Summary
    EudraCT Number:2012-005398-30
    Sponsor's Protocol Code Number:dopa
    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:2013-01-11
    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 number2012-005398-30
    A.3Full title of the trial
    Diagnostic efficacy and prognostic method [18F] DOPA-PET/CT in
    study of neuroblastoma: comparison with 123I-MIBG scintigraphy
    Efficacia diagnostica e prognostica della metodica [18F]DOPA-PET/CT nello studio del Neuroblastoma: confronto con scintigrafia 123I-MIBG
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic efficacy and prognostic method [18F] DOPA-PET/CT in
    study of neuroblastoma: comparison with 123I-MIBG scintigraphy
    Efficacia diagnostica e prognostica della metodica [18F]DOPA-PET/CT nello
    studio del Neuroblastoma: confronto con scintigrafia 123I-MIBG
    A.3.2Name or abbreviated title of the trial where available
    dopa
    dopa
    A.4.1Sponsor's protocol code numberdopa
    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 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 supporte.o. ospedali galliera
    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.5.5Fax number0105634534
    B.5.6E-mailarnoldo.piccardo@galliera.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 isodopa
    D.2.1.1.2Name of the Marketing Authorisation holderIASON
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive name6-[18F]fluoro-L-dopa
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    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.IMP: 2
    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 GUANIDINA
    D.2.1.1.2Name of the Marketing Authorisation holderMALLINCKRODT
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 77679-27-7
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/kg becquerel(s)/kilogram
    D.3.10.2Concentration typeup to
    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
    patients wiht NB onset with high probability to return in stages 3 and 4 of the disease on the basis of the ultrasound images or TC. May also be included with the two-stage amplification of N-MYC
    pazienti affetti da NB all'esordio con elevata probabilità di rientrare nello stadio 3 e 4 della malattia sulla base delle immagini ecografiche o TC. Potranno essere inclusi anche gli stadi 2 con amplificazione del N-MYC
    E.1.1.1Medical condition in easily understood language
    patients wiht NB onset with high probability to return in stages 3 and 4 of the disease on the basis of the ultrasound images or TC
    pazienti affetti da NB all'esordio con elevata probabilità di rientrare nello stadio 3 e 4 della malattia sulla base delle immagini ecografiche o TC
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    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
    check the diagnostic accuracy of 18F-DOPA-PET/TC compared with scintigraphy with 123I-MIBG during the staging of disease in patients with NB
    verificare l’accuratezza diagnostica della 18F-DOPA-PET/TC rispetto alla scintigrafia con 123I-MIBG nella fase di stadiazione di malattia in pazienti affetti da NB
    E.2.2Secondary objectives of the trial
    18F-DOPA-PET/TC verify the non-inferiority compared to 123I-MIBG scintigraphy in predicting prognosis and evaluation of response to therapy and in predicting prognosis
    verificare la non inferiorità della 18F-DOPA-PET/TC rispetto alla scintigrafia con 123I-MIBG nella predizione prognostica e nella valutazione della risposta alla terapia e nella predizione prognostica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 12 months <18 years
    - Patients suffering from NB onset with high probability to return in stages 3 and 4 of the disease on the basis of
    ultrasound or CT images. May also be included with the two-stage amplification of N-MYC
    - Histological diagnosis of NB
    - No previous chemotherapy lines with the exception of steroid treatment
    - written informed consent
    - età &gt; 12 mesi &lt;18 anni
    - pazienti affetti da NB all'esordio con elevata probabilità di rientrare nello stadio 3 e 4 della malattia sulla base delle
    immagini ecografiche o TC. Potranno essere inclusi anche gli stadi 2 con amplificazione del N-MYC
    - diagnosi istologica di NB
    - non precedenti linee chemioterapiche ad esclusione del trattamento steroideo
    - Consenso informato scritto
    E.4Principal exclusion criteria
    - Comorbidity for other cancers
    - Hypersensitivity to the active substance or excipients in the radiopharmaceutical.
    - Any other medical condition at the discretion of the investigator.
    - comorbidità per altre neoplasie
    - nota ipersensibilità a principio attivo o eccipienti contenuti nel radiofarmaco.
    - ogni altra condizione medica a giudizio dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    check the diagnostic accuracy of 18F-DOPA-PET/TC compared with scintigraphy with 123I-MIBG during the staging of disease in patients with NB
    verificare l’accuratezza diagnostica della 18F-DOPA-PET/TC rispetto alla scintigrafia con 123I-MIBG nella fase di stadiazione di malattia in pazienti affetti da NB
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 months
    48 mesi
    E.5.2Secondary end point(s)
    18F-DOPA-PET/TC verify the non-inferiority compared to 123I-MIBG scintigraphy in predicting prognosis and evaluation of response to therapy and in predicting prognosis
    verificare la non inferiorità della 18F-DOPA-PET/TC rispetto alla scintigrafia con 123I-MIBG nella predizione prognostica e nella valutazione della risposta alla terapia e nella predizione prognostica
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 months
    48 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    altra metodica diagnostica
    other strumental exam
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    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
    LVLS
    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 months48
    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 Yes
    F.1.1Number of subjects for this age range: 40
    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: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    minor
    minori
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Follow-up clinical and strumental
    Follow-up clinico e strumentale
    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 Decision2013-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-28
    P. End of Trial
    P.End of Trial StatusOngoing
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