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    Summary
    EudraCT Number:2012-000513-36
    Sponsor's Protocol Code Number:VIRN2012
    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:2012-03-29
    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 number2012-000513-36
    A.3Full title of the trial
    Validation of the use of lymphography with green indocyanine in identifying the sentinel node in breast cancer
    Validazione dell’utilizzo del verde indocianina nell’identificazione del linfonodo sentinella nel carcinoma mammario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Validation of the use of green indocyanine in identifying the sentinel node in breast cancer
    Validazione dell’utilizzo del verde indocianina nell’identificazione del linfonodo sentinella nel carcinoma mammario
    A.4.1Sponsor's protocol code numberVIRN2012
    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 SponsorA.U.S.L. RIMINI
    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 supportAUSL Rimini
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAUSL Rimini
    B.5.2Functional name of contact pointRicerca e Innovazione
    B.5.3 Address:
    B.5.3.1Street Addressvia Coriano 38
    B.5.3.2Town/ cityRimini
    B.5.3.3Post code47921
    B.5.3.4CountryItaly
    B.5.4Telephone number0541707813
    B.5.5Fax number0541707751
    B.5.6E-mailipanzini@auslrn.net
    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 VERDE INDOC.PULS.*INIET 5FL25M
    D.2.1.1.2Name of the Marketing Authorisation holderPULSION MEDICAL SYSTEMS AG
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINDOCYANINE GREEN
    D.3.9.1CAS number 3599-32-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB14208MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    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
    WOMAN BREAST CANCER
    CANCRO DELLA MAMMELLA DELLA DONNA
    E.1.1.1Medical condition in easily understood language
    WOMAN BREAST CANCER
    CANCRO DELLA MAMMELLA DELLA DONNA
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Validation of the the fluorescence lymphography with green indocyanine by comparing direct inter and intra-patients with the gold standard method the radio colloid
    Validazione della nuova metodica, la linfografia a fluorescenza, mediante il confronto diretto inter ed intra-pazienti con il metodo gold standard, il radio colloide.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥ 18
    Histologically or cytologically confirmed diagnosis of breast cancer
    Early Breast cancer than or equal to 3 cm in diameter;
    Clinically negative axilla;
    Signature of Informed Consent.
    Età ≥ 18
    Diagnosi citologicamente o istologicamente accertata di carcinoma mammario
    Tumore Mammario primitivo inferiore o uguale a 3 cm di diametro;
    Ascella clinicamente negativa;
    Firma del Consenso Informato.
    E.4Principal exclusion criteria
    Hypersensitivity / allergy known to ICG, sodium iodide or iodine;
    hyperthyroidism;
    Thyroid cancer;
    Patients who are pregnant and / or lactation;
    Patients who are taking medicines that affect liver function;
    Patients with renal insufficiency;
    Patients who are taking drugs that may alter the absorption of green indocyanine
    Patients with psychiatric illness or any illness that would impair the ability to provide informed consent for participation in this study.
    Ipersensibilità/allergia nota al ICG, allo ioduro di sodio o allo iodio;
    Ipertiroidismo;
    Neoplasia tiroidea;
    Pazienti in gravidanza e/o allattamento;
    Pazienti che stanno assumendo medicinali che influenzano la funzionalità epatica;
    Pazienti con insufficienza renale;
    Pazienti che stanno assumendo farmaci che possono alterare l’assorbimento del Verde Indocianina;
    Pazienti con malattie psichiatriche o con qualsiasi malattia, che compromettano la capacità di fornire il proprio consenso informato per la partecipazione a questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The study aims is to demonstrate the equivalence of the two methods. It is assumed that the radioactive tracer (Gold Standard) captures at least 97% of the lymph nodes, the percentage of discrepancy between the two tests is 6% and sets the margin of equivalence of the difference in performance between the two methods to = 5% .
    Lo studio si prefigge di dimostrare l’equivalenza delle due metodiche. Si assume che il tracciante radioattivo (Gold Standard) capti almeno il 97% dei linfonodi, che la percentuale di discordanza tra i due test sia del 6% e si fissa il margine di equivalenza della differenza delle prestazioni tra le due metodiche a d=5%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 day
    1 giorno
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months0
    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: 200
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state200
    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)
    surgical and oncologic follow-up
    follow up chirurgico ed oncologico di routine
    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 Decision2012-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
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