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    Summary
    EudraCT Number:2018-002917-36
    Sponsor's Protocol Code Number:EMEA-000882-PIP03-11
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-09-01
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2018-002917-36
    A.3Full title of the trial
    A phase IV, monocentric, open-label, single-arm, dosimetry study of Rubidium (82Rb) chloride injection, administered as tracer for Positron Emission Tomography (PET) in paediatric patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    82Rubidium uptake and dosimetry in children
    Absorption et dosimétrie pédiatrique du 82Rubidium
    A.3.2Name or abbreviated title of the trial where available
    82Rubidium uptake and dosimetry in children
    Absorption et dosimétrie pédiatrique du 82Rubidium
    A.4.1Sponsor's protocol code numberEMEA-000882-PIP03-11
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/144/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJubilant DraxImage Inc.
    B.1.3.4CountryCanada
    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 supportJubilant DraxImage Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJubilant DraxImage Inc.
    B.5.2Functional name of contact pointRegulatory affairs
    B.5.3 Address:
    B.5.3.1Street Address16751 Trans-Canada Highway
    B.5.3.2Town/ cityKirkland
    B.5.3.3Post codeQC H9H 4J4
    B.5.3.4CountryCanada
    B.5.4Telephone number+15146948220
    B.5.5Fax number+15146949295
    B.5.6E-mailHSoulaihi@jdi.jubl.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 RUBY-FILL®
    D.2.1.1.2Name of the Marketing Authorisation holderJubilant Pharmaceuticals NV-Belgium
    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.3.4Pharmaceutical form 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 INNRUBIDIUM CHLORIDE RB-82
    D.3.9.1CAS number 132486-03-4
    D.3.9.3Other descriptive nameRUBIDIUM CHLORIDE RB-82
    D.3.9.4EV Substance CodeSUB185166
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number10
    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 Yes
    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
    Myocardial ischemia
    E.1.1.1Medical condition in easily understood language
    Myocardial ischemia occurs when blood flow to the heart is reduced, preventing the heart muscle from receiving enough oxygen.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028601
    E.1.2Term Myocardial ischemia
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a paediatric dosimetry study of Rubidium (82Rb) chloride injection. The main objectives of the trial are
    - To compare paediatric and adult time-integrated activity coefficients (ã) of 82Rb chloride
    - To confirm that estimates of paediatric radiation doses based on adult ã are comparable to estimates based on paediatric ã
    - To estimate paediatric dosimetry data of rubidium 82Rb chloride
    - To determine the safety and tolerability of 82Rb chloride administered intravenously
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Male or female aged from 1 month to less than 18 years of age at the time of signing consent/assent
    b. Patients in whom myocardial perfusion imaging with 82Rb chloride PET scan is clinically indicated (patients that may already have had 82Rb PET scan imaging in the past, for any reason, can be included in the study)
    c. Fully informed and signed consent from parent(s)/legal representative for all age groups prior to any study-related procedures. Patient consent will be obtained as of the age of 14, in accordance with Swiss regulations
    d. An understanding, ability, and willingness, or respectively in children unable to speak, absence of continuous adverse behavior, to fully comply with study procedures and restrictions, including if warranted, sedation or anesthesia
    e. Females of child-bearing potential must have a negative urine pregnancy test at day of imaging procedure
    E.4Principal exclusion criteria
    a. History of organ-removal surgery (e.g., nephrectomy, cholecystectomy, or splenectomy)
    b. Presence of any concurrent disease, condition or treatment, which, in the investigator’s opinion would interfere with study participation or confound the results of the study, e.g.: renal failure, severe uncontrolled asthma.
    c. Known hypersensitivity to 82Rb chloride or its excipients
    d. Contra-indication to sedation/anaesthesia
    e. Insufficient venous access
    f. Contra-indication to pharmacological stress (adenosine): decompensated asthma, STEMI <48h, symptomatic bradycardia, second- or third-degree heart block or Sick sinus syndrome (without a pacemaker), hypersensitivity to adenosine
    g. Unable to undergo PET scan assessment, e.g.: claustrophobia
    h. Within 30 days prior to screening visit, use of experimental or unregistered drugs that may affect the study outcomes
    i. Pregnancy or breast feeding
    j. Contra-indication to aminophylline: Known hypersensitivity to aminophylline, theophylline, ethylenediamine or one of its excipients, acute coronary thrombosis, acute tachycardia
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will evaluate organ radiation absorbed doses
    and effective dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all patients had the PET/CT scans with rubidium (82Rb) chloride
    E.5.2Secondary end point(s)
    - Time-integrated activity coefficients (ã) calculated for all organs
    imaged
    - Paediatric (ã) compared to adult values
    - Organ radiation doses for all paediatric phantoms calculated by OLINDA/EXM V1.1 for each patient’s data set
    - Mean radiation dose for the paediatric phantoms based on paediatric input data and compared to those previously calculated based on adult
    data
    - Effective dose coefficients (e) and effective dose (ED) calculated using both ICRP 60 (1) and ICRP 103 (2) tissue weightings and definition
    - Safety and tolerability of 82Rb chloride administered intravenously
    E.5.2.1Timepoint(s) of evaluation of this end point
    Same as primary endpoint
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Switzerland
    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.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 3
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) No
    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 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 2019-09-01. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    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
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Switzerland
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