Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-001330-17
    Sponsor's Protocol Code Number:PET-COLINA_2013
    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:2013-05-02
    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 number2013-001330-17
    A.3Full title of the trial
    Comparison between diagnostic accuracy of [11C]-choline PET/CT and conventional imaging in prostate cancer patients
    Confronto tra l’accuratezza diagnostica della [11C]-colina e dell’imaging convenzionale nei pazienti con carcinoma prostatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    [11C]-choline PET/CT imaging in prostate cancer patients
    [11C]-colina imaging PET/CT in pazienti affetti da cancro alla prostata
    A.3.2Name or abbreviated title of the trial where available
    PET-CHOLINE_2013
    PET-COLINA_2013
    A.4.1Sponsor's protocol code numberPET-COLINA_2013
    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 SponsorIRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro
    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 supportIRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro
    B.5.2Functional name of contact pointSEGRETERIA DEL COMITATO ETICO
    B.5.3 Address:
    B.5.3.1Street AddressLARGO ROSANNA BENZI 10
    B.5.3.2Town/ cityGENOVA
    B.5.3.3Post code16132
    B.5.3.4CountryItaly
    B.5.4Telephone number+390105552283
    B.5.5Fax number+390105556713
    B.5.6E-mailcomitato.etico@hsanmartino.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 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 name11C-CHOLINE
    D.3.2Product code 11C-CHOL
    D.3.4Pharmaceutical form 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 INN[11C]choline
    D.3.9.3Other descriptive namecholine C-11 injection
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 OSTEOCIS
    D.2.1.1.2Name of the Marketing Authorisation holderCis Bio S.p.A.
    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 nameOSTEOCIS KIT FOR THE PREPARATION OF 99mTc-OXIDRONATE INJECTION
    D.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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
    Prostate adenocarcinoma accounts for 11% of all malignancies, with a total 2.6 million new cases / year estimated in Europe. Mortality rate is 30.6 / 100,000 persons/year. Prostate cancer generally evolves relatively slow and as a result of local growth, the tumor may infiltrate the closest pelvic structures ; besides the frequent metastatic involvement of pelvic lymph nodes, this cancer can metastasize through the bloodstream, with a marked preference for the skeleton.
    L’adenocarcinoma prostatico rappresenta l’11% di tutte le neoplasie maligne, con un’incidenza assoluta che in Europa viene stimata in 2,6 milioni di nuovi casi/anno e con una mortalità pari a 30,6/100 000 soggetti/anno. Il tumore della prostata ha in genere un’evoluzione relativamente lenta e può infiltrare le strutture pelviche adiacenti, oltre al frequente interessamento metastatico dei linfonodi pelvici, la metastatizzazione avviene per via ematogena con spiccata preferenza per lo scheletro.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer accounts for 11% of all malignancies, with 2.6 million new cases/year estimated in Europe. It evolves relatively slow and can metastasize with a marked preference for the skeleton.
    Il cancro alla prostata rappresenta circa l'11% delle tumori ha un'incidenza di 2.6 milioni/anno in Europa. Ha un'evoluzione lenta e può metastatizzare con una spiccata preferenza per le ossa.
    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 LLT
    E.1.2Classification code 10066489
    E.1.2Term Progression of prostate 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
    In this study we aim to evaluate sensitivity and specificity of [11C]-choline PET / CT in identifying the bone involvement in prostate cancer patients and to compare it with that of conventional imaging most largely used for this purpose (bone scan with technetium-99m oxidronate and/or CT scan).
    In pazienti con diagnosi di carcinoma prostatico, sia in fase di stadiazione che di sospetta ripresa di malattia, lo studio si propone di valutare sensibilità e specificità della [11C]-colina PET/TC nell’identificare il possibile coinvolgimento osseo e confrontarle con quello dell’imaging convenzionale routinariamente impiegato a questo scopo (scintigrafia ossea con tecnezio-99m ossidronato e/o TC).
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients included must meet the inclusion criteria as follow:
    we will enroll adult patients (aged>18years) with prostate cancer and suspected skeletal metastasis referring us at the “Nuclear Medicine Unit, IRCCS AOU San Martino - IST for specialist evaluation and that have signed the informed consent for study participation.
    I pazienti inseriti dovranno soddisfare i criteri di inclusione come segue:
    verranno inclusi nello studio soggetti adulti (età>18anni) affetti da carcinoma prostatico con sospette secondarietà scheletriche giunti per consulto specialistico presso l’ Unità Operativa di Medicina Nucleare dell’IRCCS AOU San Martino – IST e che avranno firmato il consenso informato per la partecipazione allo studio.
    E.4Principal exclusion criteria
    The present study will not include healthy volunteers. Likewise, patients affected by conditions requiring emergency treatment, underage, mentally incapable or those who refuse to sign the informed consent will be excluded from the study.
    Saranno esclusi dallo studio volontari sani, minori, soggetti in situazioni di emergenza o non in grado di intendere e di volere, pazienti che si rifiutano di firmare il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    For each patient, the study provides three distinct moments (hereinafter time 1, time 2, time 3).
    At Time 1 patients matching inclusion criteria are enrolled, sign informed consent, and consequently undergo PET / CT with [11C]-choline and convention imaging procedure (the time elapsed between the two examinations must not be greater than 30 days).
    At time 2 results of PET / CT with [11C]-choline and conventional imaging are evaluated.
    The time 3 provides, for each patient, the comparison of the results obtained by the two methods performed. In this study, each patient is the control of himself.
    Per ciascun paziente, lo studio prevede tre distinti momenti (di seguito denominati tempo 1, tempo 2, tempo 3).
    Tempo 1: viene arruolato il paziente che soddisfa i criteri di inclusione, viene richiesta la firma del consenso informato e conseguentemente vengono eseguiti gli esami PET/TC con [11C]-colina e gli esami di imaging convenzionalmente eseguiti a questo scopo (il tempo intercorso tra i due esami non deve essere superiore a 30 giorni).
    Tempo 2: avviene la valutazione dell’ esame PET/CT con [11C]-colina e quello dell’imaging convenzionale.
    Tempo 3: confronto dei risultati ottenuti dalle due metodiche eseguite. In questo studio ogni paziente è controllo di se stesso.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time elapsed between the two examinations must not be greater than 30 days. The comparison between the methods will be after the second examination. Duration of the study 2 years.
    Il tempo intercorso tra i due esami non deve essere superiore a 30 giorni. Il confronto tra le due metodiche applicate seguirà il secondo esame. Lo studio verrà valutato per 2 anni.
    E.5.2Secondary end point(s)
    Not applicable
    Non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Non applicabile
    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 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 Yes
    E.8.2.3.1Comparator description
    tecnezio-99m ossidronate (per l'imaging SPECT) e/o la Tomografia Computerizzata (TC)
    technetium-99m oxidronate (for SPECT imaging) and/or Computed Tomography (CT)
    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.8.5The 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
    The trial will finish when [11C]choline imaging techniques superiority compared with conventional imaging will be demostrated.
    La sperimentazione finirà quando la superiorità della tecnica di imaging con [11C]colina nei confronti delle tecniche considerate gold standard sarà dimostrata.
    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
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 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)
    None
    Nessuno
    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 Decision2013-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 20:37:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA