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    Summary
    EudraCT Number:2019-002534-37
    Sponsor's Protocol Code Number:RAME-04
    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:2021-04-16
    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 number2019-002534-37
    A.3Full title of the trial
    Diagnostic and predictive role of 64CuCl2 PET / CT in bladder cancer patients eligible for chemotherapy
    Ruolo diagnostico e predittivo della 64CuCl2 PET/CT nei pazienti affetti da tumore della vescica candidati a chemioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic-predictive value of copper-64 dichloride in bladder cancer patients eligible for chemotherapy
    Valore diagnostico-predittivo del dicloruro di rame-64 nei pazienti con tumore vescicale candidati a chemioterapia
    A.3.2Name or abbreviated title of the trial where available
    Diagnostic-predictive role of 64CuCl2 in urothelial tumors
    Ruolo diagnostico-predittivo del 64CuCl2 nei tumori uroteliali
    A.4.1Sponsor's protocol code numberRAME-04
    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 supportA.C.O.M.- Advanced Center Oncology Macerata - SRL
    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
    B.5.2Functional name of contact pointS.C. Medicina Nucleare
    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 number0105634541
    B.5.6E-mailarnoldo.piccardo@galliera.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 name64 Rame Cloruro
    D.3.2Product code [64Cu (II)Cl2]
    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.3.8INN - Proposed INNrame cloruro ( 64CuCl2)
    D.3.9.2Current sponsor code(64Cu)CuCl2
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number925
    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
    bladder cancer patients eligible for cisplatin chemotherapy
    pazienti affetti da tumore della vescica e candidati a chemioterapia con cisplatino
    E.1.1.1Medical condition in easily understood language
    bladder cancer patients eligible for cisplatin chemotherapy
    pazienti con tumore vescicale candidati a chemioterapia
    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 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    evaluate the diagnostic accuracy of the 64CuCl2-PET / CT examination in urothelial tumors. In particular, the Detection Rate (DR) and sensitivity of this diagnostic technique will be assessed and compared with that relating to the CT examination (reference imaging method).
    valutare l’accuratezza diagnostica dell’esame 64CuCl2-PET/CT nei tumori uroteliali. In particolare saranno valutati il Detection Rate (DR) e la sensibilità di tale tecnica diagnostica e comparato con quello relativo all’esame CT (metodica di imaging di riferimento).
    E.2.2Secondary objectives of the trial
    evaluate the role of the 64CuCl2-PET / CT examination in predicting the response to neo-adjuvant of first-line cisplatin chemotherapy
    valutare il ruolo dell’esame 64CuCl2-PET/CT nel predire la risposta alla chemioterapia neo-adiuvante o alla terapia di prima linea con cisplatino nei pazienti affetti da tumori della vescica muscolo-invasivi o nei pazienti metastatici
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with invasive muscle disease (Documented by the reference of the histopathological report)
    2. Patients with metastatic disease (Documented by clinical report)
    3. Age = 50 years at the time of enrollment (There are no upper age limits that contraindicate the performance of 64CuCl2-PET / CT)
    4. Previous histological, documentable diagnosis of primary adenocarcinoma of the bladder (Documented by the reference of the histopathological report and / or clinical report)
    5. Clinical indication on staging or restaging (Documented by clinical report)
    6. MR Imaging and / or CT and / or bone scan tests no older than 30 days (Documented by clinical report)
    7. Negative clinical history for other past or ongoing neoplastic pathologies, with the exception of non-melanoma skin carcinomas (Anamnestic relief)
    8. Karnofski index = 80% (In the opinion of the Investigator)
    9. Absence of other relevant comorbidities (see: exclusion criteria, medical history)
    10. Full ability to understand the information contained in the illustrative documentation for the Subject (In the opinion of the Investigator)
    11. Full ability to sign informed consent (In the opinion of the Investigator)
    1. Pazienti affetti da malattia muscolo invasiva (Documentata dal riferimento del referto istopatologico)
    2. Pazienti affetti da malattia metastatica (Documentato da relazione clinica)
    3. Età= 50 anni al momento arruolamento (Non esistono limiti superiori di età che controindichino lo svolgimento della 64CuCl2-PET/CT)
