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    The EU Clinical Trials Register currently displays   44298   clinical trials with a EudraCT protocol, of which   7352   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).

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    Summary
    EudraCT Number:2021-002470-42
    Sponsor's Protocol Code Number:72010
    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:2021-10-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-002470-42
    A.3Full title of the trial
    Sentinel lymph node detection in thyroid carcinoma using [68Ga]Ga-tilmanocept PET/CT: A proof of concept study
    Detectie van schildwachtklieren bij schildklier carcinoom met behulp van [68Ga]Ga-tilmanocept PET/CT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Identification of lymphatic metastasis in patients with thyroid cancer by means of sentinel lymph node biopsy using [68Ga]Ga-tilmanocept PET/CT
    Identificatie van lymfeklier uitzaaitingen bij patienten met schildklierkanker middels schildwachtklierprocedure met behulp van [68Ga]Ga-tilmanocept PET/CT
    A.4.1Sponsor's protocol code number72010
    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 SponsorUniveristy Medical Center Utrecht
    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 supportUniveristy Medical Center Utrecht
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniveristy Medical Center Utrecht
    B.5.2Functional name of contact pointClinical trial office
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.6E-mailtrialbureaucancercenter@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 name[68Ga]Ga-Tilmanocept
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeritumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTilmanocept
    D.3.9.1CAS number 1262984-82-6
    D.3.9.4EV Substance CodeSUB119775
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN68-Gallium
    D.3.9.3Other descriptive nameGALLIUM (68GA)
    D.3.9.4EV Substance CodeSUB194211
    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.IMP: 2
    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.2.1.1.1Trade name [99mTc]Tc-ICG-Nanocolloid
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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[99mTc]Tc-ICG-Nanocolloid
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeritumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN99mTC-Nanocolloid
    D.3.9.3Other descriptive nameTECHNETIUM NANOCOLLOID (99MTC)
    D.3.9.4EV Substance CodeSUB121900
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNICG
    D.3.9.1CAS number 3599-32-4
    D.3.9.3Other descriptive nameINDOCYANINE GREEN
    D.3.9.4EV Substance CodeSUB14208MIG
    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
    The IMP will be used for the identification of sentinel lymph nodes in patients with thyroid carcinoma
    Het IMP zal worden gebruikt voor de identificatie van schildwachtklieren bij patiënten met schildkliercarcinoom
    E.1.1.1Medical condition in easily understood language
    The IMP will be used to identify lymph nodes which are most likely to contain metastasis in patients with thyroid carcinoma
    Het IMP zal worden gebruikt om de lymfeklieren te identificeren die de grootste kans op hebben om metastasen te bevatten bij patiënten met schildkliercarcinoom
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10066474
    E.1.2Term Thyroid cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10072873
    E.1.2Term Sentinel lymph node mapping
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10073554
    E.1.2Term Sentinel node biopsy
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to prove the concept of sentinel lymph node imaging in thyroid carcinoma using preoperative 68Ga-tilmanocept PET/CT combined with intraoperative gamma probe and fluorescence camera localization. The number of visualized and resected SLNs will be assessed.
    Het primaire doel van deze studie is het concept van schildwachtklier identificatie bij schildkliercarcinoom te bewijzen met behulp van preoperatieve 68Ga-tilmanocept PET/CT gecombineerd met peroperatieve gamma probe en fluorescentie camera. Het aantal gevisualiseerde en gereseceerde schildwachtklieren zal worden geëvalueerd.
    E.2.2Secondary objectives of the trial
    To
    • Assess the localization of the sentinel lymph nodes
    • Compare the pathological results of the sentinel lymp nodeswith the results of the rest of the lymph node level
    • Define the optimal scan protocol
    • Assess the (additional) surgical time
    • Quantify how the surgeon experiences the complexity, feasibility and additional value of the various methods to identify the sentinel lymph nodesusing a questionnaire
    Om
    - De lokalisatie van de schildwachtklieren te bepalen
    - De pathologie uitslag van de schildwachtklieren te vergelijken met de resultaten van de rest van het lymfeklierniveau
    - Het optimale scan protocol te bepalen
    - De (extra) operatietijd vast te stellen
    - Kwantificeren hoe de chirurg de complexiteit, haalbaarheid en toegevoegde waarde van de verschillende methoden om de schildwachtklieren te identificeren ervaart aan de hand van een vragenlijst
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All of the following criteria:
    • The patient has provided written informed consent authorization before participating in the study
    • Cytologic diagnosis of differentiated thyroid carcinoma (Bethesda 6) and will undergo a hemi- or total thyroidectomy, or cytologic diagnosis of medullary thyroid carcinoma(Bethesda 6)
    • The patient is ≥18 years of age at time of consent
    • The patient has an ECOG status of Grade 0 – 2
    Alle volgende criteria:
    - De patiënt heeft schriftelijke informed consent gegeven voor deelname aan de studie
    - Cytologische diagnose van gedifferentieerd schildkliercarcinoom(Bethesda 6) en zal een hemi- of totale thyreoïdectomie ondergaan, of cytologische diagnose van medullair schildkliercarcinomo (Bethesda 6)
    - De patiënt is ≥18 jaar oud op het moment van toestemming
    - De patiënt heeft ECOG-status graad 0 - 2
    E.4Principal exclusion criteria
    Any of the following criteria:
    • The patient is incapacitated
    • The patient is pregnant or lactating
    • The patient has a history of neck dissection, gross injury or radiotherapy to the neck that would preclude reasonable surgical dissection for this trial
    • The patient will undergo minimally invasive thyroid surgery (via the axilla or trans-oral approach)
    • The patient is actively receiving systemic cytotoxic chemotherapy.
    • The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy
    • The patient has a preoperatively histologically proven multifocal tumor
    Een van de volgende criteria:
    - De patiënt is onbekwaam
    - De patiënt is zwanger of geeft borstvoeding
    - De patiënt heeft een voorgeschiedenis van halsklierdissectie, ernstig letsel of radiotherapie van de hals die een chirurgische dissectie voor deze studie zou uitsluiten
    - De patiënt ondergaat minimaal invasieve schildklierchirurgie (via transaxillaire of transorale benadering)
    - De patiënt krijgt systemische cytotoxische chemotherapie
    - De patiënt ondergaat een immunosuppressiva, anti-monocyten of immunomodulerende therapie
    - De patiënt heeft een preoperatief histologisch bewezen multifocale tumor
    E.5 End points
    E.5.1Primary end point(s)
    • Number of sentinel lymph nodes determined on PET/CT
    • Number of resected sentinel lymph nodes
    - Aantal schildwachtklieren bepaald op PET/CT
    - Aantal gereseceerde schildwachtklieren
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 2 days
    Binnen 2 dagen
    E.5.2Secondary end point(s)
    • Localization of sentinel lymph nodes
    • Pathology result of sentinel lymph nodes compared to pathology result of rest of lymph node level
    • Optimal scan protocol
    • (Additional) surgical time
    • Questionnaire directed to the surgeon about complexity, feasibility and additional value of various identification methods for sentinel lymph nodes
    - Lokalisatie van schildwachtklieren
    - Pathologie uitslag van schildwachtklieren in vergelijking met pathologe uitslag van rest van lymfeklierlevel
    - Optimaal scanprotocol
    - (Extra) operatietijd
    - Vragenlijst gericht aan de chirurg over complexiteit, haalbaarheid en toegevoegde waarde van verschillende identificatiemethoden voor schildwachtklieren

    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 1-10 days
    Ongeveer 1-10 dagen
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Eenarmige studie
    Single arm trial
    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 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
    After all endpoints are known of all participants, so approximately 10 days after the last inclusion.
    Nadat alle eindpunten bij alle deelnemers bepaald zijn, dus ongeveer 10 dagen na de laatste inclusie.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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
    Geen
    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 Decision2021-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    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.

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