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    Summary
    EudraCT Number:2021-003554-23
    Sponsor's Protocol Code Number:NL68976.041.19
    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:2021-10-27
    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 number2021-003554-23
    A.3Full title of the trial
    Sentinel lymph node detection in early-stage ORal Cavity squamous cell
    carcinoma using Magnetic Resonance (MR) lymphogrAphy
    Detectie van schildwachtklieren bij vroeg-stadium mondholtekanker met
    behulp van MR lymfografie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Identification of lymphatic metastasis in patients with oral cavity
    squamous cell carcinoma by means of MR lymphography
    Identificatie van lymfekliermetastasen bij patiënten met mondholtekanker
    middels MR lymfografie
    A.3.2Name or abbreviated title of the trial where available
    ORCA
    ORCA
    A.4.1Sponsor's protocol code numberNL68976.041.19
    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 SponsorUniversity 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 supportUniversity Medical Center Utrecht
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity 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 code3584CX
    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 nameGadovist
    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 INNGadovist
    D.3.9.1CAS number 138071-82-6
    D.3.9.3Other descriptive nameGADOBUTROL
    D.3.9.4EV Substance CodeSUB07861MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1.0
    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 Yes
    D.3.11.13.1Other medicinal product typeMRI contrast agent
    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 node(s) in patients with early-stage oral cavity squamous cell carcinoma and a clinically negative neck (T1-3, N0, M0).
    Het IMP zal worden gebruikt voor de identificatie van schildwachtklier(en) bij patiënten met vroeg-stadium mondholte plaveiselcelcarcinomen met een klinisch negatieve hals (T1-3, N0, M0).
    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 early-stage oral cavity cancer.
    Het IMP zal worden gebruikt om de lymfeklieren te identificeren die de grootste kans hebben om metastasen te bevatten bij patiënten met vroeg-stadium mondholtekanker.
    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 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 10004822
    E.1.2Term Biopsy of lymph node
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10030961
    E.1.2Term Oral cancer stage unspecified
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this pilot study is to investigate the detection rate of SLNs using MR lymphography.
    Het primaire doel van deze pilot studie is om de uitvoerbaarheid en betrouwbaarheid van MR lymfografie in het Universitair Medisch Centrum Utrecht, voor de detectie van schildwachtklieren in patiënten met vroeg-stadium mondholtecarcinomen, te onderzoeken.
    E.2.2Secondary objectives of the trial
    • To compare the number of MR lymphography detected SLNs with those detected by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis.
    • To compare pathologic assessment (presence or absence of isolated tumor cells and (micro-)metastasis) of the excised lymph node(s)SLN(s) identified by 99mTc-nanocolloid lymphoscintigraphy and MR lymphography on a per-subject basis.
    • Observing contralateral drainage patterns in lateralized tumours and compare these patterns between MR lymphography and 99mTc nanocolloid lymphoscintigraphy, especially in case of a positive sentinel node.
    • To assess pairwise interobserver agreements between MR lymphography and 99mTc-nanocolloid lymphoscintigraphy regarding preoperative SLN detection.
    - Het aantal met MR-lymfografie gedetecteerde SLN's vergelijken met het aantal met 99mTc-nanocolloïd lymfoscintigrafie gedetecteerde SLN's, per proefpersoon.
    - Vergelijking van de pathologische beoordeling (aan- of afwezigheid van geïsoleerde tumorcellen en (micro-)metastasen) van de geëxcideerde lymfeklier(en) die met 99mTc-nanocolloïd lymfoscintigrafie en MRlymfografie zijn geïdentificeerd, per proefpersoon.
    - Contralaterale drainagepatronen bij gelateraliseerde tumoren waarnemen en deze patronen vergelijken tussen MR-lymfografie en 99mTc-nanocolloïd lymfoscintigrafie, in het bijzonder in geval van een positieve schildwachtklier.
    - De interobserver-overeenkomsten tussen MR-lymfografie en 99mTc-nanocolloïd
    lymfoscintigrafie met betrekking tot preoperatieve SLN detectie te beoordelen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has provided written informed consent authorization before participating in the study.
