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    Summary
    EudraCT Number:2017-004881-85
    Sponsor's Protocol Code Number:PSMA-POLM
    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:2021-05-24
    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 number2017-004881-85
    A.3Full title of the trial
    PET-CT with 68Ga-PSMA as a marker of neoangiogenesis in lung adenocarcinoma
    La PET-TC con 68Ga-PSMA come marker di neoangiogenesi nell’adenocarcinoma del polmone
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Positron emission tomography with Gallium-68 labeled with prostate-specific membrane antigen as a marker of tumor neoangiogenesis in lung adenocarcinoma
    La tomografia ad emissione di positroni con Gallio-68 marcato con antigene di membrana prostata-specifico come marcatore di neoangiogenesi tumorale nell’adenocarcinoma del polmone
    A.3.2Name or abbreviated title of the trial where available
    PSMA-POLM
    PSMA-POLM
    A.4.1Sponsor's protocol code numberPSMA-POLM
    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 SponsorAZIENDA OSPEDALIERA SANT'ANDREA
    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 supportAzienda O.U Sant'Andrea
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Sant'Andrea
    B.5.2Functional name of contact pointUOC Medicina Nucleare
    B.5.3 Address:
    B.5.3.1Street Addressvia di Grottarossa 1035/1039
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number0633775538
    B.5.6E-mailalberto.signore@uniroma1.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 name68Ga-PSMA-11
    D.3.2Product code [68Ga-PSMA-11]
    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 codeN.A
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Lung adenocarcinoma
    adenocarcinoma polmonare
    E.1.1.1Medical condition in easily understood language
    Lung neoplasm
    Neoplasia del polmone
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the ability of PET/CT with 68Ga-PSMA-11 to highlight PSMA expression in pulmonary lesions of lung adenocarcinoma patients in vivo
    Valutazione della capacità della PET/TC con 68Ga-PSMA-11 di evidenziare in vivo l’espressione di PSMA nelle lesioni polmonari dei pazienti affetti da adenocarcinoma polmonare
    E.2.2Secondary objectives of the trial
    Correlation between radiopharmaceutical uptake gradient in lung lesions with PET/CT imaging with 68Ga-PSMA-11 and results of immunohistochemical analysis performed on the operating piece

    Correlation between radiopharmaceutical uptake gradient in lung lesions with PET/CT imaging with 68Ga-PSMA-11 and degree of neoplasm differentiation

    Correlation between radiopharmaceutical uptake gradients in lung lesions respectively on PET/CT imaging with 68Ga-PSMA-11 and 18F-DFG
    Correlazione tra gradiente di captazione del radiofarmaco nelle lesioni polmonari all’imaging PET/TC con 68Ga-PSMA-11 e risultati dell’analisi immunoistochimica effettuata su pezzo operatorio

    Correlazione tra gradiente di captazione del radiofarmaco nelle lesioni polmonari all’imaging PET/TC con 68Ga-PSMA-11 e grado di differenziazione della neoplasia;

