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    Summary
    EudraCT Number:2016-001774-15
    Sponsor's Protocol Code Number:GR-2013-02357486
    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:2021-06-08
    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 number2016-001774-15
    A.3Full title of the trial
    THE ROLE OF 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
    IL RUOLO DELLA TECNICA DI IMAGING TC/PET CON 18F-FAZA NELLA IDENTIFICAZIONE DELLE METASTASI LINFONODALI IN PAZIENTI AFFETTI DA CARCINOMA A CELLULE RENALI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    THE ROLE OF 18F-FAZA PET IN DETECTING LYMPH NODE METASTASES IN PATIENTS WITH KIDNEY TUMOR
    IL RUOLO DELLA TECNICA PET CON RADIOFARMACO DENOMINATO FAZA PER IDENTIFICARE PAZIENTI CON TUMORE DEL RENE E METASTASI NEI LINFONODI
    A.3.2Name or abbreviated title of the trial where available
    FAZA RCC LNI
    FAZA RCC LNI
    A.4.1Sponsor's protocol code numberGR-2013-02357486
    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 SAN RAFFAELE
    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 supportBANDO PROGETTI DI RICERCA GIOVANI RICERCATORI 2013
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele - Milano
    B.5.2Functional name of contact pointurologia
    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 number02.2643.7286
    B.5.5Fax number02.2643.7298
    B.5.6E-mailumbertocapitanio@gmail.com
    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 No
    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 name1-(5-Deoxy-5-fluoro-a-D-arabinofuranosil)-2-nitroimidazolo
    D.3.2Product code [18F]FAZA
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeFAZA
    D.3.9.3Other descriptive nameFAZA
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number160 to 400
    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 Yes
    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
    kidney cancer
    tumore del rene
    E.1.1.1Medical condition in easily understood language
    kidney cancer
    tumore del rene
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10023400
    E.1.2Term Kidney cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the accuracy of FAZA TC-PET in identifying lymph node metastases in patients with kidney cancer
    Testare l¿abilit¿ della tecnica TC-PET FAZA nell¿identificazione delle metastasi linfonodali in pazienti affetti da RCC
    E.2.2Secondary objectives of the trial
    To evaluate and to quantify tracer uptake in primary kdney tumor and in lymph node and distant metastases, as well
    Valutare e quantificare l¿uptake di tracciante a livello del tumore renale primario e di eventuali altre sedi di metastasi a distanza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -adults (age>18yrs) affected by renal cell carcinoma (any subtype) with or without sarcomatous features
    -candidates for nephrectomy and lymph node dissection
    -cT4 mass or tumor diameter >10 cm or lymphadenopathies (cN1)
    -negative pregnancy test in case of woman in pregnancy age
    -to be able to understand the informed consent
    -the informed consent must be accepted and signed
    - pazienti adulti (eta’ >18 anni) affetti da renal cell carcinoma (RCC) di qualsiasi sottotipo istologico, indipendentemente dalla variante sarcomatoide
    - pazienti candidati a intervento chirurgico di nefrectomia radicale e linfoadenectomia estesa
    - tumori in stadio clinico cT4 (qualsiasi cN) o tumori di diametro superiore a 10 cm (qualsiasi cTcN) o presenza di linfoadenopatie all’imaging preoperatorio (cN1)
    - capacità di intendere e comprendere il consenso informato
    - in caso di donne in eta’ fertile, un test di gravidanza deve essere somministrato per escludere una gravidanza in corso
    - accettazione e firma del consenso informato
    E.4Principal exclusion criteria
    -neoadjuvant therapy with TKI or MTOR-i
    -pregnancy and breast feeding
    -females in pregancy age and no contraceptive use
    -ECOG>1
    -eGFR<30 or Child-Pugh B or C or NYHA III-IV
    - Assunzione di farmaci sistemici (TKI o MTOR-i) per terapia neo-adiuvante del tumore del rene
    - Gravidanza e allattamento
    - Donne in età fertile che non accettano di fare uso di contraccettivi per evitare una gravidanza
    - Performance status ECOG >1
    - Grave insufficienza renale (eGFR<30) o epatica (Child-Pugh B o C) o scompenso cardiaco grave (NYHA Class III-IV)
    E.5 End points
    E.5.1Primary end point(s)
    Specificita’, sensibilita’ e accuratezza della tecnica TC/PET FAZA nell’identificare metastasi linfonodali
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 anni
    E.5.2Secondary end point(s)
    Specificita¿, sensibilita¿ e accuratezza della tecnica TC/PET FAZA nell¿identificare metastasi a distanza; Specificita¿, sensibilita¿ e accuratezza della tecnica TC/PET FAZA nell¿identificare il primitivo renale
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 anni; 3 anni
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.5.1Number of sites anticipated in the EEA1
    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 years3
    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 years3
    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: 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 state0
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    Standard surgical panning (nephrectomy+lymph node dissection)
    I pazienti saranno sottoposti all¿iter terapeutico standard previsto per la loro patologia (intervento chirurgico di nefrectomia e linfoadenectomia.
    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 Decision2017-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
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