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    Summary
    EudraCT Number:2020-002868-31
    Sponsor's Protocol Code Number:68Ga-DFO-B-I/IIa
    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:2020-09-16
    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 number2020-002868-31
    A.3Full title of the trial
    A Phase I/IIa study to evaluate safety, biodistribution, dosimetry and preliminary diagnostic performance of [68Ga]Ga-Deferoxamine for PET imaging in patients with bacterial infections
    Phase I/IIa Studie 68Ga–Deferoxamin für die PET Untersuchung bei bakteriellen Infektionen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Deferoxamine, labelled with radioactive Gallium-68, for diagnosis of bacterial infections
    Mit Gallium-68 radioaktiv markiertes Deferoxamin für die Diagnose von bakteriellen Infektionen
    A.4.1Sponsor's protocol code number68Ga-DFO-B-I/IIa
    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.4.1Name of organisation providing supportLandeskrankenhaus Innsbruck - Tirol Kliniken
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Nuklearmedizin
    B.5.2Functional name of contact pointChefsekretariat
    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 number004351250422651
    B.5.5Fax number004351250422659
    B.5.6E-mailstudyoffice-nuclearmedicineInnsbruck@i-med.ac.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 name[68Ga]Ga-Deferoxamine
    D.3.4Pharmaceutical form Solution 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.3.8INN - Proposed INNDEFEROXAMINE MESILATE
    D.3.9.1CAS number 138-14-7
    D.3.9.2Current sponsor codedeferoxamine
    D.3.9.3Other descriptive nameDFO mesilate; Desferal
    D.3.9.4EV Substance CodeSUB01571MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[68Ga]Ga DEFEROXAMINE
    D.3.9.1CAS number 70-51-9
    D.3.9.2Current sponsor code[68Ga]Ga-Deferoxamine
    D.3.9.3Other descriptive name68Ga-DFO
    D.3.9.4EV Substance CodeSUB06942MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 150
    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
    Upper/lower respiratory tract bacterial infections or orthopaedic bacterial infections
    E.1.1.1Medical condition in easily understood language
    bacterial infections of the respiratory tract and infections of orthopaedic implants
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    Primary objectives:
    1. Safety and tolerability [68Ga]Ga-Deferoxamine in human subjects
    2. Preliminary diagnostic sensitivity of [68Ga]Ga-Deferoxamine
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    1. Radiation dosimetry of [68Ga]Ga-Deferoxamine in human subjects
    2. To characterise the pharmacokinetics of [68Ga]Ga-Deferoxamine in human subjects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures.
    2 Age > 18 years.
    3 Patients with bacterial infections (e.g. Pseudomonas aeruginosa, Staphylococcus spp., Streptococcus spp., etc. of any region except the urinary tract) or patients with infections of implanted devices (e.g. orthopaedic or vascular implants, pacemakers, catheters, etc.).
    4 Strong clinical indication or confirmation of bacterial infection with typical alterations of laboratory markers (ESR, CRP, and/or leucocyte number). If microbiologically confirmed, the bacterial spectrum must be available. If not microbiologically confirmed, any available microbiology samples before antibiotic treatment should be stored for following studies on [68Ga]Ga-Deferoxamine uptake in vitro.
    5 Participating men must use a single barrier method for contraception for 1 month after completion of the trial starting at the day of application of [68Ga]Ga–Desferoxamine.
    6 Women of childbearing age must use two highly effective methods of contraception during the trial and 6 months after application of investigational product if not in menopause or after hysterectomy.
    E.4Principal exclusion criteria
    1 Pregnancy; breast-feeding; females planning to bear a child recently or with childbearing potential, unless a commonly accepted effective means of contraception is used.
    2 Patients with cystic fibrosis (CF)
    3 Patients having a confirmed bacterial infection with a bacterial spectrum that is known to lack uptake of [68Ga]Ga-Deferoxamine (e.g. E.coli)
    4 Patients under therapy with Deferoxamine (Desferal®) or other metal chelators.
    5 Patients with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic inflammation (e.g. Inflammatory Bowel Disease).
    6 Any other concurrent severe and/or uncontrolled and/or unstable medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
    7 Known or expected hypersensitivity to Ga-68 or Deferoxamine (Desferal®).
    8 Prior administration of a radiopharmaceutical for PET-imaging within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical.
    9 Subjects with any kind of dependency on the investigator or are employed by the sponsor or investigator.
    10 Participation in any other investigational trial within 30 days of study entry with potential interactions regarding the study drugs or the underlying disease.
    11 History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
    12 Patients with iron overload disease.
    13 Patients with glomerular filtration rate below 30 ml/min/1,73 m2 where primarily renal excretion of Ga-68 or Deferoxamine could be impaired.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    1. Number of participants with adverse events as a measure of safety and tolerability after [68Ga]Ga-Deferoxamine injection and PET/CT scanning, as per CTCAE (v5.0).
    2. Diagnostic sensitivity of [68Ga]Ga-Deferoxamine defined as quantitative measurement of standardised uptake values (SUVs) of bacterial lesions.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Completion of 15 patients
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    1. Radiation dosimetry of [68Ga]Ga-Deferoxamine in human: estimation of the organ absorbed doses and effective dose from [68Ga]Ga-Deferoxamine PET/CT scan.
    2. Pharmacokinetic calculations: Quantification of urinary excretion and half-life in blood of [68Ga]Ga-Deferoxamine
    3. Description of [68Ga]Ga-Deferoxamine accumulation in bacterial lesions (number of lesions, SUV value per lesion).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoint 1 and 2: Completion of 4 patients
    Secondary Endpoint 3: Completion of all 15 patients
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 EEA2
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 15
    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 the underlying 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 Decision2020-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-11
    P. End of Trial
    P.End of Trial StatusOngoing
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