Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43883   clinical trials with a EudraCT protocol, of which   7296   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-000509-96
    Sponsor's Protocol Code Number:NL71166.041.19
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-000509-96
    A.3Full title of the trial
    Near-infrared fluorescence imaging using indocyanine green as an adjunct to improve standard-of-care sentinel lymph node procedure in pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities: a feasibility trial
    Nabij infrarode fluorescentie visualisatie met behulp van indocyanine groen als toevoeging ter verbetering van de huidige schildwachtklierprocedure voor kinderen met een melanoom of sarcoom van het hoofd/hals/romp, paratesticulair of extremiteiten: een haalbaarheid studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Making use of a fluorescent dye, ICG, to improve sentinel lymph node procedure in pediatric patients
    Het verbeteren van de schildwachtklierprocedure voor pediatrische patienten door middel van de fluorescente stof ICG.
    A.3.2Name or abbreviated title of the trial where available
    ICG to improve sentinel lymph node procedure in pediatric patients
    A.4.1Sponsor's protocol code numberNL71166.041.19
    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.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 pointProfessor, surgeon
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 25
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584CS
    B.5.3.4CountryNetherlands
    B.5.6E-mailm.h.w.wijnen-5@prinsesmaximacentrum.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 Yes
    D.2.1.1.1Trade name VERDYE
    D.2.1.1.2Name of the Marketing Authorisation holderDiagnostic Green GmbH
    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.3.1Product nameIndocyanine green
    D.3.2Product code Indocyanine green
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    Peritumoral 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 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
    Sentinel node procedure for pediatric patients with melanoma or sarcoma
    schildwachtklierprocedure voor pediatrische patienten met een melanoom of sarcoom
    E.1.1.1Medical condition in easily understood language
    Sentinel node procedure for pediatric patients with melanoma or sarcoma
    schildwachtklierprocedure voor pediatrische patienten met een melanoom of sarcoom
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The feasibility of using ICG for intraoperative optical guidance in order to detect the sentinel lymph nodes in paediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities.
    Het bepalen van de haalbaarheid om me ICG de chirurg intraoperatief optisch te geleiden naar de schildwachtklier bij pediatrische patienten met een melanoom of sarcoom ter plaatse van het hoofd/hals/romp, paratesticulair of extremiteiten.
    E.2.2Secondary objectives of the trial
    1. Surgical evaluation of fluorescent imaging, which will be measured by means of a short questionnaire tailored for the surgeon;
    2. Correlation between near-infrared (NIR) fluorescent and radioactive sentinel lymph nodes (SLNs);
    3. Number of failures to find the preoperatively detected SLNs;
    4. Tumor to background ratio (tumor fluorescence divided by background fluorescence) of the SLNs;
    5. The safety of using a pre-operative injection of ICG for the SLN procedure in paediatric patients.
    1. Chirurgische evaluatie van fluorescentie imaging, welke gemeten wordt met een korte vragenlijst voor de chirurg
    2. Correlatie tussen NIR fluorescentie en radioactieve schildwachtklieren.
    3. Aantal keren waarin het detecteren van preoperatief geidentificeerde schildwachtklieren niet succesvol was.
    4. Ratio van tumor ten opzichte van de achtergrond; in dit geval schildwachtklier/achtergrond.
    5. De veiligheid van het gebruik van een pre-opeartieve injectie ICG voor de schildwachtklierprocedure bij pediatrische patienten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities that have an indication for a sentinel node procedure.
    Age 0-18 years.
    Written informed consent from patient/parents/legal guardians, according to local law and regulations.
    Pediatrische patienten met een melanoom of sarcoom van hoofd/hals/romp, paratesticulair of extremiteiten met een indicatie om een schildwachtklierprocedure te ondergaan.
    Leeftijd 0-18 jaar.
    Getekend toestemmingsformulier van ouders/patient/wettelijk vertegenwoordiger.
    E.4Principal exclusion criteria
    1. Allergy to iodine
    2 Hypersensitivity to ICG
    3. Kidney insufficiency (eGFR<55)
    4. Clinical manifest hyperthyroidism/ autonomous thyroid adenoma
    5. Nanocolloid or shell fish allergy (same as in standard care: or Technetium-nanocolloid use)
    1. Jodium allergie
    2. Overgevoeligheid voor ICG
    3. Nierfunctiestoornissen (eGFR<55)
    4. Klinisch manifeste hyperthyreoïdie/ autonoom schildklieradenoom)
    5. Nanocolloid of schelpdieren allergie (gelijkend aan reguliere zorg ivm gebruik Technetium-nanocolloid)
    E.5 End points
    E.5.1Primary end point(s)
    The intraoperative detection of SLNs in paediatric patients who received a pre-operative injection of ICG (in addition to 99mTc-nanocolloid) without blue dye.
    De intra-operatieve detectie van de schildwachtklier in pediatrische patienten die een pre-operatieve injectie ICG (in additie op Technetium-nanocolloid) hebben gekregen, zonder blauwe kleurstof.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Intraoperative (fluorescent SLNs) and postoperative (pathological confirmation of SLNs)
    Intraoperatief (fluorescente schildwachtklieren) en postoperatief (pathologische confirmatie van de schildwachtklieren)
    E.5.2Secondary end point(s)
    1. Surgical evaluation of fluorescent imaging, which will be measured by means of a short questionnaire tailored for the surgeon;
    2. Correlation between near-infrared (NIR) fluorescent and radioactive sentinel lymph nodes (SLNs);
    3. Number of failures to find the preoperatively detected SLNs;
    4. Tumor to background ratio (tumor fluorescence divided by background fluorescence) of the SLNs;
    5. The safety of using a pre-operative injection of ICG for the SLN procedure in paediatric patients.
    1. Chirurgische evaluatie van fluorescentie imaging, welke gemeten wordt met een korte vragenlijst voor de chirurg
    2. Correlatie tussen NIR fluorescentie en radioactieve schildwachtklieren.
    3. Aantal keren waarin het detecteren van preoperatief geidentificeerde schildwachtklieren niet succesvol was.
    4. Ratio van tumor ten opzichte van de achtergrond; in dit geval schildwachtklier/achtergrond.
    5. De veiligheid van het gebruik van een pre-opeartieve injectie ICG voor de schildwachtklierprocedure bij pediatrische patienten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Postoperatieve evaluation surgeon
    2. Intra-operative measurements, post-operative analysis
    3. Post-operative calculations
    4. Post-operative post-processing of data
    5. Up to 72 hours post injection ICG
    1. Post-operatieve evaluatie van betreffende chirurg
    2. Intra-operatieve metingen en post-operatieve analyse
    3. Post-operatieve berekening
    4. Post-operatieve verwerking van de data
    5. Tot 72 uur na toediening ICG.
    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) 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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 years
    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: 22
    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: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 melanoma or sarcoma patients (0-18 years)
    Pediatrische melanoom of sarcoom patienten (0-18 jaar)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    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
    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 Decision2020-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-11-03
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 21 02:35:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA