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    Summary
    EudraCT Number:2011-002542-12
    Sponsor's Protocol Code Number:IEOS629/411
    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:2012-08-08
    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 number2011-002542-12
    A.3Full title of the trial
    Lymphatic mapping in oropharyngeal neoplasms: comparison between Dynamic Lymphoscintigrafy and Fluorescence Lymphografy using indocyanine green dye (ICG). Validation study.
    Mapping linfatico nelle neoplasie oro-faringee: integrazione fra Linfoscintigrafia Dinamica e Linfografia a Fluorescenza con verde indocianina (ICG). Studio di validazione del metodo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of possible nech metastasis of oral cancer
    Studio delle possibili sedi di metastasi linfonodali al collo da tumori della bocca
    A.4.1Sponsor's protocol code numberIEOS629/411
    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 EUROPEO DI ONCOLOGIA
    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 supportIstituto Europeo Oncologia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo Oncologia
    B.5.2Functional name of contact pointUfficio studi clinici
    B.5.3 Address:
    B.5.3.1Street Addressvia Ramusio 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number02 57 48 98 48
    B.5.5Fax number02 57 48 97 81
    B.5.6E-mailufficio.studiclinici@ieo.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 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 Powder for solution for injection
    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.3.9.4EV 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 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 typediagnostici
    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
    - Epithelial Carcinoma of the oral cavity and oropharynx
    - Carcinoma epiteliale del cavo orale e dell’orofaringe
    E.1.1.1Medical condition in easily understood language
    Oral cancer
    Carcinoma della bocca
    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 PT
    E.1.2Classification code 10034819
    E.1.2Term Pharyngeal cancer stage unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024534
    E.1.2Term Lip and/or oral cavity cancer NOS
    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 new method, the fluorescence lymphography, by direct comparison with the gold standard method, the radio colloid.
    Validazione della nuova metodica, la linfografia a fluorescenza, mediante il confronto diretto 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
    Male e Female of age ≥ 18 years old. Histological confirmed diagnosis of epithelial tumors of the oral cavity. Primary tumor cT4 candidate to major surgery with cervical access. Absence of clinically positive lymph nodes. Absence of previous treatments. Signed Informed Consent.
    Uomini e donne di eta' ≥ 18 anni. Diagnosi istologicamente accertata di neoplasia epiteliale del cavo orale. Tumore primitivo cT4 candidato a chirurgia complessa con accesso cervicale. Assenza di linfonodi clinicamente positivi. Assenza di pregressi trattamenti. Firma del Consenso Informato.
    E.4Principal exclusion criteria
    Hypersensitivity / known allergy to ICG, sodium iodide or iodine; Hyperthyroidism; Thyroid carcinoma; Pregnancy and / or lactation; Taking drugs that affect liver function; Renal failure; Taking medications that can alter the absorption of indocyanine-green; Psychiatric disorders or any disease that compromises the ability to provide informed consent for participation in this study.
    Ipersensibilita'/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 funzionalita' 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 capacita' di fornire il proprio consenso informato per la partecipazione a questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    diagnostic sensibility in terms of true and false positive and false negative
    sensibilita' diagnostica in termini di veri positivi, falsi positivi e falsi negativi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the time of the histopathological evaluation of the lymphonodes obtained during surgery.
    Al momento della valutazione istopatologica dei linfonodi asportati durante l'intervento chirurgico.
    E.5.2Secondary end point(s)
    Positive predictive value (PPV)
    Valore Predittivo Positivo (VPP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the study
    alla fine dello studio
    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 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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    ogni paziente e' controllo di se stesso
    patient is considered its own control
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    linfoscintigrafia dinamica
    dynamic lymphoscintigrafy
    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 months24
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 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 state14
    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)
    normal treatment plan
    normale programma di assistenza
    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 Decision2012-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
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