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    Summary
    EudraCT Number:2020-000393-20
    Sponsor's Protocol Code Number:AX-CES1.2020
    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:2020-10-22
    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 number2020-000393-20
    A.3Full title of the trial
    USE OF SULFUR HEXAFLUORIDE MICROBUBBLES IN INTRAOPERATIVE SURGICAL EVALUATION OF AXILLARY LYMPH NODES IN LOCO-REGIONAL ANESTHESIA BREAST SURGERY: COMPARISON WITH THE TRADITIONAL METHODICAL. PRELIMINARY STUDY AX-CES 1.2020
    UTILIZZO DELLE MICROBOLLE DI ESAFLUORURO DI ZOLFO NELLA VALUTAZIONE CHIRURGICA INTRAOPERATORIA DEI LINFONODI ASCELLARI NELLA CHIRURGIA MAMMARIA IN ANESTESIA LOCO-REGIONALE: CONFRONTO CON LA METODICA TRADIZIONALE. STUDIO PRELIMINARE AX-CES 1.2020
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    USE OF SULFUR HEXAFLUORIDE MICROBUBBLES IN INTRAOPERATIVE SURGICAL EVALUATION OF AXILLARY LYMPH NODES IN LOCAL ANESTHESIA BREAST SURGERY IN COMPARISON WITH THE TRADITIONAL METHODICAL.
    UTILIZZO DELLE MICROBOLLE DI ESAFLUORURO DI ZOLFO NELLA VALUTAZIONE CHIRURGICA INTRAOPERATORIA DEI LINFONODI ASCELLARI NELLA CHIRURGIA MAMMARIA IN ANESTESIA LOCALE IN CONFRONTO CON LA METODICA TRADIZIONALE
    A.3.2Name or abbreviated title of the trial where available
    AX-CES 1.2020
    AX-CES 1.2020
    A.4.1Sponsor's protocol code numberAX-CES1.2020
    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 SponsorDIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA
    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 supportDipartimento Scienze Chirurgiche, Università degli Studi di Roma: Tor Vergata; via Montpellier 1 – 00133 Roma.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLink Neuroscience and Health Care srl - L.N.Age srl
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressVia Luigi Rizzo 62
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00136
    B.5.3.4CountryItaly
    B.5.6E-mailinfo@lnage.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 SONOVUE - 8 MCG/ML POLVERE E SOLVENTE PER DISPERSIONE INIETTABILE 1 FLACONCINO (VETRO) +1 SIRINGA PRERIEMPITA (PLASTICA) 5 ML + 1 ADATTATORE MINI SPIKE USO EV
    D.2.1.1.2Name of the Marketing Authorisation holderBRACCO INTERNATIONAL B.V.
    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.3.1Product nameSonoVue
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeN/A
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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
    Breast Cancer
    Cancro della mammella
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Tumore alla mammella
    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 LLT
    E.1.2Classification code 10072873
    E.1.2Term Sentinel lymph node mapping
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the validity of CEUS ultrasound with subcutaneous means of contrast SonoVue, compared to other methods and examinations already consolidated in clinical practice.
    Dimostrare la validità dell’ecografia CEUS con mezzo di contrasto sottocutanea Sonovue, rispetto alle altre metodiche ed esami già consolidati nella pratica clinica.
    E.2.2Secondary objectives of the trial
    - Opinions and pain of patients at the end of the CEUS procedure, of all possible complications highlighted in the literature and not present in the literature after the CEUS procedure and after surgery.
    - Procedure times of percutaneous procedure, all-out surgery, sentinel lymph node biopsy and CEUS procedure.
    - Costs of sentinel lymph node procedure and CEUS guided percutaneous procedure.
    - Opinioni e il dolore delle pazienti al termine della procedura CEUS, di tutte le possibili complicanze evidenziate in letteratura e non presenti in letteratura dopo la procedura CEUS e dopo l’intervento chirurgico.
    - Tempi di procedura della procedura percutanea, dell’intervento chirurgico in toto, della biopsia del linfonodo sentinella e della procedura CEUS.
