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    The EU Clinical Trials Register currently displays   36358   clinical trials with a EudraCT protocol, of which   5990   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-001807-35
    Sponsor's Protocol Code Number:S-20120206
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-001807-35
    A.3Full title of the trial
    Imaging with 111In-Octreotide SPECT-CT compared to 68Ga-DOTATATE PET-CT in patients admitted for evaluation of GastroEnteroPancreatic NeuroEndocrine Tumours, GEP-NETs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging with 111In-Octreotide SPECT-CT compared to 68Ga-DOTATATE PET-CT in patients admitted for evaluation of GastroEnteroPancreatic NeuroEndocrine Tumours, GEP-NETs
    A.3.2Name or abbreviated title of the trial where available
    OCDO-NET
    A.4.1Sponsor's protocol code numberS-20120206
    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 SponsorDepartment of Nuclear Medicine, Odense University Hospital
    B.1.3.4CountryDenmark
    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 supportDepartment of Nuclear Medicine, Odense University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Nuclear Medicine, Odense University Hospital
    B.5.2Functional name of contact pointJeppe Lauridsen
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Boulevard 29
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.6E-mailjeppe.kiilerich.lauridsen@rsyd.dk
    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 Yes
    D.2.1.1.1Trade name Octroscan
    D.2.1.1.2Name of the Marketing Authorisation holderMallinckrodt
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNA
    D.3.2Product code NA
    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 INNOCTREOTIDE
    D.3.9.1CAS number 83150-76-9
    D.3.9.4EV Substance CodeSUB09417MIG
    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 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.2.1.1.1Trade name 68Ga-DOTATATE is still in clinical development. Regulatory approval has not yet been obtained.
    D.2.1.1.2Name of the Marketing Authorisation holderN.A.
    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-DOTATATE
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    GastroEnteroPancreatic NeuroEndocrine Tumours (GEP-NET's)
    E.1.1.1Medical condition in easily understood language
    GastroEnteroPancreatic NeuroEndocrine Tumours (GEP-NET's)
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10062476
    E.1.2Term Neuroendocrine tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of diagnostic results obtained with the departments routine investigation for GEP-NETs performed with 111In-Octrotide SPECT-CT to a newly developed method using 68Ga-DOTATATE for PET-CT. The main purpose is to evaluate if the PET-CT method is at least as effective as the routine method with SPECT-CT.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients referred to the Department of Gastroenterology (dep. S), Odense University Hospital, with suspected GEP-NETs, will at their first appointment receive information about the clinical trial. Formal decision to participate may be made in relation to this information or by response to one of the involved physicians at Dept. S within 48 hours of having received the information. If the patient decides to participate, randomization is performed by the clinical physician at Dept. S to either the 111In-Octreotide SPECT-CT or 68Ga-DOTATATE PET-CT with the second examination to be performed within four weeks of the initial examination but with at least five days between the two examinations and prior to possible scheduled surgery. The physician performing the randomization sends a request to the Department of Nuclear Medicine (DNM), Odense University Hospital for both investigations with specification of the sequence as determined by the randomization. The patient is requested to bring the signed consent form when attending for the initial examination. To secure an even distribution between the sequence of the two imaging modalities throughout the trial, the patients are randomized in bulks of 2 and 2 with regards to either the 111In-Octreotide SPECT-CT or 68Ga-DOTATATE PET-CT being the initial examination.

    Patients are included only after written and oral information is given followed by the patients’ signed consent.
    Fertile women must on each examination day produce a negative pregnancy test prior to injection of the radiopharmaceuticals to remain included in the study.
    E.4Principal exclusion criteria
    Patients below 18 years of age, pregnant or nursing, unwilling, or unable to comply with the protocol or patients with hypersensitivity to any of the substances in the pharmaceuticals are excluded.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of 111In-Octrotide SPECT-CT to 68Ga-DOTATATE for PET-CT. Each examination is reported in the daily routine in the department and sent to the referring party as usual (primary evaluation). In this procedure each examination is reported by two separate nuclear medicine physicians responsible for the routine reporting of such examinations and with at least one having senior nuclear medicine expertise and experience in reading this type of examinations.
    The following trial-based evaluation (secondary evaluation) after the routine report is performed by a few selected physicians blinded to the set of images from the complementary examination, but not to information from other imaging modalities. The selected physicians for the secondary evaluation are not allowed to report examinations in the daily routine of included patients. In the secondary evaluation the same physicians are not allowed to describe both examinations of the same patient.

    Primary endpoint:
    a) a pathological finding divided into five categories;

    1) no pathology 2) predominantly no pathology 3) intermediate risk of pathology 4) predominantly certain pathology 5) certain pathology
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the imaging results is performed continuously
    E.5.2Secondary end point(s)
    Secondary endpoints:
    b) Is the finding a primary tumour or metastasis?
    c) Organs involved.
    d) Metastases per organ divided into four categories;

    1) 1 metastasis 2) 2-3 metastases 3) 4-5 metastases 4) > 5 metastases

    e) Pathological findings during a 1-year follow-up period based on clinical evaluation as well as other diagnostic modalities.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of the imaging results is performed continuously
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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) 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.8.5The 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 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
    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 months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 2013-08-22. 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 state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    Standard treatment plan
    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 Decision2013-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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