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    Summary
    EudraCT Number:2013-002526-23
    Sponsor's Protocol Code Number:68GaPET-Meningioma-2013
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-12-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-002526-23
    A.3Full title of the trial
    Impact of 68Ga-DOTAOTC PET for diagnosis of newly diagnosed or recurrent meningiomas
    Einfluss der 68Ga-DOTATOC PET zur Diagnostik von neudiagnostizierten bzw. rezidivierenden Meningeomen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation to understand the significance of a new nuclear medicine imaging technique (68Ga-DOTAOTC PET) for diagnosis of newly diagnosed or recurrent brain tumors originating in the arachnoid membrane (meningiomas)
    Untersuchung des Stellenwerts einer neuen nuklearmedizinischen Bildgebung (68Ga-DOTAOTC PET) zur Diagnostik neu aufgetretener oder bereits bekannter Hirntumore, welche von der Gehirnhaut ihren Ursprung nehmen (Meningeome)
    A.4.1Sponsor's protocol code number68GaPET-Meningioma-2013
    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 SponsorMedizinische Universität Innsbruck
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Innsbruck
    B.5.2Functional name of contact pointMedizinische Universität Innsbruck
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number0043512504 22651
    B.5.5Fax number0043 512504 22659
    B.5.6E-mailirene.virgolini@uki.at
    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.3.2Product code 68Ga-DOTATOC
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor code68Ga-DOTATOC
    D.3.9.3Other descriptive name68Ga-DOTA-DPhe1, Tyr3-octreotide
    D.3.9.4EV Substance CodeSUB09417MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 70
    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
    Based on the finding that meningiomas express somatostatin-receptor 2 (SSTR2), PET imaging with SSTR ligands like 68Ga-DOTATOC has been proposed as a more specific method. Currently, the role of SSTR-based imaging for meningioma diagnosis and treatment is still unclear. Therefore the accuracy of MRI and 68Ga-DOTATOC-PET for meningioma diagnosis at initial presentation, to determine residual tumor postoperatively and recurrence during follow-up will be investigated.
    Aufgrund der Tatsache, dass Meningeome großteils Somatostatin Rezeptoren vom Subtyp 2 exprimieren, wurden radioaktive Somatostatin Analogas wie zB 68Ga-DOTATOC entwickelt, welche spezifisch an diese Rezeptoren binden. Mit dem Einsatz einer PET kann das Meningeom zur Darstellung gebracht werden. Zusammen mit der MRT kann die PET komplementäre Informationen liefern. Diesbezüglich soll der Stellenwert der 68Ga-DOTATOC-PET im Vergleich zur MRT prä/postoperativ sowie im Follow up untersucht werden.
    E.1.1.1Medical condition in easily understood language
    Investigation of the significance of a new nuclear medicine imaging technique using radioactive substance for tumor assessment before and after surgery and during follow up visits compared to MRI
    Untersuchung des Stellenwerts der neuen nuklearmedizinischen Bildgebung (68Ga-DOTAOTC PET) vor und nach der Operation und in der Verlaufskontrolle verglichen mit der Standard MRT
    E.1.1.2Therapeutic area Not possible to specify
    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
    The primary aim of this proposed study is to compare the accuracy of MRI and 68Ga-DOTATOC-PET for primary diagnosis and assessment of residual tumor after surgery, their value for follow up visits and to diagnose tumor progression.
    Das Primäre Studienziel ist die Ermittlung der diagnostischen Genauigkeit der 68Ga-DOTATOC-PET verglichen mit der standard cerebralen kontrastmittelverstärkten MRT prä-, postoperativ und im Follow-up.
    E.2.2Secondary objectives of the trial
    As a secondary study objective, a direct comparison between SSTR2 expression in tumor tissue and 68Ga-DOTATOC uptake as well as immunhistochemical analysis of other biologically relevant hormone and growth factor receptors will be investigated with regard to improve diagnosis and treatment planning of meningiomas.

    Additionally, the tumor volumes in cerebral MRI sequences using contrast agent and metabolic tumor volumes in 68Ga-DOTATOC PET will be measured. Following this, overlap analysis of the measured volumes will be performed.
    Ein sekundäres Studienziel ist der Vergleich der 68Ga-DOTATOC-PET mit der immunhistochemischen SSTR2 Darstellung im Tumorgewebe sowie die Analyse weiterer biologisch relevanter Hormone und Wachstumsfaktorrezeptoren mit dem Ziel, die Tumordiagnostik und die Therapieplanung zu verbessern.

