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    Summary
    EudraCT Number:2010-020482-24
    Sponsor's Protocol Code Number:1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-22
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-020482-24
    A.3Full title of the trial
    Ga-68-DOTATOC -PET in the management of pituitary tumours (PA) and Thyroid associated ophtalmopathy (TAO)
    Ga-68-DOTATOC PET i handläggningen av hypofystumörer (PA) och thyroidea associerad oftalmopati (TAO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation with PET in pituitary tumours and thyroid eye disease
    Undersökning med PET vid hypofystumörer och sköldkörtel relaterad ögonsjukdom
    A.3.2Name or abbreviated title of the trial where available
    Ga-PET in PA and TAO
    Ga-PET vid PA och TAO
    A.4.1Sponsor's protocol code number1
    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 Endocrinology, Sahlgrenska University Hospital
    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 supportSahlgrenska University Hospital/ Alf
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportFOU Västra Götalands region
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportNovo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAssar Gabrielssons Foundation
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportHenning ánd Ida Perssons foundation
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Nuclerar medicine, Sahlgrenska University Hospital
    B.5.2Functional name of contact pointPeter Gjertsson
    B.5.3 Address:
    B.5.3.1Street AddressBlå Stråket 5
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post codeSE-413 45
    B.5.3.4CountrySweden
    B.5.4Telephone number+46313428027
    B.5.6E-mailpeter.gjertsson@vgregion.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 nameGa-68-DOTATOC
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeradiopharmaceutical product
    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
    In this trial with Ga-68 DOTATOC two groupd of patients will be investigated - patients with pituitary adenoma (PA) and patients with thyroid associateed ophtalmopathy (TAO). As the eye muscles and the pituitary is in close located the PA patients will serve as controls for the TAO patients for the eye muscles and the TAO patietns will be controls regarding the pituitary for the PA patients
    I denna undersökning med Ga-68 DOTATOC så kommer 2 grupper av patienter bli undersökta - dels patienter med hypofystumör (PA) och patienter med thyroidea associerad oftalmopati (TAO). Eftersom hypofysen och ögonmusklerna ligger nära så komemr PA patienterna att vara kontroller för TAO patienterna avseende ögonmusklerna och TAO patienterna kommer att vara kontroller för PA patienterna avseende hypofysen
    E.1.1.1Medical condition in easily understood language
    Pituitary tumurs and thyroid related ophtalmopathy
    Hypofystumörer och sköldkörtel relaterad ögonsjukdom
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study if it is possible to detect pituitary tumours with GA-DOTADOC PET/CT by measuring the quantification of the accumulated amount of 68-Ga-DOTATOC.
    To evaluate the diagnostic accuracy of Ga-PET for orbital inflammation in comparison with clinical orbital evaluation and Magnetic resonance imaging (MRI)
    Att studera om det är möjligt att detektera hypofystumörer med Ga-PET genom att kvantifiera det ackumulerade upptaget av GA
    Att evaluera den diagnostiska tillförlitligheten av Ga-PET för orbital inflammation med klinisk orbital evaluering och MRI
    E.2.2Secondary objectives of the trial
    • To study if remaining tumour tissue can be differentiated in a better way than with MRI
    • To study if regrowth is earlier seen than conventional MRI
    • To study the histopathological findings of sst in the tumours and correlate it to the quantification of the accumulated amount of 68-Ga-DOTATOC
    • To study if it is possible to decide if remaining tissue postoperatively is scare tissue or tumour tissue by measuring quantification of the accumulated amount of GA-DOTATOC
    • To study if subtypes of pituitary tumours are detected differently with GA-DOTATOC
    • To study if pretreatment with Sandostatin enhances up-take of GA-DOTADOC (studied by quantification of the accumulated amount of tracer)
    • To study the pharmacokinetics of GA-DOTADOC in pituitary tumours
    Se ovan den engelska informationen
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Yes, the PET-TAO sis a substudy of an laready by the MPA approved study on rituximab treatment in steroid resitant patients with EUDRACT nr 2011-0008899-33. PET was not included in that study but is now added. The name of the study is Rituximab (RTX) therapy in steroid resistant patients or patients relapsing after intravenous steroids with active TAO-Rescue RTX protocol 2 (2011)
    Ja PET TAO är en substudie av en av Läkemedelsverket tidigare godkänd studie med EUDRACT nr 2011-0008899-33. PEt var inte inkluderat i den studien och det läggs nu till. Namnet på studien är Rituximab (RTX) therapy in steroid resistant patients or patients relapsing after intravenous steroids with active TAO-Rescue RTX protocol 2 (2011)
    E.3Principal inclusion criteria
    • Adult man or woman (over 18 years)
    • Naïve, unoperated pituitary tumour with GH or ACTH or TSH production or NFPA without treatment with somatostatin analogues or dopamine agonists OR
    • TAO with clinical activity score (CAS) of ≥ 4 (less than 3 months) and Euthyroid for at least 6 weeks
    Vuxen amn eller kvinna (över 18 år
    Hypofystumör med GH, ACTH, TSH produktion utan behandling med somatostatin analoger elelr dopaminagonister ELLER
    TAO patient med CAS ≥ 4 med euthyridism
    E.4Principal exclusion criteria
    • Patient who may not attend to the protocol according to the investigators opinion.
    • Pregnancy or lactating
    • Isolated prolactin producing tumours
    • Overproduction of FSH or LH
    • Carcinoids ie ectopic CRF production
    • Known or suspected allergy to the trial product or related products.
    • Dysthyroid optic neuropathy (DON)
    • Ulcerative Keratitis
    • Previous treatment with steroids for TAO (do not include prophylaxis for TAO in connection with radio iodine treatment)
    Se ovan
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measurement is the standardized uptake value (SUV in the region of interest (ROI) in the pituitary and the eye muscles in comparison with the MRI in in the case of TAOpatient with CASis the responder analysis in Clinical activity score (CAS) according to Mourrits et al
    Primära utfalls variabeln är standardiserat upptagsvärde (SUV) i intressanta regioner i hypofysen ch ögonmusklerna i jämförelse med MRI och när det gäller TAO patienter också CAS according to Mourits
    E.5.1.1Timepoint(s) of evaluation of this end point
    As this is an diagnostic investigation that will continously be evaluated the question is not appropriate
    Se ovan
    E.5.2Secondary end point(s)
    None
    Inga
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above
    Se ovan
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    Normal vävnad
    Normal tissue
    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.8.5The 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 last visit of the last subject undergoing the trial
    Se ovan
    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
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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 state80
    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 Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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