    4. Pregressa diagnosi istologica, documentabile, di adenocarcinoma primitivo della vescica (Documentata dal riferimento del referto istopatologico e/o da relazione clinica)
    5. Indicazione clinica sulla stadiazione o alla ristadiazione (Documentato da relazione clinica)
    6. Esami di Imaging MR e/o CT e/o di scintigrafia ossea non più vecchi di 30 giorni (Documentato da relazione clinica)
    7. Storia clinica negativa per altre patologie neoplastiche pregresse od in atto, con l’eccezione di carcinomi cutanei non-melanoma (Rilievo anamnestico)
    8. Indice di Karnofski = 80% (A giudizio dello Sperimentatore)
    9. Assenza di altre comorbilità rilevanti (cfr: criteri di esclusione, Rilievo anamnestico)
    10. Piena capacità di comprendere le informazioni riportate nella documentazione illustrativa per il Soggetto (A giudizio dello Sperimentatore)
    11. Piena capacità di sottoscrivere il consenso informato (A giudizio dello Sperimentatore)
    E.4Principal exclusion criteria
    1. Anemia with Hb <9 gr / dL (Laboratory data)
    2. Presence of symptoms or signs of sepsis and / or evidence of acute infections (In the opinion of the investigator)
    3. AST> 1.5 times the upper limit of the normal range (laboratory data)
    4. ALT> 1.5 times the upper limit of the normal range (Laboratory data)
    5. Total bilirubin> 1.5 times the upper limit of the normal range (laboratory data)
    6. Copper metabolism diseases (Menkes disease, Wilson disease, anamnestic relief)
    7. Any condition, material, logistics, or Subjective, which, even in the opinion of the Principal Investigator, may condition the compliance of the Subject to the execution of the procedures set out in the Protocol (In the opinion of the Investigator)
    8. Inability to understand the content of the information documentation for the Subject (In the opinion of the Investigator)
    1.Anemia con Hb<9 gr/dL (Dati di laboratorio)
    2. Presenza di sintomi o segni di sepsi e/o evidenza di infezioni acute (A giudizio dello sperimentatore)
    3. AST >1.5 volte il limite superiore del range di normalità (Dati di laboratorio)
    4. ALT >1.5 volte il limite superiore del range di normalità (Dati di laboratorio)
    5. Bilirubina totale > 1.5 volte il limite superiore del range di normalità (Dati di laboratorio)
    6. Malattie del metabolismo del rame (malattia di Menkes, malattia di Wilson,Rilievo anamnestico)
    7. Qualsiasi condizione, materiale, logistica, o Soggettiva, che, anche a giudizio dello Sperimentatore Principale, possa condizionare la compliance del Soggetto alla esecuzione delle procedure previste dal Protocollo (A giudizio dello Sperimentatore)
    8. Incapacità a comprendere il contenuto della documentazione informativa per il Soggetto (A giudizio dello Sperimentatore)
    E.5 End points
    E.5.1Primary end point(s)
    evaluate the diagnostic accuracy of the 64CuCl2-PET / CT examination in urothelial tumors. In particular, the Detection Rate (DR) and sensitivity of this diagnostic technique will be assessed and compared with that relating to the CT examination (reference imaging method).
    valutare l’accuratezza diagnostica dell’esame 64CuCl2-PET/CT nei tumori uroteliali. In particolare saranno valutati il Detection Rate (DR) e la sensibilità di tale tecnica diagnostica e comparato con quello relativo all’esame CT (metodica di imaging di riferimento).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    evaluate the predictive ability of the radiotracer to chemotherapy with cisplatin
    valutare la capacità predittiva del radiotracciante alla chemioterapia con cisplatino
    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 Yes
    E.8.1.7.1Other trial design description
    Studio pilota di efficacia diagnostica e predittiva nello stesso gruppo di pazienti
    Pilot study of diagnostic and predictive efficacy 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.8.2.4Number 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 Yes
    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 years2
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days73
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days73
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-04-16. Yes
    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 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)
    patients continue to be followed by the medical staff with whom they are being treated as before participating in the study.
    i pazienti continueranno a essere seguiti dallo staff medico presso cui è in cura come prima della partecipazione allo studio.
    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 Decision2021-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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