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    Summary
    EudraCT Number:2012-002513-19
    Sponsor's Protocol Code Number:2011/609-31/1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-002513-19
    A.3Full title of the trial
    68Ga-DOTATOC-PET/CT for diagnosis of neuroendocrina tumours
    68Ga-DOTATOC-PET/CT för diagnostik av neuroendokrina tumörer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PET imaging of neuroendocrine tumours
    PET-kamera undersökning av neuroendokrina tumörer
    A.4.1Sponsor's protocol code number2011/609-31/1
    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 SponsorKarolinska University Hospital Solna
    B.1.3.4CountrySweden
    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 supportKarolinska University Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital
    B.5.2Functional name of contact pointDept. Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska Sjukhuset Solna
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-171 76
    B.5.3.4CountrySweden
    B.5.4Telephone number+460707293581
    B.5.5Fax number+460851771621
    B.5.6E-mailhans.jacobsson@karolinska.se
    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-DOTATOC
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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.3.9.3Other descriptive name68Ga-1,4,7,10-tetraazacyclo-dodecane-1,4,7,10-tetraacetic acid-D-Phe1-Tyr3-
    D.3.9.4EV Substance CodeSUB09417MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number120
    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
    Neuroendocrine tumour
    Neuroendocrin tumör
    E.1.1.1Medical condition in easily understood language
    Neuroendcrine tumours emanate from endocrine cells, most commonly in the small bowel, broncho-pulmonary system and colon and give hormonal symptoms in half of the patients.
    Neuroendokrina tumörer uppstår i spridda endokrina celler, vanligen i tunntarm, lunga-luftrör och tjocktarm. Cirka hälften av patienterna med neuroendokrina tumörer har hormonella symptom.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is an exploratory observational Phase II trial to investigate the imaging capacity of 68Ga-DOTATOC-PET/CT in patients with neuroendocrine tumours and medullary thyroid cancer in comparison with either Whole-Body-Magnetic Resonance Imaging using Diffusion Weighted Signal sequences (DWI-MRI) and in comparison with conventional radiological procedures such as CT and US and long term follow-up.
    Detta är en explorativ Fas II studie för att pröva den diagnostiska kapaciteten hos 68Ga-DOTATOC-PET/CT i patienter med neuroendokrina tumörer i jämförelse med helkroppsundersökning med magnetkamera med s.k. diffusionsviktade registreringar och i jämförelse med konventionella radiologiska metoder såsom CT och ultraljud samt med radiologisk och klinisk långtidsuppföljning.
    E.2.2Secondary objectives of the trial
    There are no secondary endpoints in this trial
    Det finns inga secondary endpoints i denna kliniska prövning
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with neueoendocrine tumour in need of somatostatin receptor imaging for staging of the disease, depiction of the primary tumour and patients with medullary thyroid cancer in need for pre-operative lymph node mapping.
    Patienter med neuroendokrin tumör med behov av
    somatostatinreceptoravbildning för stadieindelning av sjukdomen,
    diagnostik av primärtumören och patienter med medullär
    thyroideacancer i behov av preoperativ kartläggning av
    lymfkörtelmetastasering.
    E.4Principal exclusion criteria
    Age less than 18 years
    Claustrofobia
    Ålder yngre än 18 år
    Klaustrofobi
    E.5 End points
    E.5.1Primary end point(s)
    When both PET/CT and WB-MRI has been performed and compared and correlated to findings at surgery, histopathology and radiological and clinical follow-up
    När både PET/CT och WB-MRT har utförts och jämförts och korrelerats till resultat vid kirurgi, histopatologi och radiologisk och klinisk uppföljning.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Varying, because some patients undergo surgery and histopathology immediately after PET/CT and MRI and others needs to be followed radiological and clinically for longer time.
    Varierande eftersom vissa patienter genomgår kirurgi och histopatologi omgående och andra patienter behöver följas lång tid radiologisk och kliniskt.
    E.5.2Secondary end point(s)
    There are no secondary endpoints in this trial
    Det finns inga secondary endpoints i denna pröving.
    E.5.2.1Timepoint(s) of evaluation of this end point
    There are no secondary endpoints in this trial
    Det finns inga secondary endpoints i denna pröving.
    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 Yes
    E.8.1.7.1Other trial design description
    Explorativ
    Exploratory observational
    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 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
    The trial ends when PET/CT and WB-MRI has been performed and
    compared and correlated to findings at surgery, histopathology and
    radiological and clinicalfollow-up.
    Studien avslutas när PET/CT och WB-MRT utförst och jämförts och
    korrelerats mot radiologisk och klinisk uppföljning.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state600
    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)
    None
    Inga
    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 Decision2012-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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