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    Summary
    EudraCT Number:2014-005140-18
    Sponsor's Protocol Code Number:RAME-01
    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:2018-01-08
    Trial results View 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 number2014-005140-18
    A.3Full title of the trial
    Diagnostic and clinical value of fused 64CuCl2-PET/MRI in prostate cancer relapse. Comparison with multiparametric MRI (mMRI) and 18F-Choline-PET/MRI
    Efficacia diagnostica e impatto clinico della metodica 64CuCl2-PET/RM nello studio delle recidive da adenocarcinoma prostatico. Comparazione con Risonanza Magnetica Multiparametrica (RMM) e 18F-Colina-PET/RM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic value of 64CuCl2-PET/MRI in prostate cancer relapse.
    Valore diagnostico di 64CuCl2-PET/MRI nel carcinoma prostatico
    A.3.2Name or abbreviated title of the trial where available
    Diagnostic and clinical value of 64CuCl2-PET/MRI in prostate cancer relapse.
    Ruolo diagnostico clinico di 64CuCl2-PET/MRI nello studio delle recidive da carcinoma prostatico
    A.4.1Sponsor's protocol code numberRAME-01
    A.5.4Other Identifiers
    Name:Rame01Number:30UCS2014
    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 SponsorENTE OSPEDALIERO OSPEDALI GALLIERA
    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 supportACOM Advanced Center Oncology Macerata
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationE.O.Ospedali Galliera - Genova
    B.5.2Functional name of contact pointUfficio del Coordinatore Scientific
    B.5.3 Address:
    B.5.3.1Street AddressMura delle Cappuccine,14
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16128
    B.5.3.4CountryItaly
    B.5.4Telephone number0105634228
    B.5.5Fax number0105634201
    B.5.6E-mailucs@galliera.it
    D. IMP Identification
    D.IMP: 1
    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 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.3.2Product code 64CuCl2
    D.3.4Pharmaceutical form Solution for infusion
    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.3.9.1CAS number 7447-39-4
    D.3.9.2Current sponsor codeRAME 01
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/µl megabecquerel(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy
    Pazienti affetti da carcinoma prostatico che evidenzino progressione biochimica dopo trattamento chirurgico o radioterapico
    E.1.1.1Medical condition in easily understood language
    Patients affected by prostate cancer previously treated with surgery or radiotherapy with suspected disease recurrence
    Ripresa di malattia nel carcinoma prostatico
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038604
    E.1.2Term Reproductive system and breast disorders
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study was firstly to assess the diagnostic performance of fused 64CuCl2-PET/MRI in patients with suspected relapse of prostate cancer after surgery or EBRT. In addition we want to compare the accuracy of fused 64CuCl2-PET/MRI with that of mMRI,18F-Choline-PET/MRI, 18F-Choline-PET/CT, and contrast enhanced CT in detecting local recurrence, lymph node, and bone metastases
    L’obiettivo primario dello studio è verificare l’efficacia della 64CuCl2 PET/RM (test sperimentale) rispetto alla 18F-Colina PET/TC, alla 18F-Colina PET/RM e alle metodiche di imaging radiologico quali TC con mdc e RM (test standard) nell’individuazione precoce di ripresa di malattia. Verrà calcolata la sensibilità, la specificità, il valore predittivo negativo, il valore predittivo positivo e l'accuratezza diagnostica della metodica 64CUCl2 PET/RM e confrontata con quella relativa alle altre metodiche diagnostiche tradizionali nello stesso gruppo di pazienti. In particolare verranno confrontati i risultati della 64CuCl2 PET/RM con quelli della 18F-Colina PET/TC e della 18F-Colina PET/RM.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    -to assess whether 64CuCl2-PET/MRI could eventually influence patient management, treatment decisions and outcome in comparison with all available data. Of course all patients will be followed up and treated independently by 64CuCl2-PET/MRI results;
    -to test the association between 64CuCl2-PET/MRI detection rate, PSA level and Gleason score;
    -to assess the association between the standard uptake value (SUV-max) of 64CuCl2-PET and apparent diffusion coefficient (ADC) value of local recurrence and lymph node metastases;
    -To assess and compare the diagnostic performance of 3 further acquisitions of 64CuCl2 PET/CT;
    -To acquire new information and refine the safety profile of 64CuCl2 for the execution of PET/CT diagnostics;
    -To study the kinetic profile of 64CuCl2.
    -Valutare in quanti pazienti sarebbe stato cambiato il management clinico-terapeutico in base alla metodica diagnostica;
    -Verificare la correlazione dei risultati della PET/RM con i livelli di PSA e il Gleason score;
    -Verificare la correlazioni tra le SUV-max dei traccianti e il valore di ADC (Coeff. di Diffusione
    Apparente) della RMM;
    -Confrontare risultati in termini di sensibilità, la specificità, il valore predittivo negativo, il valore
    predittivo positivo e l'accuratezza di ulteriori 3 acquisizioni 64CuCl2 PET/CT;
    -Approfondire il profilo di sicurezza della somministrazione di 64CuCl2 per l’esecuzione di esame PET/CT diagnostico;
    -Valutare la cinetica del 64CuCl2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -years > 18 (no upper age limit)
    -all histologically proven prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy
    -Gleason score ≥6,
    -increasing levels of PSA and PSA doubling time (DT) ≤6 months.
