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    Summary
    EudraCT Number:2010-022057-42
    Sponsor's Protocol Code Number:3D-iUS-NCH
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-25
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2010-022057-42
    A.3Full title of the trial
    Pilot study to optimise the use and to evaluate the diagnostic value of intraoperative contrast-enhanced 3D-ultrasound with SonoVue® for imaging of intracranial tumors
    Pilotstudie zur Optimierung des Einsatzes und zur Evaluierung der diagnostischen Wertigkeit des intraoperativen kontrastverstärkten 3D-Ultraschalls mit SonoVue® in der Tumordarstellung intrakranieller Tumore
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study to optimise the use and to evaluate the diagnostic value of intraoperative contrast-enhanced 3D-ultrasound with SonoVue® for imaging of intracranial tumors
    Pilotstudie zur Optimierung des Einsatzes und zur Evaluierung der diagnostischen Wertigkeit des intraoperativen kontrastverstärkten 3D-Ultraschalls mit SonoVue® in der Tumordarstellung intrakranieller Tumore
    A.4.1Sponsor's protocol code number3D-iUS-NCH
    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 SponsorUniversität Leipzig
    B.1.3.4CountryGermany
    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 supportDeutsche Forschungsgemeinschaft
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leipzig Neurochirurgie
    B.5.2Functional name of contact pointDr. Dirk Lindner
    B.5.3 Address:
    B.5.3.1Street AddressLiebigstraße 20
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number00493419717500
    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 Yes
    D.2.1.1.1Trade name SonoVue®
    D.2.1.1.2Name of the Marketing Authorisation holderBracco Altana Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSonoVue®
    D.3.2Product code SonoVue®
    D.3.4Pharmaceutical form Powder and solvent for suspension 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 No
    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
    Patients with an intracranial tumor and planned operation as well as expected echoic behaviour of the tumor
    Patienten mit gesicherter intrakranieller Raumforderung mit geplanter Operation und erwarteter Echogenität
    E.1.1.1Medical condition in easily understood language
    Patients with an intracranial tumor and planned operation as well as expected echoic behaviour of the tumor
    Patienten mit gesicherter intrakranieller Raumforderung mit geplanter Operation und erwarteter Echogenität
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10053764
    E.1.2Term Brain tumor operation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of intraoperative, 3D reconstructed and contrast enhanced, transdural ultrasound with the preoperative 3D- MRi as Gold Standard.

    Comparison of intraoperative, 3D reconstructed and contrast enhanced ultrasound after tumor resection to verify the extent of resection as well as accuracy of navigation with the early post operative3D- MRi as Gold Standard
    Vergleich des intraoperativen 3D-Ultraschalls mit bzw. ohne SonoVue® transdural zu Beginn der Operation mit der präoperativen 3D-MRT als Goldstandard in der Darstellung von Tumorgrenzen.
    Vergleich des intraoperativen 3D-Ultraschalls mit bzw. ohne SonoVue® zur Navigations- und Resektionskontrolle mit der postoperativen 3D-MRT als Goldstandard in der Darstellung von Tumorgrenzen.
    E.2.2Secondary objectives of the trial
    1) Can the use of SonoVue® improve imaging in 3D ultrasound of brain tumors? Are there differences in the quality of imaging in pre- and postoperative ultrasound?
    2) Could the 3D reconstructed and contrast enhanced ultrasound figure the intraoperative brainshift correlate to anatomical structures?
    3) How does the 3D reconstructed and contrast enhanced ultrasound with SonoVuo® figures the tumor in different tumor entities?
    (1) Wird die Darstellung intrakranieller Tumore im 3D-Ultraschall durch die Anwendung von SonoVue® verbessert? Gibt es prä- und postoperativ evtl. differentielle Unterschiede im erwarteten Zugewinn an Darstellungsqualität?
    (2) Kann durch den SonoVue® kontrastverstärkten 3D-Ultraschall die intraoperative Brainshift im Bereich des Tumors in Beziehung zu angrenzenden Arealen/Gefäßen dargestellt werden?
    (3) Wie variiert die Aussagekraft des kontrastverstärkten 3D-Ultraschalls mit SonoVue® in der Tumorresektion bei verschiedenen Tumorentitäten?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    – signed informed consent of the patient
    – age ≥ 18 years
    – Patients with an intracranial tumor and planned operation as well as expected echoic behaviour of the tumor.
