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    Summary
    EudraCT Number:2015-002225-19
    Sponsor's Protocol Code Number:FE001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-27
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-002225-19
    A.3Full title of the trial
    Ferumoxytol as an MR contrast agent in CNS and head & neck tumors, intracranial and peripheral vascular disease
    Ferumoxytol kontrasztanyagként való alkalmazása a központi idegrendszer, a fej-nyak régió, valamint az érrendszer MR vizsgálatában
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ferumoxytol as an MR contrast agent in CNS and head & neck tumors, intracranial and peripheral vascular disease
    Ferumoxytol kontrasztanyagként való alkalmazása a központi idegrendszer, a fej-nyak régió, valamint az érrendszer MR vizsgálatában
    A.4.1Sponsor's protocol code numberFE001
    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 SponsorDiagnostic Centre of Pécs
    B.1.3.4CountryHungary
    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 supportOregon Health and Science University
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiagnostic Centre of Pécs
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address2 Rét st.
    B.5.3.2Town/ cityPécs
    B.5.3.3Post codeH-7623
    B.5.3.4CountryHungary
    B.5.6E-mailinfo@neuroct.hu
    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 Feraheme
    D.2.1.1.2Name of the Marketing Authorisation holderAMAG Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Infusion
    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 Yes
    D.3.11.13.1Other medicinal product typeFerumoxytol is a colloidal iron-carbohydrate complex. It includes iron oxide particles with an iron oxide core surrounded by a polyglucose sorbitol-carboxymethylether shell.
    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
    Feraheme will be tested as an MRI contrast agent in the diseases of the central nervous system, in head and neck tumors and peripheral vascular diseases.
    E.1.1.1Medical condition in easily understood language
    Feraheme will be tested as an MRI contrast agent in the diseases of the central nervous system, in head and neck tumors and peripheral vascular diseases.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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 goal of the study is to test ferumoxytol as an MR contrast agent for imaging various diseases in the head and neck region, spine, including the central nervous system, in order to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical MR imaging.
    Besides this, the purpose of the study isto test the clinical value of high resolution steady state CBV maps.
    Since the potential clinical benefit of this new technique is due to its higher spatial resolution and distortion free parametric maps, the primary objective is to investigate the superiority of SS-CBV mapping over DSC-CBV in visualizing highly vascularized tumor areas.
    E.2.2Secondary objectives of the trial
    Secondary objectives include optimizing MR sequences and ferumoxytol injections to obtain absolute CBV values for steady state imaging and testing the association between rCBV and survival, the ability differentiating between progression and pseudoprogression, as well as histological correlation. We will also assess the delayed ferumoxytol enhancement in various stages of disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group specific inclusion criteria
    Group 1: Radiologic or histologic diagnosis of inflammatory, vascular, ischemic or demyelinizating disease of the central nervous system
    Group 2: Subjects must have a known or presumed radiological diagnosis of glioma or other malignant CNS disease. For presumed diagnosis of GBM, histological confirmation of GBM must be completed within 12 weeks of enrollment.
    Group 3: Subjects must have clinical or radiological diagnosis of enlarged cervical lymph nodes
    Group 4: Subjects must have presumed clinical or radiological diagnosis of peripheral vascluar disease

    Non-group specific inclusion criteria:
    • Subjects must be between 18 and 80 year old for inclusion in this study.
    • All subjects, or their legal guardians, must sign a written informed consent in accordance with institutional guidelines.
    • Subjects with a calculated GFR > 60 mL/min/1.73 m2 . (Calculation must be done using the National Kidney Disease Education Program’s website http://nkdep.nih.gov/lab-evaluation/gfr-calculators/adults-conventional-unit.asp )
    • Subjects must have a Karnofsky of 30% or greater.
    E.4Principal exclusion criteria
    1. Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.
    2. Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator’s Drug Brochure, 2009). Subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator’s discretion.
    3. Subjects who are pregnant or lactating or who suspect they might be pregnant.
    4. Subjects who have a contraindication for 3T MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material.
    5. Subjects with known iron overload (genetic hemochromatosis). In subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: Transferrin saturation (TS) test and Serum ferritin (SF) test. All associated costs will be paid by the study.
    6. Subject who have received ferumoxytol within 3 weeks of study entry.
    7. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints include four visualization variables to compare ferumoxytol vs gadolinium enhanced MRI scans and SS-CBV maps vs. DSC-CBV maps.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The MRI scans are going to be assessed continuously during the study. Statistical analysis is going to be performed after reaching the optimal subject number.
    E.5.2Secondary end point(s)
    The secondary endpoints include overall survival, rCBV values and ferumoxytol enhancement 24h after administration assessed at different disease stages.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The start observation time for overall survival will be the date of diagnosis.
    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 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 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 concerned4
    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
    Subjects may remain actively on study for up to 5 years or until all study visits are completed. Subjects will be removed from study for:
    •Grade 3 or greater allergic or immunologic reaction to either the gadoteridol or the study agent, ferumoxytol.
    •Calculated GFR < 60
    •If diagnosis is not confirmed
    •Subject request
    •For any reason, at the Investigator’s discretion
    After completing the study or being removed from the study, the subject will be followed for survival.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    All subjects, or their legal guardians, must sign a written informed consent and in accordance with institutional guidelines
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    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
    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 Decision2016-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
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