    -Informed consent available
    -età superiore a 18 anni (nessun limite superiore di età)
    -pazienti operati o già trattati con brachi/radioterapia per carcinoma prostatico.
    -diagnosi istologica di carcinoma prostatico
    -Gleason score > 6
    - livelli di PSA in aumento (tempo di raddoppiamento inferiore ai 6 mesi)
    - rilascio del consenso informato scritto
    E.4Principal exclusion criteria
    -comorbidity for other neoplasms
    -inability to perform MRI
    -known hypersensitivity to the substances or excipients contained in the tracers and contrast agent
    -comorbilità per altre neoplasie
    - nota impossibilità ad eseguire esame dì Risonanza Magnetica
    - nota ipersensibilità a principio attivo o eccipienti contenuti nei traccianti e nel mdc
    - ogni altra condizione medica che controindichi lo studio a giudizio dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is to evaluate the accuracy defined as: (True Negative + True Positive)/(True Negative + True Positive + False Negative + False Positive) = (Number of correct assessments)/Number of all assessments).
    L'end point primario dello studio è quello di valutare l'accuratezza definita come il rapporto fra la somma dei veri negativi e dei veri positivi sul totale dei pazienti.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    1. The secondary end point is to evaluate the specificity defined as: True Negative/(True Negative + False Positive) = (Number of true negative assessment)/(Number of all negative assessment)
    2. The secondary end point is to evaluate the positive predictive value (PPV) defined as: True positive/(True positive+ False positive).
    3. The secondary end point is to evaluate the negative predictive value (NPV) defined as: True negative/(True negative+ False negative).
    4. The secondary end point is to evaluate the sensitivity defined as: True Positive/(True Positive + False Negative) = (Number of true positive assessment)/(Number of all positive assessment)
    5. Assess and compare the sensitivity, specificity, PPV, NPV and accuracy as defined above, considering further PET / CT exams performed after 4 and 24 hours from baseline
    6. Safety endpoints will be: blood pressure, heart and respiratory rate, signs and symptoms, blood tests (blood count, C-reactive protein, transaminases and gamma GT, ALP, creatinine and nitrogen) and glucose by glucometer.
    7. kinetics endpoints will be:
    - The absorbed dose by determining the volume of interest (VOI) of the relevant internal body areas using co-registered PET / CT images at 90 minutes and at 4 and 24 hours from injection.
    - The masses and the cumulative activity for the internal body areas involved.
    1. Specificità inteso comera pporto fra soggetti negativi al test sperimentale (Ts-) e i veri negativi (VN)
    2. Valore predittivo positivo (VPP): rapporto fra VP e la totalità dei soggetti positivi al test sperimentale (T+)
    3. Valore predittivo negativo (VPN): rapporto fra VN e la totalità dei soggetti negativi al test sperimentale (T-)
    4. Sensibilità intesa come il rapporto fra soggetti positivi al test sperimentale (Ts+) e i veri positivi (VP)
    5. Valutare e confrontare sensibilità, specificità, VPP, VPN e accuratezza come definiti sopra, considerando le ulteriori esami PET/CT dopo 4 ore e a 24 ore dal tempo zero
    6. endpoints di sicurezza saranno: pressione arteriosa, frequenza respiratoria e cardiaca, segni e sintomi, esami ematici (emocromo, proteina C reattiva, transaminasi e gamma GT, ALP, creatinina, azoto) e glicemia mediante glucometro.
    7. Endpoints di cinetica di assorbimento saranno:
    - la dose assorbita mediante determinazione dei volumi di interesse (VOI) degli organi interessati utilizzando immagini co-registrate PET/CT sia a 90' che a 4 e 24 ore dall'iniezione.
    - le masse e l’attività cumulata per gli organi interessati.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 12 months
    2. 12 months
    3. 12 months
    4. 12 months
    5. 12 months
    6. baseline, 7 and 24 hours after the first IMP administration
    7. 90 minutes, 4 and 24 hours from injection.
    1. 12 mesi
    2. 12 mesi
    3. 12 mesi
    4. 12 mesi
    5. 12 mesi
    6. alla visita basale e dopo 7 e 24 ore dalla prima somministrazione
    7. 90 minuti, 4 e 24 ore dopo l'iniezione
    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 Yes
    E.6.13.1Other scope of the trial description
    to assess whether 64CuCl2-PET/MRI could eventually influence patient management
    Impatto clinico eventuale
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio pilota di confronto tra metodiche diagnostiche nello stesso gruppo di pazienti.
    pilot study comparing different diagnostic methods in the same group of patients.
    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.8.3 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 years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    Our diagnostic trial does not affect in any way the therapeutic treatment or patient assistance.
    la sperimentazione diagnostica non influenza in alcun modo il trattamento terapeutico o l'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 Decision2015-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
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