    – Ensured tumor in cranial MRi
    I) Astrocytic tumors
    II) Oligodendroglioma
    III) Ependymoma
    IV) Plexus choroidea Tumors
    V) Pineal Tumors
    VI) Embryonal Tumors
    VII) Meningeal Tumors
    VIII) Lymphoma
    IX) Tumors of the Sella
    X) Metsatasis
    – Schriftliche Einwilligung des Patienten oder des gesetzlichen Betreuers liegt vor
    – Alter ≥ 18 Jahre
    – Patienten mit gesicherter intrakranieller Raumforderung mit geplanter Operation und erwarteter Echogenität
    – In der MRT (Befund durch unabhängigen Neuroradiologen bestätigt) Verdacht auf eine der unten genannten Tumorentität einschließlich Rezidive:
    I) Astrozytäre Tumoren
    II) Oligodendrogliale Tumoren, Mischgliome
    III) Ependymale Tumoren
    IV) Choroidalplexustumoren
    V) Pinealisparenchymtumoren
    VI) Embryonale Tumoren
    VII) Meningeale Tumoren
    VIII) Lymphome
    IX) Tumoren der Sellaregion
    X) Metastasen
    E.4Principal exclusion criteria
    – ASA 4 classificated patient
    – Acute coronary syndrome
    – Acute angina pectoris
    – Disheveled Hypertension
    – Acute heart failure
    – NYHA III-IV
    – Pulmonarey hypertension (>90 mmHg)
    – Left-right reverals
    – Heart intervention briefer 2 weeks
    – Endocerditis
    – Need of dialysis
    – Hepatic insufficient
    – Acute Sepsis
    – ARDS (Acute Respiratory Distress Syndrom)
    – Acute respiratory distress
    – Allergy for SonoVue®
    – Allergy for coupling agent
    – Participation in other clinical trails
    – Pregnant or nursing women
    – No compliante patient
    – Actual drug abuse
    – Fertile women with no appropriate contraception or no longer than two years after the last menstruation
    – ASA 4 klassifizierter Patient
    – Akutes Koronarsyndrom
    – Instabile Angina Pectoris
    – Nicht einstellbarer Bluthochdruck
    – Akutes Herzversagen
    – Schwere Herzinsuffizienz (NYHA III – IV)
    – Pulmonale Hypertonie (>90 mmHg)
    – Rechts- Links- Shunt
    – Koronarintervention < 2 Wochen zurückliegend
    – Endokarditis
    – Patient dekompensiert oder dialysepflichtig
    – Leberinsuffizienz
    – akute Sepsis / Entzündung
    – ARDS (Acute Respiratory Distress Syndrom)
    – Akutes Atemnotsyndrom
    – Überempfindlichkeit gegen Schwefelhexafluorid oder SonoVue® generell
    – Allergien gegen Ultraschall-Gel
    – Teilnahme an anderen interventionellen Studien
    – Schwangere oder stillende Patientin
    – Mangelnde Kooperationsbereitschaft (Compliance)
    – Aktueller Drogenabusus
    – Fertile weibliche Patienten (letzte Menstruation <2 Jahre her) ohne angemessene kontrazeptive Maßnahmen (Implantate, Injektionen, orale Kontrazeptiva, intrauterine devices – Spiralen etc., vasektomierter Partner) während der Teilnahme an der Studie (Studienteilnehmerinnen, die eine hormonelle Methode der Kontrazeption nutzen, müssen über mögliche Einflüsse der Prüfpräparate auf die Kontrazeption informiert werden).
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of intraoperative, 3D reconstructed and contrast enhanced, transdural ultrasound in brain tumor operation to verify the accuracy in resection control as well as precision of navigation with the pre and postoperative 3D- MRi as Gold Standard
    Vergleich der Präzision in der Darstellung von Tumorgrenzen mit intraoperativem kontrastverstärkten 3D
    Ultraschall mit SonoVue® und prä- sowie postoperativer MRT als Goldstandard zur Navigations- und Resektionskontrolle
    E.5.1.1Timepoint(s) of evaluation of this end point
    During operation
    Während der Operation
    E.5.2Secondary end point(s)
    (1) Can the administration of SonoVue® improve the imaging of brain tumors? Are there pre- and postoperative differences in the expected improve of the imaging quality.
    (2) Can the SonoVue® contrast-enhanced ultrasound image the intraoperative brainshift in the area of the tumor in contrast to adjacent tissue and vessels?
    (3) How does the outcome of the SonoVue® contrast-enhanced ultrasound differ in dependance to the tumor entity?
    (1) Wird die Darstellung intrakranieller Tumoren im 3D-Ultraschall durch die Anwendung von SonoVue® verbessert? Gibt es prä- und postoperativ evtl. differentielle Unterschiede im erwarteten Zugewinn an Darstellungsqualität?
    (2) Kann durch den SonoVue® kontrastverstärkten 3D-Ultraschall die intraoperative Brainshift im Bereich des Tumors in Beziehung zu angrenzenden Arealen/Gefäßen dargestellt werden?
    (3) Wie variiert die Aussagekraft des kontrastverstärkten 3D-Ultraschalls mit SonoVue® in der Tumorresektion bei verschiedenen Tumorentitäten?
    E.5.2.1Timepoint(s) of evaluation of this end point
    During operation
    Während der Operation
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    Last subject last visit
    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 months5
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    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)
    normal treatment of condition
    standard Behandlung wie benötigt
    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 Decision2011-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-23
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