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    Summary
    EudraCT Number:2009-014737-24
    Sponsor's Protocol Code Number: 68GaPET-HNSCC-2009
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-20
    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 number2009-014737-24
    A.3Full title of the trial
    Vergleichende Studie zur Darstellung der Somatostatinrezeptoren bei Kopf-Hals-Tumoren mit Immunhistochemie und PET (68Ga-DOTA-Tyr3-Octreotid)
    A.3.2Name or abbreviated title of the trial where available
    SSTR in HNSCC: Vergleich von IHC und PET
    A.4.1Sponsor's protocol code number 68GaPET-HNSCC-2009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGa68-DOTA-Tyr3-Octreotid
    D.3.2Product code Ga68-DOTA-Tyr3-Octreotid
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameDOTA-Tyr3-Octreotide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameGa68
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number80 to 120
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 suffering from head and neck squamous cell carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Hauptzielkriteruim dieser Studie ist der klinisch-bildegebende Nachweis SSTR-positiver Plattenepithelkarzinome des Kopf-Hals-Bereichs mit der 68Ga-DOTA-Tyr3-Octreotid-PET. Das Ergebnis der PET-Untersuchung wird von einem erfahrenen Untersucher im Sinne einer Null-oder-Eins-Aussage interpretiert. Die statistische Auswertung erfolgt deskriptiv. Eine quantitative Auswertung der PET mittels Bestimmung des SUV ist möglich.
    E.2.2Secondary objectives of the trial
    Nebenzielkriterien sind die Überprüfung der Übereinstimmung mit dem immunhistochemischen Nachweis der SSTR 1-5 und Bestimmung der Cut-off-Werte. Hierbei werden die Übereinstimmungen der Untersuchungen mittels Cohens Kappa und Spearmans Rangkorrelationskoeffizient erfasst. Das Ansprechen der einzelnen Rezeptoren wird deskriptiv dargestellt. Die optimalen Cut-Off Werte für die Ausprägungen des immunhistochemischen Nachweises und der nuklearmedizinischen Untersuchungen werden mittels ROC analysiert. Eine multivariate Klassifikation erfolgt mittels Klassifikationsbäumen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eingeschlossen werden männliche und weibliche Patienten im Alter von 18 bis 70 Jahren mit histologisch gesicherten Ersterkrankungen der ICD-Codes C00-C14 und C32 und einem UICC Stadium > I (Mindesttumorgröße > 2 cm) an den beiden teilnehmenden Kliniken (HNO und MKG der MUI). Vorraussetzung ist die schriftliche Einwilligung des Patienten nach erfolgter Aufklärung.
    E.4Principal exclusion criteria
    · Anamnestisch bekannte Überempfindlichkeit gegenüber einem der eingesetzten Medikamente oder deren Inhaltsstoffe oder gegenüber Medikamenten mit ähnlicher chemischer Struktur
    · Teilnahme des Patienten an einer anderen klinischen Studie innerhalb der letzten 4 Wochen vor dem Einschluss
    · Sucht- oder sonstige Erkrankungen, die es dem Betreffenden nicht erlauben, Wesen und Tragweite sowie mögliche Folgen der klinischen Prüfung abzuschätzen
    · Schwangere oder stillende Frauen
    · Frauen im gebärfähigen Alter, außer Frauen, die die folgenden Kriterien erfüllen:
    - Post-menopausal (12 Monate natürliche Amenorrhoe oder 6 Monate Amenorrhoe mit Serum FSH > 40 mlU/ml)
    - Postoperativ (6 Wochen nach beidseitiger Ovarektomie mit oder ohne Hysterektomie)
    - Regelmäßige und korrekte Anwendung einer Verhütungsmethode mit Fehlerquote < 7 % pro Jahr (z. B. Implantate, Depotspritzen, orale Kontrazeptiva, Intrauterine Device – IUD). Dabei ist zu berücksichtigen, dass die kombinierte orale Kontrazeption – im Gegensatz zu reinen Progesteronpräparaten – eine Versagerquote von < 1 % hat. Hormonspiralen sind mit einem Pearl Index < 1 % sicherer als Kupferspiralen.
    - Sexuelle Enthaltsamkeit
    - Vasektomie des Partners
    · Anzeichen darauf, dass der Patient den Prüfplan voraussichtlich nicht einhalten wird (z. B. mangelnde Kooperationsbereitschaft)
    · Vorangegangene Therapie mit Octreotid in den letzten sechs Wochen
    · Patienten mit Leberzirrhose
    · Zweitmalignom
    · Vorangegangene Therapie mit Octreotid in den letzen sechs Wochen oder eine Chemotherapie/lokale Strahlentherapie in den letzten 4 Wochen
    E.5 End points
    E.5.1Primary end point(s)
    Primärer Endpunkt der Studie ist das Ergebnis der 68Ga-DOTA-Tyr3-Octreotid-PET. Das Untersuchungsergebnis wird von einem erfahrenen Untersucher interpretiert und liegt als Null-oder-Eins-Aussage vor.
    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) 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) 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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    Nach kumulativer immunhistochemischer Auswertung der letzten in die Studie eingeschlossenen Patienten. Dieser Zeitpunkt liegt daher nach der letzten Visite des letzten Patienten.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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.1.1.1In 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.1.3Elderly (>=65 years) Yes
    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 2010-10-20. 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 state50
    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 Decision2010-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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