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    Summary
    EudraCT Number:2015-000679-28
    Sponsor's Protocol Code Number:FAZA-gliomi
    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:2021-06-04
    Trial results View 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 number2015-000679-28
    A.3Full title of the trial
    Prognostic value of 18F-FAZA PET/CT in high grade glioma: comparison with MRI and correlation with hypoxia biomarkers.
    Ruolo prognostico della PET/TC con 18F-FAZA nei gliomi ad alto grado: confronto con la risonanza magnetica e correlazione con i biomarcatori di ipossia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of diagnostic imaging in the study of gliomas.
    Ruolo della diagnostica per immagini nello studio dei gliomi.
    A.3.2Name or abbreviated title of the trial where available
    FAZA-gliomas
    FAZA-gliomi
    A.4.1Sponsor's protocol code numberFAZA-gliomi
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS OSPEDALE SAN RAFFAELE
    B.5.2Functional name of contact pointMEDICINA NUCLEARE
    B.5.3 Address:
    B.5.3.1Street AddressVIA OLGETTINA 60
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number02-26436117
    B.5.5Fax number02-26432717
    B.5.6E-mailpicchio.maria@hsr.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 nameFAZA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    Patients with high-grade glioma (III-IV).
    Pazienti affetti da glioma ad alto grado (III-IV).
    E.1.1.1Medical condition in easily understood language
    Patients with glioma.
    Pazienti affetti da glioma.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10018339
    E.1.2Term Gliomas benign
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To define the role of PET/CT with 18F-FAZA as a guide to biopsy, to predict patient outcomes, to define the correlation between spatial pseudoprogressione disease / radiation necrosis and hypoxia and to plan radiotherapy treatment in patients with high-grade gliomas.
    Definire il ruolo della PET/TC con 18F-FAZA come guida alla biopsia, per predire l’outcome dei pazienti, per definire la concordanza spaziale tra pseudoprogressione di malattia/radionecrosi ed ipossia e per pianificare il trattamento radioterapico personalizzato in pazienti con gliomi ad alto grado.
    E.2.2Secondary objectives of the trial
    Correlation between MRI and PET data with histopathological data.
    Correlazione tra dati PET e RM con dati istopatologici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - adult patients
    - MRI suggestive of the presence of high-grade glioma
    - indication of the performance of stereotactic biopsy
    - patients are able to understand the study and release their consent
    - pazienti adulti
    - imaging RM suggestivo per presenza di glioma ad alto grado
    - indicazione all’esecuzione di biopsia stereotattica
    - pazienti in grado di comprendere lo studio e rilasciare il loro consenso
    E.4Principal exclusion criteria
    - pregnancy and/or breastfeeding
    - patients <18years
    - inability to perform stereotactic biopsy
    - gravidanza e/o allattamento
    - pazienti <18anni
    - impossibilità ad essere sottoposti a biopsia stereotattica
    E.5 End points
    E.5.1Primary end point(s)
    visual and semiquantitative evaluation of tracer FAZA
    valutazione visiva e semiquantitativa del tracciante FAZA
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 DAY
    1 GIORNO
    E.5.2Secondary end point(s)
    visualize the standard treatment planning based on MRI images with treatment guided by PET images
    visualizzare la pianificazione del trattamento standard basato sulle immagini di risonanza magnetica con trattamento guidato da immagini PET
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 DAY
    1 GIORNO
    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 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.8.2.4Number 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.8.5.1Number of sites anticipated in the EEA1
    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 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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 10
    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 2021-06-04. 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    AT THE END OF CLINICAL TRIAL PATIENTS WILL CONTINUE CLINICAL PROCEDURE ALREADY PROVIDED FOR THEIR PATHOLOGY.
    AL TERMINE DELLA SPERIMENTAZIONE CLINICA I PAZIENTI PROSEGUIRANNO L’ITER CLINICO GIA’ PREVISTO PER LA LORO PATOLOGIA.
    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 Decision2015-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
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