    Desweiteren werden prä- und postoperativ sowie im Follow up gemessene Tumorvolumina in der cerebralen kontrastmittelverstärkten MRT und 68Ga-DOTATOC-PET mittels Tumorvolumetrie berechnet. Anschließend werden beide Volumina verglichen und der Grad der Übereinstimmung mittels Overlapanalyse bestimmt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The patient must be ≥ 18 years and ≤ 75 of age
    - MRI with suspicion of meningeal tumor and imperative necessity of resection
    OR
    MRI with confirmation of progressive disease of known and histological verified meningeal tumor (ICD-codes D32.0 and C70.0) and imperative necessity of resection
    - The patient must have an ECOG performance status 0-2
    - Signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment
    - Männliche und weibliche Patienten im Alter von 18 bis 75 Jahren
    - MRT mit bildgebendem Verdacht auf ein Meningeom und Notwendigkeit zur chirurgischen Resektion
    ODER
    MRT mit bildgebender Bestätigung eines Tumorrezidivs eines bekannten und histologisch gesicherten Meningeoms (ICD-Codes D32.0 und C70.0) und Notwendigkeit zur chirurgischen Resektion
    - ECOG 0-2
    - Schriftliche Einwilligung des Patienten nach erfolgter Aufklärung
    E.4Principal exclusion criteria
    - Anamnestic known hypersensitivity or side effects of accomplished 68Ga-DOTATOC-PET prior to study enrollment
    - ECOG >2
    - The patient is active participant in another clinical trial, which investigates diagnostic and treatment of meningeal tumors
    - Other severe acute or chronic medical or psychiatric condition that would impart excess risk associated with study participation or which would make the patient inappropriate for entry into this study. The decision to enroll the patient in this study is in the judgment of the investigator
    - Pregnancy and Breastfeeding:
    Female patients who are pregnant or nursing
    - Evidence of incompliance of the patient to not comply with scheduled visits, treatment plans, laboratory test and other study procedures
    - Prior therapy with Octreotid or prior chemotherapy/local radiotherapy within the last 4 weeks
    - Anamnestisch bekannte Überempfindlichkeit bzw. Nebenwirkungen gegenüber einer bereits durchgeführten 68Ga-DOTATOC PET
    - ECOG >2
    - Teilnahme des Patienten an einer anderen klinischen Studie, welche die Diagnostik und die Therapie von Meningeomen untersucht
    - Sucht- oder sonstige Erkrankungen, die es dem Betreffenden nicht erlauben, Wesen und Tragweite sowie mögliche Folgen der klinischen Prüfung abzuschätzen
    - Schwangere oder stillende Frauen
    - Anzeichen darauf, dass der Patient den Prüfplan voraussichtlich nicht einhalten wird (z. B. mangelnde Kooperationsbereitschaft)
    - Vorangegangene Therapie mit Octreotid oder eine Chemotherapie/lokale Strahlentherapie in den letzten 4 Wochen
    E.5 End points
    E.5.1Primary end point(s)
    Determination of diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) as well as signal activity of cerebral MRI T1 sequences using contrast agent (contrast enhancement, CE) and 68Ga-DOTATOC-PET (Standardized Uptake Values, SUV) prior and post surgery and follow up visits
    Bestimmung der diagnostischen Genauigkeit (Sensitivität, Spezifität, positiver und negativer prädiktiver Wert) bzw. der Signalaktivität in der der standard cT1-gewichteten kontrastmittelverstärkten MRT (contrast enhancement, CE) und in der 68Ga-DOTATOC-PET (Standardized Uptake Values, SUV) vor und nach chirurgischer Resektion und im Follow up
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the primary end point will be performed after last study patient has finished Follow Up Visite 2.
    Die Evaluierung des primären Endpunkts wird durchgeführt, nachdem der letzte Studienpatient die Follow up Visite 2 abgeschlossen hat.
    E.5.2Secondary end point(s)
    Correlation between metabolic activity of 68Ga-DOTATOC-PET (Standardized Uptake Values; SUV) and immunohistochemical SSTR analysis for quantitative assessment of receptor densitiy (immunoreactive score; IRS) as well as determination of Cut-off-values

    Comparison of measured tumor volumes (cm3) in MRI T1 sequences and metabolic tumor volumes in 68Ga-DOTATOC-PET pre- and postoperative as well as follow up followed by overlap analysis (Dice coefficient
    Korrelation der 68Ga-DOTATOC-PET Aktivität (Standardized Uptake Values; SUV) mit dem immunhistochemischen Nachweis der Somatostatin Rezeptorexpression (Färbeindex) und Bestimmung der Cut-off-Werte

    Vergleich der in der 68Ga-DOTATOC-PET und cT1 MRT gemessenen Tumorvolumina mittels prä-, postoperativ und im Follow-up durchgeführter Tumorvolumetrie (cm3) und Overlapanalyse (Dice coefficient)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Correlation analyses will be performed after the last study patient has undergone surgery (Study Visite 2)

    Comparison of measured tumor volumes will be performed, after last study patient has finished Follow Up Visite 2.
    Die Korrelationsanalyse wird durchgeführt, nachdem der letzte Studienpatient operiert wurde (Studienvisite 2)

    Der Vergleich der gemessenen Tumorvolumina wird durchgeführt, nachdem der letzte Studienpatient die Follow up Visite 2 abgeschlossen hat.
    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 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 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
    letzte Studienvisite des letzten Studienpatienten
    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 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state35
    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)
    Further diagnostic and therapeutic management will be performed within recommended guidelines.
    Die Weiterbehandlung der Patienten erfolgt im Rahmen der regulären Tumortherapie.
    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 Decision2014-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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