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    Summary
    EudraCT Number:2022-001811-16
    Sponsor's Protocol Code Number:PS21GAP
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-001811-16
    A.3Full title of the trial
    68Ga-SATO in pediatric neuroblastoma patient; exploratory, safety, non-randomized, open label, comparative study
    68Ga-SATO in pediatrische neuroblastoom patiënten; een verkennende, veiligheid, niet-gerandomiseerde, open label, vergelijkende studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating a new imaging technique for neuroblastoma
    Onderzoek naar een nieuwe beeldvormende techniek voor neuroblastoom
    A.3.2Name or abbreviated title of the trial where available
    GAP NBL
    GAP NBL
    A.4.1Sponsor's protocol code numberPS21GAP
    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 SponsorPrincess Maxima Center for pediatric oncology
    B.1.3.4CountryNetherlands
    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 supportPrincess Maxima Center for pediatric oncology
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportARICEUM Therapeutics
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrincess Maxima Center for pediatric oncology
    B.5.2Functional name of contact pointNuclear Medicine Physician
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 25
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CS
    B.5.3.4CountryNetherlands
    B.5.6E-maila.j.a.t.braat@umcutrecht.nl
    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 name68GA-SATOREOTIDE TRIZOXETAN
    D.3.2Product code 68GA-SSO120
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    Neuroblastoma
    Neuroblastoom
    E.1.1.1Medical condition in easily understood language
    Neuroblastoma
    Neuroblastoom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029260
    E.1.2Term Neuroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the short term safety and tolerability of 68Ga-SATO in pediatric
    patients with NBL
    Het beoordelen van de veiligheid en verdraagbaarheid op korte termijn
    van [68GA]-SATOREOTIDE TRIZOXETAN PET-CT bij pediatrische
    neuroblastoompatiënten
    E.2.2Secondary objectives of the trial
    Comparison of 68Ga-SATO PET/CT imaging to the current clinical
    standard of M123IBG scintigraphy in NBL patients, in terms of lesions
    detection.
    - Comparison of 68Ga-SATO PET/CT imaging to whole body MRI (in case
    available), in terms of lesions detection.
    - To calculate, in a subset of patients, the radiation absorbed dose of
    68Ga-SATO for patients using dynamic PET imaging.
    - Evaluation of procedure time for the preparations and acquisition of a
    68Ga-SATO
    Vergelijking van 68Ga-SATO PET/CT-beeldvorming met de huidige
    klinische standaard van M123IBG-scintigrafie bij NBL-patiënten, in
    termen van detectie van laesies.
    - Vergelijking van 68Ga-SATO PET/CT-beeldvorming met MRI van het
    hele lichaam (indien beschikbaar), in termen van detectie van laesies.
    - Om bij een subgroep van patiënten de door straling geabsorbeerde dosis van 68Ga-SATO voor patiënten te berekenen met behulp van
    dynamische PET-beeldvorming.
    - Evaluatie van de proceduretijd voor de voorbereiding en aanschaf van
    een 68Ga-SATO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 0-18 years
    - Written informed consent (by legal representative) and assent consent
    from the patient when applicable
    - Patients with a clinical suspicion of neuroblastoma who are referred for
    the first time for conventional M123IBG imaging and patients with
    known NBL who are referred for for follow-up M123IBG imaging
    leeftjid tusen de 0-18 jaar (vanaf peuter
    - schriftelijke toestemming (door wettelijke vertegenwoordiger) en
    instemmingstoestemming van de patiënt indien van toepassing
    -patiënten met een klinische verdenking van neuroblastoom die voor het
    eerst worden verwezen voor conventionele M123IBG-beeldvorming en
    patiënten met bekende NBL die worden verwezen voor follow-up
    M123IBG-beeldvorming
    E.4Principal exclusion criteria
    Children with pre-existing severe auto-immune diseases.
    - Use of therapeutic long-acting somatostatin analogs (e.g.
    Sandostatin®, Lanreotide®) within the 21 days before the planned
    infusion of 68Ga-SATO.
    - Use of diuretics within 24 hours before the planned infusion of 68Ga-
    SATO.
    - pregnancy of the patient
    -Kinderen met reeds bestaande ernstige auto-immuunziekten
    -Gebruik van therapeutische langwerkende somatostatine-analogen
    (bijv. Sandostatin®, Lanreotide®) binnen de 21 dagen vóór de geplande
    infusie van 68Ga-SATO
    -Gebruik van diuretica binnen 24 uur vóór de geplande infusie van 68Ga-
    SATO.
    -zwangerschap van de patient
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events according to CTCAE v5.0 encountered after [68GA]-SATOREOTIDE TRIZOXETAN injection.
    Adverse events na toediening van [68GA]-SATOREOTIDE TRIZOXETAN.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 1 hour post acquisition of [68GA]-SATOREOTIDE TRIZOXETAN PET-CT
    Tot en met 1 uur na vervaardigen van [68GA]-SATOREOTIDE TRIZOXETAN PET-CT
    E.5.2Secondary end point(s)
    1. Number and localisation of neuroblastoma lesions detected with [68GA]-SATOREOTIDE TRIZOXETAN PET-CT compared to [123I]mIBG SPECT, segment based according to SIOPEN for skeletal lesions and absolute number of detected soft tissue lesions with [68GA]-SATOREOTIDE TRIZOXETAN PET-CT compared to [123I]mIBG SPECT.
    2. Number and localisation of neuroblastoma lesions detected with [68GA]-SATOREOTIDE TRIZOXETAN PET-CT compared to whole body MRI (if available), absolute number of detected skeletal and soft tissue lesions.
    3. Radiation absorbed dose of 68GA-SATOREOTIDE TRIZOXETAN from patients that underwent dynamic PET imaging.
    1. Aantal en locatie van neuroblastoom laesies zichtbaar op [68GA]-SATOREOTIDE TRIZOXETAN PET-CT in vergelijking met [123I]mIBG SPECT, gebruikmakend van de SIOPEN score voor skeletlaesies en het absolute aantal weke delen laesies.
    2. Aantal en locatie van neuroblastoom laesies zichtbaar op [68GA]-SATOREOTIDE TRIZOXETAN PET-CT in vergelijking met whole body MRI (indien beschikbaar), voor skeletlaesies en het absolute aantal weke delen laesies.
    3. Geabsorbeerde stralingsdosis van 68GA-SATOREOTIDE TRIZOXETAN in patiënten die een dynamische PET scan hebben ondergaan.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Post acquisition of [68GA]-SATOREOTIDE TRIZOXETAN PET-CT
    2. Post acquisition of [68GA]-SATOREOTIDE TRIZOXETAN PET-CT
    3. Post acquisition of [68GA]-SATOREOTIDE TRIZOXETAN PET-CT
    1. Na het verkrijgen van de [68GA]-SATOREOTIDE TRIZOXETAN PET-CT
    2. Na het verkrijgen van de [68GA]-SATOREOTIDE TRIZOXETAN PET-CT
    3. Na het verkrijgen van de [68GA]-SATOREOTIDE TRIZOXETAN PET-CT
    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 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) 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 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 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 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
    Laatste bezoek van laatste proefpersoon
    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 months
    E.8.9.1In the Member State concerned days
    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: 20
    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: 9
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 9
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric neuroblastoma patients (age 0 - 18 years)
    Minderjarige patiënten met neuroblastoom (Leeftijd 0 - 18 jaar)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    Not applicable
    Niet van toepassing
    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 Decision2022-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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