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    Summary
    EudraCT Number:2021-003374-30
    Sponsor's Protocol Code Number:SONIC-ALA
    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:2021-10-19
    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 number2021-003374-30
    A.3Full title of the trial
    A pilot study to Evaluate the Safety and Feasibility of Sonodynamic Therapy Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas.
    Studio Pilota per valutare la sicurezza e la fattibilità della terapia sonodinamica usando il sistema a ultrasuoni focalizzati ExAblate con guida di risonanza nel trattamento dei Glioblastomi Cerebrali.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sonodynamic therapy using Focused Ultrasound and 5-ala in the treatment of glioblastomas.
    Terapia sonodinamica mediante ultrasuoni focalizzati e 5 Ala nei glioblastomi.
    A.3.2Name or abbreviated title of the trial where available
    SONIC-ALA
    SONIC-ALA
    A.4.1Sponsor's protocol code numberSONIC-ALA
    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 supportFocused Ultrasound Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Istituto Neurologico Carlo Besta
    B.5.2Functional name of contact pointDipartimento Ricerca e Sviluppo Cli
    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.5.6E-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 GLIOLAN
    D.2.1.1.2Name of the Marketing Authorisation holderMedac Gesellschaft für klinische Spezialpräparate mbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGLIOLAN
    D.3.2Product code [EU/1/07/413/001-003]
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNacido 5-aminolevulinico
    D.3.9.1CAS number 5451-09-2
    D.3.9.2Current sponsor codeEU/1/07/413/001
    D.3.9.3Other descriptive name5-ALA
    D.3.9.4EV Substance CodeINN-5-aminolevu
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 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
    IV degree lobar glioblastoma with a diameter of less than 5 cm.
    glioblastoma lobare di IV grado con diametro inferiore a 5 cm.
    E.1.1.1Medical condition in easily understood language
    High-grade malignant tumor
    Tumore maligno di alto grado
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The goal of this prospective, non-randomized, single-arm study is to evaluate the safety and feasibility of sonodynamic therapy with 5-aminolevulinic acid in patients with newly diagnosed cerebral
    glioblastomas using the ExAblate Model 4000 Type-2 “Neuro-System”.
    L'obiettivo di questo studio prospettico, non randomizzato, a braccio singolo è valutare la sicurezza e la fattibilità della terapia sonodinamica con acido 5-aminolevulinico in pazienti con nuova diagnosi cerebrale di glioblastomi utilizzando il “Neuro-System” ExAblate Modello 4000 Tipo-2.
    E.2.2Secondary objectives of the trial
    Efficacy of the treatment, the following data will be collected for each subject:
    - Overall tumor volume (for images)
    - Immunohistochemical staining dedicated to the detection of cellular apoptosis and
    necrosis, as well as angiogenesis and inflammation
    Efficacia del trattamento, per ogni soggetto verranno raccolti i seguenti dati:
    - Volume tumorale complessivo (per immagini)
    - Colorazione immunoistochimica dedicata al rilevamento dell'apoptosi cellulare e della
    necrosi, nonché dell'angiogenesi e dell'infiammazione
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criteria Inclusion: CH patients
    - age between 18-60 years;
    - both genders;
    - diagnosis of grade IV lobar glioblastoma with a diameter of less than 5 cm;
    - diagnosis confirmed with magnetic resonance examination;
    - no contraindication to the magnetic resonance examination;
    - no contraindications to surgery.
    Criteri Inclusione: pazienti CH
    - età compresa tra 18-60 anni;
    - entrambi i generi;
    - diagnosi di glioblastoma lobare di IV grado di diametro inferiore a 5 cm;
    - diagnosi confermata con esame di risonanza magnetica;
    - nessuna controindicazione all’esame di risonanza magnetica;
    - nessuna controindicazione all’intervento chirurgico.