    - Costi della procedura del linfonodo sentinella e della procedura percutanea CEUS guidata.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient diagnosed with ductal breast cancer infiltrated T 0-2 N0 M0 to which was proposed after discussion at the multidisciplinary meeting an upfront surgery and sentinel lymph node biopsy.
    - age >18
    - Weight 40-85 kg
    - Infiltrating neoplasia
    - No evidence of clinically suspicious axillary lymph nodes
    • Paziente con diagnosi di neoplasia mammaria duttale infiltrate T 0-2 N0 M0 a cui è stato proposto dopo discussione presso il meeting multidisciplinare un intervento chirurgico upfront e biopsia del linfonodo sentinella.
    • età >18 anni
    • peso 40-85 kg
    • Neoplasia infiltrante
    • Non evidenza di linfonodi ascellari sospetti clinicamente
    E.4Principal exclusion criteria
    - Patients with remote metastases
    - Patients undergoing Neonatal chemotherapy or previously undergoing chest radiotherapy
    - Patients undergoing homolateral breast QSE surgery
    - Patients undergoing surgery in the homolateral armpit region
    - Patients who have not expressed, or are unable to do so, informed consent to the study
    - Counter-indications of postoperative radiotherapy
    - Personal history of allergy to lidocaine, ultrasound contrast, scintigraphic or vital dyes such as methylene blue
    - Patient with infection or cellulite of the breast region, upper limb and chest treatment site
    - Ongoing pregnancy
    - Patients who have previously expressed a desire to be followed in the post-treatment multidisciplinary follow-up by another facility
    - Patients with any other contraindication to CEUS or lymphatic scintigraphy
    • Pazienti con metastasi a distanza
    • Pazienti sottoposte a Chemioterapia Neoadivante o sottoposte in precedenza a radioterapia toracica
    • Pazienti sottoposte a chirurgia del QSE della mammella omolaterale
    • Pazienti sottoposte a chirurgia della regione ascellare omolaterale
    • Pazienti che non hanno espresso, o non sono in grado di farlo, il consenso informato allo studio
    • controindicazioni alla radioterapia postoperatoria
    • Anamnesi personale di allergia alla lidocaina, al mezzo di contrasto ecografico, scintigrafico o a coloranti vitali quali blu di metilene
    • paziente con infezione o cellulite della regione mammaria, dell’arto superiore e del torace sede di trattamento
    • gravidanza in corso
    • Pazienti che hanno espresso precedentemente il desiderio di essere seguite nel follow up post trattamento multidisciplinare da parte di un’altra struttura
    • Pazienti con qualsiasi altra controindicazione alla CEUS o alla scintigrafia linfatica
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of this study is to assess the number of lymph nodes highlighted by the standard lymphoscintigraphic tracer procedure combined with the use of the ultrasound tracer and the rate of agreement on the number of sentinel lymph nodes identified with the traditional procedure with respect to the procedure by means of ultrasound contrast.
    L’end point primario di questo studio è valutare il numero di linfonodi evidenziati mediante la procedura standard del tracciante linfoscintigrafico unita all’utilizzo del tracciante ecografico ed il tasso di concordanza del numero di linfonodi sentinella individuati con la procedura tradizionale rispetto alla procedura mediante mezzo di contrasto ecografico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the ultrasound
    Al termine dell'ecografia
    E.5.2Secondary end point(s)
    - Questionnaires
    - Measure of time
    - Average costs will be calculated on the average of the above times
    - Questionari
    - Misura dei tempi
    - I costi medi verranno calcolati in funzione della media dei tempi suddetti
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the ultrasound and surgery
    Al termine dell'ecografia e dell'intervento chirurgico
    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 No
    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) 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) Yes
    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
    30 days after surgery
    30 giorni dopo l'intervento chirurgico
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 20
    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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Treatment for subjects at the end of their participation in the study will be assessed by the investigator
    Il trattamento per i soggetti al termine della loro partecipazione allo studio sarà valutato dallo sperimentatore
    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 Decision2020-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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