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    Summary
    EudraCT Number:2012-000994-22
    Sponsor's Protocol Code Number:GADOTATOC-EUS
    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:2012-03-29
    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 number2012-000994-22
    A.3Full title of the trial
    Accuracy and clinical impact of 68-Ga-labeled octreotide analogues PET in diagnosis and staging of duodeno-pancreatic neuroendocrine tumours; proposal of a multicenter, prospective clinical trial
    Accuratezza ed impatto clinico della PET con analoghi dell'octreotide marcati con 68-Ga nella diagnosi e nello staging dei tumori neuroendocrini duodeno-pancreatici; proposta di uno studio prospettico multicentrico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison among 68-Ga-labeled octreotide analogues PET, TC and endoscopic ultrasonography in the study of duodeno-pancreatic neuroendocrine tumors.
    Confronto tra PET con analoghi dell'octreotide marcati con 68-Ga, TC ed ecoendoscopia nello studio dei tumori neuroendocrini duodeno-pancreatici.
    A.4.1Sponsor's protocol code numberGADOTATOC-EUS
    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 ARCISPEDALE S. MARIA NUOVA
    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 OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
    B.5.2Functional name of contact pointU.O. di Medicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressViale Risorgimento 80
    B.5.3.2Town/ cityREGGIO EMILIA
    B.5.3.3Post code42100
    B.5.3.4CountryItaly
    B.5.4Telephone number0522 296111
    B.5.6E-mailannibale.versari@asmn.re.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-octreotide analog
    D.3.2Product code NA
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code68Ga-octreotide analog
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number185
    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
    Patients suspected to be affected by neuroendocrine duodeno-pancreatic neoplasm.
    Pazienti con sospetta neoplasia neuroendocrina duodeno-pancreatica.
    E.1.1.1Medical condition in easily understood language
    Patients suspected to be affected by neuroendocrine duodeno-pancreatic neoplasm.
    Pazienti con sospetta neoplasia neuroendocrina duodeno-pancreatica.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10014713
    E.1.2Term Endocrine neoplasms malignant and unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to compare accuracy of MDCT and PET in the diagnosis of primary duodeno-pancreatic NET.
    confrontare l'accuratezza della TC mutistrato multidetectore e della PET nella diagnosi dei NET primitivi duodeno-pancreatici
    E.2.2Secondary objectives of the trial
    to compare accuracy of MDCT, EUS and PET in the diagnosis of primary duodeno-pancreatic NET. To evaluate clinical impact of PET. To compare accuracy of MDCT and PET in the staging of duodeno-pancreatic NET.
    Confrontare l'accuratezza di TC,EUS e PET nella diagnosi dei NET primitivi duodeno-pancreatici.Valutare l'impatto clinico della PET.Confrontare l'accuratezza di TC e PET nella stadiazione dei NET duodeno-pancreatici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients affected by proved MEN-I, in whom a neoplasm in the duodenopancreatic area is suspected. 2. Patients with clinical diagnosis of carcinoid syndrome or Zollinger-Ellison syndrome. 3. Patients with insulinoma, as proved by fasting test. 4. Patient with clinical pictures and laboratory findings suggesting other infrequent islet cell tumours. 5. Patients with subtle clinical abnormalities, or laboratory findings (for instance elevated serum chromogranine A levels) suggesting a NET. 6. Patients who had previously undergone surgery intended as curative for a histologically confirmed NET. 7. Patients undergoing diagnostic work-up for a periduodenal or pancreatic lesion incidentally found during abdominal ultrasound (not performed for suspicion of a NET) and with ultrasonographic characteristics (rounded, hypoechoic or egg-eye, well demarcated) suspicious for NET. 8. Patients who were diagnosed with NET metastasis with unknown primary location of the disease.
    1,. Pazienyi affetti da NEN-I, nei quai si sospetti una neoplasia nell'area duodeno-pancreatica. 2 pazienti con diagnosi clinica di sindrome da carcinoide o di sindrome di Zollinger Ellison. 3 Pazienti con insulinoma dimostrato da test del digiuno, 4 pazieni con quadri clinici o rilievi di laboratorio che suggerisccano altre infrequenti patologie neuroendocrine. 5. Pazienti con sottili anormarmalità cliiche, o rilievi di laboratorio (ad esempio valori elevati di cromogranina A), che suggeriscano comunque una NET,6 pazienti precedentemente sottoposti a chirurgia, intesa come curativa di un NET. 7. Pazienti avviati a valutazione clinica in seguito al riscontro casuake di una lesione periduodenale e pamctratica, riscontrata acccidentalemnte in corso di ecigrafia diagnostica e con caratteristiche ultrasonografiche suggestive di NET. 8. pazienti affetti da metastasti da NET a primitibità ignota.
    E.4Principal exclusion criteria
    1. Patient unwilling, or unable to consent. 2. Pregnancy, or lactation. 3. Age < 18 years 4. Known diagnosis of duodeno-pancreatic NET. 5. Patients with concomitant life-threatening disease. 6. Patients who had already undergone any of the tests under investigation (MDCT, PET, EUS) in the last six months. In particular patients should be excluded from the study, when a lesion in the duodeno-pancreatic area, with characteristic suspicious for a NET, is incidentally diagnosed by any of the techniques object of the study, namely MDCT, PET, or EUS. 7. Patients who had previously undergone total gastrectomy or pancreasectomy will be included in the study, but they will not undergo EUS.
    1. rifiuto del consenso o incapacità a fornirlo; 2 gravidanza, allattamento 3 età &lt; 18 anni 4 diagnosi nota di NET duoeno-pancreatico 5 pzaziente con patologia a rischio immedeiato per la vita, 6 pazienti che sono già sottoposti ai test nei sei mesi precedenti 7 i pazienti che sono srari proposti a gastrectomia totale o a pancreasctomia totale saranno inlusi nello stdudio ma non eseguiranno EUS.
    E.5 End points
    E.5.1Primary end point(s)
    to compare accuracy of MDCT and PET in the diagnosis of primary duodeno-pancreatic NET, calculated on a patient basis.
    confrontare l'accuratezza della TC mutistrato multidetectore e della PET nella diagnosi dei NET primitivi duodeno-pancreatic, calcolate sulla base del singolo paziente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years
    3 anni
    E.5.2Secondary end point(s)
    1.Impact of PET.2.Operative characteristics of MDCT, EUS and PET, in the diagnosis of primary duodeno-pancreatic NET, calculated on a patient basis and on lesion basis. 3.Median diameter and ranges of lesions diagnosed by each techniques. 4.Changes in EUS findings, after disclosure of PET results.5.Operative characteristics of MDCT and PET in the diagnosis of secondary NET, calculated on a patient basis and on a lesion basis 6.Incidence of secondary lesions, according to the T of the primary tumour.7.Diagnosis of new lesions during the follow up.8.Incidence of adverse events of the technique under investigation 9. Accuracy of EUS-FNA, according to the histological diagnosis (when available) and/or to the clinical follow
    1.Impatto della PET.2.Caratteristiche operative della MDCT, dell'EUS e della nella diagnosi delle lesioni primitive duodeno-pancreatiche, valuatate rispettivamente sulla base del paziente e delle lesioni. 3 Diametro mediano e range del diametro delle lesioni diagnsoticate da ciascuna tecnica.4.Modifica dei reperti della EUS dopo aver conosciuto il risultato della PET. 5.Caratteristiche operative della MDCT e della PET, nella diagnosi di lesioni secondarie, calcolate sulla base del paziente e della singola lesione. 6. Incidenza di lesioni secondarie, in accordo con il T della lesione. 7 Diasnosi di nuove lesioni durante il follow up.8.Incidence di eventi avversi 9 Accuratezza dell'EUS-FNA, in riferimentio alla diagnosi istologicica o al follow up clinico,
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    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 Yes
    E.6.5Efficacy Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States Yes
    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 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
    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.1.1Number of subjects for this age range: 0
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 2012-03-29. 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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 142
    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)
    The treatment will be according to the common clinical practice.
    Il trattamento sarà conforme alla comune pratica clinica.
    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 Decision2011-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-17
    P. End of Trial
    P.End of Trial StatusOngoing
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