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    Summary
    EudraCT Number:2010-022730-91
    Sponsor's Protocol Code Number:BR1-130
    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:2011-06-21
    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 number2010-022730-91
    A.3Full title of the trial
    Characterization of focal liver lesions with Sonovue(R)-enhanced
    ultrasound imaging: a phase III, intrapatient comparative study versus
    unenhanced ultrasound imaging using histology or combined
    imaging/clinical data as truth standard.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Characterization of focal liver lesions with Sonovue(R)-enhanced
    ultrasound imaging: a phase III, comparison in the same patient against unenhanced ultrasound imaging using histology or combined
    imaging/clinical data as truth standard.
    A.4.1Sponsor's protocol code numberBR1-130
    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 SponsorBracco Imaging S.p.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBracco Imaging S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBracco Imaging S.p.A.
    B.5.2Functional name of contact pointAlessandra D'Aponte
    B.5.3 Address:
    B.5.3.1Street AddressVia XXV Aprile, 4
    B.5.3.2Town/ citySan Donato Milanese
    B.5.3.3Post code20097
    B.5.3.4CountryItaly
    B.5.4Telephone number+390221772495
    B.5.6E-mailalessandra.daponte@bracco.com
    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 International B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 2551-62-4
    D.3.9.2Current sponsor codeSonoVue
    D.3.9.3Other descriptive nameSULFUR HEXAFLUORIDE
    D.3.9.4EV Substance CodeSUB15925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µl/ml microlitre(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 Yes
    D.3.11.13.1Other medicinal product typeultrasound contrast agent
    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
    At least one focal liver lesion requiring further work-up for complete characterization.
    E.1.1.1Medical condition in easily understood language
    Subjects must have at least one liver lesion.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10024718
    E.1.2Term Liver tumor NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the sensitivity and specificity of Sonovue-enhanced
    ultrasound is superior to that of unenhanced ultrasound for the
    characterization of benign versus malignant focal liver lesions (FLLs)
    using final diagnosis based on histology or combiend imaging (CE-CT
    and/or CE-MRI)/clinical data as truth standard.
    E.2.2Secondary objectives of the trial
    1. to evaluate the accuracy and other performance parameters (positive
    predictive value, negative predictive value of Sonovue-enhanced
    ultrasound for characterization of benign versus malignant- FLLs in
    comparison to unenhanced ultrasound
    2. to evaluate the ability of Sonovue-enhanced ultrasound to obtain a
    specific diagnosis of FLLs in comparison to unenhanced ultrasound.
    3. to evaluate the inter-reader agreement in ultrasound images
    assessment (unenhanced and Sonovue-enhanced separately)
    4. to provide evidence of the safety and tolerability of intravenously
    administered Sonovue in subjects with focal liver disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male/Female.
    - Provides written Informed Consent and is willing to comply with
    protocol requirements.
    - Is at least 18 years of age.
    - Has at least 1 FLL (target lesion) requiring work-up for characterization. Target lesion may include : Incidentally detected, in
    subjects with chronic hepatitis or liver cirrhosis, in subjects with known
    history of malignancy.
    - Is scheduled for surgical removal or biopsy of the target lesion from
    24h to 30 days after the Sonovue administration OR in case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a CE-CT and/or CE-MRI of the target lesion from 30 days to 48h prior to or from 24h to 30 days after the administration of Sonovue.
    E.4Principal exclusion criteria
    -Has an acoustic window insufficient for adequate ultrasound
    examination of the liver.
    - Has a FLL that cannot be identified with unenhanced ultrasound.
    - Has received or is scheduled for antineoplasic chemotherapy or an
    invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.
    - Is receiving any other contrast medium, within the 48h before and up
    to 24h following the administration of Sonovue.
    - Known right to left cardiac shunt, bidirectional or transient.
    - Has any allergy to 1 or more ingredients of the investigational product.
    - Has received an investigational compound within 30 days before
    admission into this study
    - Has any contraindication to 1 of the planned imaging procedures
    (implants, claustrophobia, etc.)
    - Has any medical condition or other circumstances which would
    significantly decrease the chances of obtaining reliable data, achieving
    this study objectives, or completing the study and/or post-dose followup examinations.
    - Is a pregnant or lactating female.
    E.5 End points
    E.5.1Primary end point(s)
    The sensitivity of Sonovue-enhanced ultrasound is superior as compared to unenhanced ultrasound for at least 2 of the 3 off-site assessors analyzing their data separately.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After clinical evaluation by 3 off-site assessors.
    E.5.2Secondary end point(s)
    The specificity of Sonovue-enhanced ultrasound is superior as compared to unenhanced ultrasound for at least 2 of the 3 off-site assessors analyzing their data separately.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After clinical evaluation by 3 off-site assessors.
    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 Yes
    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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Germany
    United States
    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 visit of the last subject undergoing the trial.
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 246
    F.1.3Elderly (>=65 years) No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 246
    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 for that condition.
    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 Decision2011-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-29
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