    Correlazione tra gradienti di captazione del radiofarmaco nelle lesioni polmonari all’imaging PET/TC con 68Ga-PSMA-11 e con 18F-FDG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - men or women aged 18 or older;
    - histologically proven lung adenocarcinoma;
    - disease staging by PET/CT with 18F-FDG;
    - patients candidates for surgical removal of the neoplasm;
    - signature of informed consent; patients must sign an informed consent stating that they understand the experimental nature of the study
    - uomo o donna di età maggiore di 18 anni;
    - diagnosi di adenocarcinoma polmonare istologicamente accertato;
    - stadiazione di malattia mediante PET/TC con 18F-FDG;
    - pazienti candidati all’asportazione chirurgica della neoplasia;
    - firma del consenso informato; i pazienti devono firmare un consenso informato in cui dichiarano di comprendere la natura sperimentale dello studio.
    E.4Principal exclusion criteria
    - pregnancy or breastfeeding;
    - positive pregnancy test for women of childbearing potential
    - history of allergic reaction to the active substance or to any of the components of the radiopharmaceutical
    - presence of heart or respiratory diseases that represent a contra-indication to the surgical intervention;
    - inoperable patients for allergies or hypersensitivity to anesthetics;
    - participation in a clinical trial in which an investigational drug was administered within 30 days of 5 half-lives prior to the study drug
    - inability to maintain a supine position for the entire duration of the study (for example due to cough, severe arthritis, etc.) or to complete the study for other reasons (for example due to claustrophobia not responsive to oral anxiolytics, radio- phobia etc.).
    - patients with grade 3 renal of hepatic impairment according to US National Cancer Institute's "Common
    Terminology Criteria for Adverse Events V5” (CTCAE).
    - stato di gravidanza o allattamento;
    - test di gravidanza positivo per le donne potenzialmente fertili;
    - anamnesi di reazioni allergiche o ipersensibilità al principio attivo
    o ad uno qualsiasi dei componenti del radiofarmaco;
    - stadi di malattia che necessitano di terapie sistemiche;
    - presenza di malattie cardiache o respiratorie che rappresentino
    una contro-indicazione all'intervento chirurgico;
    - pazienti inoperabili per allergie o ipersensibilità agli anestetici;
    - partecipazione ad uno studio clinico in cui è stato somministrato un farmaco sperimentale entro 30 giorni o 5 emivite prima del farmaco in studio;
    - incapacità di mantenere una posizione supina per l¿intera durata dello studio (ad esempio a causa di tosse, artrosi severa ecc…) o di completare lo studio per altre ragioni (ad esempio a causa di
    claustrofobia non responsiva agli ansiolitici orali, radio-fobia
    ecc..);
    - pazienti con alterazione della funzione renale o epatica di grado 3 o superiore secondo gli US National Cancer Institute's "Common Terminology Criteria for Adverse Events V5” (CTCAE).
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of the "detection rate" (ratio between the number of patients with PET imaging positive lesions and the total number of patients) of 68Ga-PSMA-11 in lung lesions of patients with lung adenocarcinoma
    Calcolo del “detection rate” (rapporto tra numero di pazienti con lesioni positive all’imaging PET e numero totale dei pz) del 68Ga-PSMA-11 nelle lesioni polmonari dei pazienti affetti da adenocarcinoma polmonare
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 1-7
    Giorni 1-7
    E.5.2Secondary end point(s)
    Correlation between mean and maximal standardized uptake values (SUVmean, SUVmax) measured on lung lesions on PET-CT imaging with 68Ga-PSMA-11 and percentage of positivity for anti-PSMA antibodies detected at the immunohistochemical analysis performed on the operating piece; Correlation between mean and maximal standardized uptake values (SUVmean, SUVmax) measured on lung lesions on PET-CT imaging with 68Ga-PSMA-11 and degree of neoplasm differentiation; Correlation between radiopharmaceutical uptake gradients in lung lesions respectively on PET/CT imaging with 68Ga-PSMA-11 and 18F-DFG
    Correlazione tra mean e maximal standardized uptake values (SUVmean, SUVmax) misurati sulle lesioni polmonari all’imaging PET-TC con 68Ga-PSMA-11 e percentuale di positività per anticorpi anti-PSMA rilevata all’analisi immunoistochimica effettuata su pezzo operatorio; Correlazione tra mean e maximal standardized uptake values (SUVmean, SUVmax) misurati sulle lesioni all’imaging PET con 68Ga-PSMA-11 e grado di differenziazione della neoplasia; Correlazione tra mean e maximal standardized uptake values (SUVmean, SUVmax) misurati sulle lesioni rispettivamente all’imaging PET con 68Ga-PSMA-11 e con 18F-FDG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 18-27; Days 18-27; Days 1-7
    Giorni 18-27; Giorni 18-27; Giorni 1-7
    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 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.8.6 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 years1
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days36
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days36
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    assistance for patients at the end of their participation in the study will be guaranteed by the NHS.
    L’assistenza dei soggetti al termine della loro partecipazione allo studio sarà garantita dal SSN.
    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 Decision2020-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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