Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-002527-18
    Sponsor's Protocol Code Number:FluoGlio2011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-09
    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 number2011-002527-18
    A.3Full title of the trial
    Phase II, open label, monocentric, uncontrolled, non randomized clinical trial on Sodium Fluorescein for Surgery of High Grade Gliomas.
    Studio clinico di Fase II, in aperto, monocentrico, non controllato, non randomizzato, sulla Fluoresceina Sodica nella Chirurgia dei Gliomi di alto Grado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial on the use of Sodium Fluorescein for the surgical removal of High Grade Gliomas.
    Studio Clinico sulla Fluoresceina Sodica per l'asportazione chirurgica dei Gliomi di alto grado.
    A.3.2Name or abbreviated title of the trial where available
    FluoGlio
    FluoGlio
    A.4.1Sponsor's protocol code numberFluoGlio2011
    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 SponsorISTITUTO 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 supportFondazione IRCCS Istituto Neurologico Carlo Besta
    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 pointServizio Ricerca e Sviluppo Clinico
    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 number0223942321
    B.5.5Fax number0223943568
    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 Yes
    D.2.1.1.1Trade name FLUORESCEINA SODICA MON*IV 10F
    D.2.1.1.2Name of the Marketing Authorisation holderMONICO SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNFLUORESCEINA SODICA 1 g 5 ml (20%)
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number15
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeagente fluorescente
    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
    Intracranial high grade gliomas
    Gliomi cerebrali di alto grado
    E.1.1.1Medical condition in easily understood language
    Intracranial malignant glial tumors
    Tumori cerebrali maligni della serie gliale
    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
    To evaluate the safety of preoperative intravenous injection of sodium fluorescein during surgery for high grade gliomas and to evaluate fluorescein capability to improve intraoperative visualization of tumor’s margins thus allowing a complete tumor resection.
    Obiettivo dello studio è valutare la sicurezza dell’iniezione endovenosa pre-operatoria di fluoresceina sodica nella chirurgia dei gliomi di alto grado e di ottenere indicazioni sulla capacità di migliorare la visualizzazione dei margini tumorali ottenendo una resezione chirurgica completa della neoplasia.
    E.2.2Secondary objectives of the trial
    To analyze the Progression Free Survival (PFS) at 6 and 12 months, the overall survival (OS) and the volume of residual tumor in cases of partial resection in a population of patients affected by high grade gliomas treated with image-guided surgical tumor excision plus intraoperative tumor visualization with sodium fluorescein, followed by postoperative concomitant chemotherapy and radiotherapy. Moreover, to evaluate the possible presence and seriousness of new postoperative neurological deficits.
    In pazienti affetti da glioma di alto grado trattati con resezione chirurgica guidata da immagini e visualizzazione tumorale intraoperatoria con fluoresceina sodica, seguita da chemioterapia e radioterapia concomitanti postoperatorie, analizzare l’intervallo libero da malattia (PFS) a 6 e 12 mesi dall’intervento chirurgico, la sopravvivenza globale e il volume tumorale residuo nei casi di resezione parziale. Inoltre, valutare l’eventuale presenza e gravità di nuovi deficit neurologici postoperatori.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:1.0
    Date:2011/06/01
    Title:Ancillary study for the analisys of genes and cells of the immune system in high grade gliomas.
    Objectives:Analisys of genes (IDH1, MGMT ed EGFRvIII), mutations (codeletation 1p/19q), angiogenic and inflammatory molecules (VEGF e TGFbeta) and cells of the immune system (lynthocytes and NK)in enrolled patients.

    OTHER SUBSTUDIES:
    Accuracy of fluorescein in identification of high grade gliomas. vers 1.0 1.06.11 Objective: to evaluate fluorescein sensitivity and specificity in the identification of tumoral tissue.

    FARMACOGENETICA:
    Vers:1.0
    Data:2011/06/01
    Titolo:Studio ancillare per l'analisi di geni e di cellule del sistema immunitario nei gliomi maligni.
    Obiettivi:(Analisi di geni (IDH1, MGMT ed EGFRvIII), mutazioni (codelezione 1p/19q), molecole angiogeniche ed infiammatorie (VEGF e TGFbeta) e cellule del sistema immunitario (linfotici e NK) nei pazienti arruolati.

    ALTRI SOTTOSTUDI:
    Accuratezza della fluoresceina nell’identificare i gliomi maligni vers. 1.0 del 1.06.11 Obiettivi: valutare sensibilità e specificità della fluorescina nell'identificare il tessuto tumorale.

    E.3Principal inclusion criteria
    a)Patients, both males and females, with an age between 18 and 75 years. b)Patients affected by probable first diagnosed high grade glioma, as suggested by a brain MR with and without intravenous paramagnetic contrast administration performed within 14 days before the surgical procedure. c)Patients considered eligible for complete surgical tumor removal. d)Patients undergone preoperative volumetric brain MR with intravenous paramagnetic contrast administration for neuronavigation. e)Preoperative KPS (Karnofsky performance scale) > 60.
    a)Pazienti di entrambi i sessi con età compresa tra i 18 e 75 anni. b)Pazienti affetti da sospetto glioma di alto grado di prima diagnosi, come suggerito da una RM encefalo senza e con mdc eseguita entro 14 giorni prima dell’intervento. c)Pazienti giudicati idonei ad intervento chirurgico di exeresi potenzialmente completa della neoplasia. d)Pazienti sottoposti a RM volumetrica con mdc pre-operatoria per neuro navigazione. e)KPS (Karnofsky performance scale) &gt; 60.
    E.4Principal exclusion criteria
    a)Tumors arising from basal ganglia, infratentorial, arising in the midline, multifocal. b)Tumors with wide non-contrast enhancing area suggesting low grade gliomas with secondary malignant transformation. c)Medical reasons that make the patient unsuitable to undergo brain MR. d)Cognitive or speech impairment that make the patient unable to give his/her consent. e)Previous malignant tumors in any other localizations still under therapy or anyway considered not cured. f)Known contrast allergy or previous anaphylactic shock. g)Renal failure. h)Hepatic failure.
    a)Tumori a partenza dei gangli della base, sottotentoriali, a partenza dalla linea mediana, multicentrici. b)Tumori con estesa area non captante m.d.c. che suggeriscono gliomi di basso grado con secondaria trasformazione maligna. c)Impossibilità ad eseguire RM per ragioni mediche. d)Impossibilità a dare il consenso per deficit fasico o cognitivo. f)Pregressi tumori maligni in altre localizzazioni in corso di terapia o comunque non considerati guariti. e)Allergia nota a mezzi di contrasto e/o pregressi shock anafilattici. f)Insufficienza renale. g)Insufficienza epatica.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patient affected by istopathologic confirmed high grade glioma without residual paramagnetic contrast enhancing at early (within 72 hours) postoperative MR (100% complete resection).
    La proporzione di pazienti affetti da glioma di alto grado confermato istologicamente senza residuo captante mezzo di contrasto alla RM postoperatoria precoce, entro 72 ore dall’intervento (resezione completa=100%).
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 hours
    72 ore
    E.5.2Secondary end point(s)
    a)PFS (progression free survival) at 6 and 12 months. b)Volume of residual tumor at postoperative MR in cases of partial resection. c)OS (overall survival). d)Presence and seriousness of new postoperative neurological deficits. e)Toxicity.
    a)PFS (progression free survival) a 6 e 12 mesi. b)Volume residuo tumorale alla RM postoperatoria nei casi di resezione parziale. c)OS (overall survival). d)Presenza e gravità di nuovi deficit neurologici postoperatori. e)Tossicità.
    E.5.2.1Timepoint(s) of evaluation of this end point
    42 months
    42 mesi
    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 No
    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) 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 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 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 months42
    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.1.1Number 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: 11
    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 2012-02-09. 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 state46
    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)
    To Continue with clinical and radiological follow-up; in case of recurrence, the treatment will be decided according to physician decisions.
    Mantenimento follow-up clinico e radiologico; in caso di recidiva, proseguire il trattamento secondo il parere dei medici specialisti
    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 Decision2011-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 30 21:37:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA