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    Summary
    EudraCT Number:2012-003164-50
    Sponsor's Protocol Code Number:CEUSUM
    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:2012-08-02
    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 number2012-003164-50
    A.3Full title of the trial
    CONTRAST ENHANCED ULTRASOUND (CEUS) IN UVEAL MELANOMA: QUANTITATIVE ASSESSMENT OF TUMOR RESPONSE TO GAMMA KNIFE RADIOSURGERY (GKR)
    ECOGRAFIA CON MEZZO DI CONTRASTO (CEUS) NEL MELANOMA UVEALE: VALUTAZIONE QUANTITATIVA DELLA RISPOSTA TUMORALE ALLA GAMMA KNIFE (GKR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ULTRASOUND (CEUS) IN UVEAL MELANOMA: EVALUATION OF RESPONSE TO GAMMA KNIFE RADIOSURGERY
    ecografia nel melanoma uveale: valutazione della risposta alla gamma knife
    A.4.1Sponsor's protocol code numberCEUSUM
    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 S. RAFFAELE DI MILANO
    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 supportBRACCO IMAGING
    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 pointRadiologia Diagnostica
    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 number0226432388
    B.5.5Fax number0226432165
    B.5.6E-mailventurini.massimo@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 Yes
    D.2.1.1.1Trade name SONOVUE*1FL 8MCG+1SIR 5ML+ADAT
    D.2.1.1.2Name of the Marketing Authorisation holderBRACCO SpA DIV.FARMACEUTICA
    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 and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNesafluoruro di zolfo
    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 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 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 affected by uveal melanoma
    Pazienti adulti affetti da melanoma uveale primitivo
    E.1.1.1Medical condition in easily understood language
    ocular cancer
    tumore oculare
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061252
    E.1.2Term Intraocular melanoma
    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
    to determine if high-frequency CEUS using Sonovue, Bracco can be performed in the eye to visualize and quantify contrast enhancement in uveal melanoma before and after GKR.
    determinare se CEUS ad alta frequenza usando Sonovue, Bracco, può essere effettuato nell’occhio per visualizzare e quantificare il contrast enhancement a livello del melanoma uveale prima e dopo GKR.
    E.2.2Secondary objectives of the trial
    -Identification of a correlation between response at A- and B- ultrasonography and at CEUS of the irradiated tumour.
    Evaluation of the possibility to assess CEUS quantitative parameters in future studies as predictors of tumour response to treatments.
    possibilità di valutare i parametri quantitativi di CEUS in studi futuri, come predittori di risposta del tumore alle terapie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Adult subjects of >18 years of age;
    •Diagnosis of previously untreated Uveal Melanoma;
    •Tumour thickness >3 mm;
    •Eligibility for Gamma Knife Radiosurgery;
    •Adequate organ function (normal kidney and liver biochemical parameters, normal heart and bone marrow function);
    •Fertile females practicing adequate contraception;
    •ECOG score 0-1;
    •Life expectancy of at least 6 months;
    •Signed informed consent;
    -soggetti adulti di&gt; 18 anni di età;
    -diagnosi di melanoma uveale precedentemente non trattato;
    -spessore del tumore &gt; 3 mm;
    -idoneità alla radiochirurgia Gamma Knife;
    -adeguata funzionalita' d'organo (normali parametri biochimici di rene e fegato, cuore e midollo osseo);
    -pazienti di sesso femminile che pratichino adeguata contraccezione ;
    -punteggio ECOG 0-1;
    -aspettativa di vita di almeno 6 mesi;
    -capacita' di comprendere e firmare il modulo di consenso informato;
    E.4Principal exclusion criteria
    -Previous local treatment of Uveal Melanoma;
    -Tumour thickness < 3 mm;
    -Patients non eligible to brain-MRI pre-gamma knife due to anatomical or functional impairment;
    -Presence of distant metastasis;
    -Significant cardiovascular diseases requiring medical intervention or prior myocardial infarction within the last 2 years;
    -Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrollment into the present study;
    -Any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance.
    -precedenti trattamenti locali del melanoma uveale;
    -spessore del tumore &lt; 3 mm;
    -pazienti non sottoponibili a MRI cerebrale pre gammaknife causa problematiche anatomiche o funzionali;
    -presenza di metastasi lontane dalla sede del tumore;
    -patologia cardiovascolari significative che richiedano intervento medico o infarti del miocardio occorsi negli ultimi 2 anni;
    -partecipazione parallela ad altri studi clinici o partecipazione ad altri studi clinici nei 3 mesi precedenti la'rruolamento a questo studio;
    -qualsiasi altro impedimento che possa far presupporre al clinico una scarsa compliance da parte del paziente.
    E.5 End points
    E.5.1Primary end point(s)
    Quantitative assessment of tumour vascularization in a specific R.O.I. (Region of Interest) pre and after tumour treatment with GKR by using different quantitative parameters: the main that will be investigated are TTP, RT, and PE (see the study procedures section for details).
    Valutazione quantitativa della vascolarizzazione tumorale in una regione specifica d'interesse pre e post trattamento del tumore con GKR utilizzando diversi parametri quantitativi. I principali parametri che saranno oggetto di indagine sono i seguenti:TTP, RT, e PE (si veda la sezione di studio le procedure per i dettagli).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    -Correlation between variation of tumour size at A- and B- scan ultrasonography and of the quantitative parameters (TTP, RT, PE, AUC, WiPI, WiR, MTT ).
    -Correlation between quantitative parameters’ variation and local and/or systemic disease recurrence.
    -Monitoring of adverse events at the injection site, systemic allergic reactions, and other adverse events occurring within 30 minutes following Sonovue administration (Common Toxicity Criteria 4.0).
    -correlazione tra variazione di dimensioni del tumore nelle ecografie A e B-scan ed i parametri quantitativi (TTP, RT, PE, AUC, WIPI, WIR, MTT).
    -correlazione tra la variazione dei parametri quantitativi e locali e / o reiterazione della malattia sistemica
    -Monitoraggio degli eventi avversi al sito di iniezione, delle reazioni allergiche sistemiche e di altri eventi avversi che si verifichino entro 30 minuti dopo la somministrazione Sonovue (Common Toxicity Criteria (4.0).)
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    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 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) 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 years0
    E.8.9.1In the Member State concerned months30
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state20
    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)
    patients will continue the usual diagnostic monitoring plan for their pathology
    i pazienti continueranno i normali controlli diagnostici per il monitoraggio della 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 Decision2012-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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