    2. The patient has a diagnosis of primary oral squamous cell carcinoma that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingival (retromolar trigone), floor-of-the-mouth, hard palate or oral (mobile) tongue, and is stage T1-T2 and T3 (only when T3 is assessed based on tumor
    dimensions of >2 cm and ≤4 cm with DOI >10 mm), N0, M0 (see Appendix 3: TNM Staging).
    3. Clinical nodal staging (N0) has been confirmed by negative results from CT, MRI, PET/CT and/or ultrasound guided fine needle aspiration cytology within 30 days of the SLNB procedure.
    4. The patient is a candidate for transoral excision and sentinel lymph node biopsy.
    5. The patient has given informed consent for a surgical procedure regarding his/her oncological treatment.
    6. Patients with prior malignancy are allowed, provided the patient meets both of the following criteria:
    • Underwent potentially curative therapy for all prior head and neck malignancies and is deemed low risk for recurrence; and
    • No head and neck malignancy for the past five years and no evidence of recurrence.
    7. The patient is ≥18 years of age at the time of consent.
    8. The patient has an ECOG status of Grade 0 – 2 (see Appendix 4: Performance Status Criteria).
    1. De patiënt heeft schriftelijke toestemming verstrekt ('informed consent') voordat hij aan het onderzoek deelneemt.
    2. De patiënt heeft een diagnose van een primair plaveiselcelcarcinoom van de mondholte, die anatomisch gelokaliseerd is in: mucosale gedeelte van de lip, buccale mucosa, onderste- en bovenste alveolaire kam, retromalaire gingiva (trigonum retromolare), mondbodem, palatum durum of mobiele gedeelte van de tong (oral tong), op basis van TNM-stadiering is T1-T2 en T3 (alleen indien T3 is vastgesteld op basis van
    tumordimensies van > 2 cm en ≤ 4 cm met een invasiediepte van > 10 mm), N0, M0.
    3. De klinische negatieve cervicale lymfeklierstatus (cN0) is bevestigd middels CT-scan, MRI-scan, PET/CT-scan en/of echogeleide cytologische punctie binnen 30 dagen voorafgaand aan de schildwachtklier procedure.
    4. De patiënt is kandidaat voor transorale tumorexcisie en schildwachtklier procedure.
    5. De patiënt heeft toestemming gegeven voor een operatie als onderdeel van de behandeling.
    6. De patiënt met een eerdere maligniteit in de voorgeschiedenis zijn toegestaan, op voorwaarde dat de patiënt aan beide van de volgende criteria voldoet:
    * Patiënt onderging potentieel curatieve therapie voor alle eerdere maligniteiten, waarbij het risico op een recidief als laag wordt beschouwd; en
    * Patiënt heeft geen maligniteit gehad in het hoofd-halsgebied in de afgelopen vijf jaar waarbij er geen aanwijzingen zijn voor een recidief.
    7. De patiënt is 18 jaar of ouder op het moment van toestemming voor deelname.
    8. De patiënt heeft de ECOG-status van graad 0 - 2.
    E.4Principal exclusion criteria
    1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oropharynx, nasopharynx, hypopharynx, and larynx.
    2. The patient is pregnant or lactating.
    3. Patient is incapacitated.
    4. Previous allergic reaction after administration of a gadolinium-based contrast agent for contrast enhanced MR imaging.
    5. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
    6. The patient has a history of neck dissection, or gross injury to the neck that would preclude reasonable surgical dissection for this trial, or radiotherapy to the neck.
    7. The patient is actively receiving systemic cytotoxic chemotherapy.
    8. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
    9. Patient has severe renal impairment (eGFR<30).
    10. Participation will result in unacceptable delay regarding oncological treatment.
    11. Patients with known claustrophobia, who are as a consequence unable to undergo MR imaging.
    1. De patiënt heet een diagnose van plaveiselcelcarcinoom in het hoofdhalsgebied in één van de volgende anatomische gebieden: niet-mobiele gedeelte van de tong (tongbasis), orofarynx, nasofarynx, hypofarynx en larynx.
    2. De patiënt is zwanger of geeft borstvoeding ten tijde van het onderzoek.
    3. De patiënt is wilsonbekwaam.
    4. De patiënt heeft een eerdere allergische reactie gehad na toediening van een op gadolinium gebaseerd contrastmiddel in het kader van een MRI-scan met contrast.
    5. Bij patiënt is er klinisch of radiologisch bewijs voor regionale lymfekliermetastasen.
    6. De patiënt in het verleden een halsklierdissectie heeft doorgemaakt of letsel van de hals heeft doorgemaakt die chirurgische dissectie of radiotherapie van de hals zou uitsluiten.
    7. De patiënt krijgt systemische cytotoxische chemotherapie.
    8. De patiënt krijgt immunosuppresieve, anti-monocyten- of immuunmodulatoire therapie.
    9. De patiënt heeft ernstige nierinsuffiiciëntie (eGFR <30).
    10. Deelname leidt niet tot onaanvaardbare vertraging van de oncologische behandeling.
    11. Patiënten die claustrofobisch zijn en hierdoor geen MRI scans kunnen ondergaan.
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome measure is the detection rate of sentinel lymph nodes with MR lymphography, compared to conventional lymphoscintigraphy with 99mTc nanocolloid and histopathological examination as the reference standard.
    De belangrijkste uitkomstmaat is de detectiegraad van schildwachtklieren met MR lymfografie, in vergelijking met conventionele lymfoscintigrafie met 99mTc-nanocolloïd en
    histopathologisch onderzoek als de referentiestandaard.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First a pilot study will be conducted with 10 patients to build experience with the outcomes of MR lymphography in patients with early-stage oral cavity squamous cell carcinoma.
    Eerst zal er een pilot studie worden uitgevoerd met 10 patiënten om ervaring op te doen met de resultaten van 68-galium-tilmanocept PET/CT bij patiënten met vroeg-stadium mondholtekanker.
    E.5.2Secondary end point(s)
    • To compare the number of MR lymphographic detected SLNs with those detected by means of 99mTc-nanocolloid lymphoscintigraphy on a per-subject basis.
    • To compare histopathologic assessment (presence or absence of metastasis) of the excised lymph node(s) detected by conventional preoperative 99mTc-nanocolloid lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative MR lymphography.
    • Observing contralateral drainage patterns in lateralized tumors and compare these patterns between MR lymphography and conventional 99mTc-nanocolloid lymphoscintigraphy.
    • To assess pairwise inter-observer agreements between MR lymphography and conventional 99mTc-nanocolloid lymphoscintigraphy regarding preoperative SLN detection.
    - Het aantal MR lymfografische gedetecteerde schildwachtklieren te vergelijken met die gedetecteerd met behulp van conventionele lymfoscintigrafie op individuele basis.
    - Histopathologische uitslag (aan- of afwezigheid van geïsoleerde tumorcellen en (micro-)metastasen) van de geëxcideerde schildwachtklier(en) gedetecteerd door conventionele preoperatieve lymfoscintigrafie en intraoperatieve gammaprobe detectie te vergelijken met de schildwachtklieren geïdentificeerd door middel van preoperatieve
    MR lymfografie.
    - Observatie van contralaterale drainagepatronen bij gelateraliseerde mondholtetumoren en het vergelijken van deze patronen tussen MR lymfografie en conventionele lymfoscintigrafie.
    - Om de interobserver variabiliteit tussen MR lymofgrafieen conventionele lymfoscintigrafie, met betrekking tot preoperatieve detectie van schildwachtklieren, te onderzoeken.
    E.5.2.1Timepoint(s) of evaluation of this end point
    First a pilot study will be conducted with 10 patients to build experience with the outcomes of MR lymphography in patients with early-stage oral cavity squamous cell carcinoma.
    Eerst zal er een pilot studie worden uitgevoerd met 10 patiënten om ervaring op te doen met de resultaten van MR lymfografie bij patiënten met vroeg-stadium mondholte kanker.
    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) 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 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.8.3 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 Yes
    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 years1
    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 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 No
    F.3.3.7Others No
    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
    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 Decision2021-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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