    E.4Principal exclusion criteria
    Exclusion Criteria
    1. Brain glioblastoma presenting with the following characteristics:
    ¿ Brain edema and/or mass effect that causes midline shift of more than 10 mm
    ¿ Evidence of recent intracranial hemorrhage within the targeted tumor volume
    ¿ Calcifications in the focused ultrasound sonication path (system tools may not
    tailor the treatment around these calcifications)
    2. The sonication pathway to the tumor involves either:
    ¿ more than 30% of the skull area traversed by scars, scalp disorders (e.g. eczema),
    or atrophy of the scalp
    ¿ Clips, shunts, or other metallic implanted objects in the skull or the brain
    3. Cardiac disease or unstable hemodynamic status including:
    ¿ Documented myocardial infarction within six months of enrolment
    ¿ Unstable angina on medication
    ¿ Congestive heart failure
    ¿ Left ventricular ejection fraction < 50%
    ¿ Right-to-left, bidirectional, or transient right-to-left cardiac shunts
    ¿ History of a hemodynamically unstable cardiac arrythmia
    ¿ Cardiac pacemaker
    4. Severe hypertension
    5. Anti-coagulant therapy or medications known to increase risk of hemorrhage within
    washout period prior to treatment
    6. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor
    hemorrhage
    7. Abnormal level of platelets (<100000) or INR >1.3
    8. Cerebral or systemic vasculopathy
    9. Known allergy sensitivity or contraindications to gadolinium
    10. Contraindications to MRI such as non-MRI-compatible implanted devices
    14
    11. Subjects not fitting comfortably into the MRI scanner
    12. Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia
    13. Positive pregnancy test (for pre-menopausal women)
    14. Severely impaired renal function with estimated glomerular filtration rate
    <30mL/min/1.73m2 and/or on dyalisis
    15. Respiratory: chronic pulmonary disorders, e.g. severe emphysema, COPD, pulmonary
    vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
    16. Any illness or medical condition that in the investigator’s opinion precludes participation
    in this study
    17. Patients unable to sign a consent form
    Criteri di esclusione
    1. Glioblastoma cerebrale che si presenta con le seguenti caratteristiche:
    ¿ Edema cerebrale e/o effetto massa che causa uno spostamento della linea mediana superiore a 10 mm
    ¿ Evidenza di emorragia intracranica recente all'interno del volume del tumore mirato
    ¿ Calcificazioni nel percorso di sonicazione a ultrasuoni focalizzati (gli strumenti di sistema potrebbero non
    adattare il trattamento intorno a queste calcificazioni)
    2. La via di sonicazione al tumore coinvolge:
    ¿ più del 30% dell'area del cranio attraversata da cicatrici, disturbi del cuoio capelluto (es. eczema),
    o atrofia del cuoio capelluto
    ¿ Clip, shunt o altri oggetti metallici impiantati nel cranio o nel cervello
    3. Malattia cardiaca o stato emodinamico instabile, inclusi:
    ¿ Infarto miocardico documentato entro sei mesi dall'arruolamento
    ¿ Angina instabile con i farmaci
    ¿ Insufficienza cardiaca congestizia
    ¿ Frazione di eiezione ventricolare sinistra < 50%
    ¿ Shunt cardiaci da destra a sinistra, bidirezionali o transitori da destra a sinistra
    ¿ Storia di un'aritmia cardiaca emodinamicamente instabile
    ¿ Pacemaker cardiaco
    4. Ipertensione grave
    5. Terapia anticoagulante o farmaci noti per aumentare il rischio di emorragia all'interno
    periodo di washout prima del trattamento
    6. Storia di un disturbo emorragico, coagulopatia o con una storia di tumore spontaneo
    emorragia
    7. Livello anormale di piastrine (<100000) o INR >1.3
    8. Vasculopatia cerebrale o sistemica
    9. Sensibilità all'allergia nota o controindicazioni al gadolinio
    10. Controindicazioni alla risonanza magnetica come dispositivi impiantati non compatibili con la risonanza magnetica
    14
    11. Soggetti che non si adattano comodamente allo scanner MRI
    12. Difficoltà a rimanere supini e immobili fino a 4 ore nell'unità di risonanza magnetica o claustrofobia
    13. Test di gravidanza positivo (per donne in pre-menopausa)
    14. Funzione renale gravemente compromessa con velocità di filtrazione glomerulare stimata
    <30 ml/min/1,73 m2 e/o in dialisi
    15. Respiratorio: disturbi polmonari cronici, ad es. enfisema grave, BPCO, polmonare
    vasculite o altre cause di ridotta area della sezione trasversale vascolare polmonare.
    16. Qualsiasi malattia o condizione medica che, a giudizio dello sperimentatore, precluda la partecipazione
    in questo studio
    17. Pazienti che non sono in grado di firmare un modulo di consenso
    E.5 End points
    E.5.1Primary end point(s)
    safety
    sicurezza
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 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 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) 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 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.8.6 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 years1
    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 years1
    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) 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)
    follow up according to normal clinical practice
    follow up secondo normale pratica clinica
    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 Decision2021-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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