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    Summary
    EudraCT Number:2019-004914-32
    Sponsor's Protocol Code Number:NL71558.041.19
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2020-03-12
    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 number2019-004914-32
    A.3Full title of the trial
    Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET-CT
    Detectie van schildwachtklieren bij vroeg-stadium mondholtekanker met behulp van Gallium-68-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 oral cancer by means of sentinel lymph node biopsy using Gallium-68-Tilmanocept PET-CT
    Identificatie van lymfekliermetastasen bij patiënten met mondholtekanker middels de schildwachtklierprocedure met behulp van Gallium-68-Tilmanocept PET-CT
    A.3.2Name or abbreviated title of the trial where available
    SEAGATE
    A.4.1Sponsor's protocol code numberNL71558.041.19
    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 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 nameGallium-68-Tilmanocept
    D.3.2Product code V09IA009
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeritumoral 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
    The IMP will be used for the identification of sentinel lymph nodes in patients with early-stage oral squamous cell carcinoma and a clinically negative neck (T1-3N0M0).
    Het IMP zal worden gebruikt voor identificatie van schildwachtklieren bij patiënten met vroeg-stadium mondholte plaveiselcelcarcinomen (T1-3N0M0).
    E.1.1.1Medical condition in easily understood language
    The IMP will be used to identify lymph nodes which are most likely to harbor metastasis in patients with early stage oral cavity cancer.
    Het IMP zal worden gebruikt om lymfeklieren te identificeren die het hoogste risico hebben op het bevatten van eventuele metastasen 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 10073554
    E.1.2Term Sentinel node biopsy
    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 study is to assess the diagnostic accuracy, in terms of sensitivity and negative predictive value, of preoperative 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLN detection. Besides, we aim to compare the diagnostic accuracy of preoperative 68Ga-Tilmanocept PET/CT alone with conventional preoperative lymphoscintigraphy alone.
    E.2.2Secondary objectives of the trial
    • To compare the number of 68Ga-Tilmanocept PET/CT detected SLNs with those detected by means of 99mTc-Tilmanocept lymphoscintigraphy on a per-subject basis.
    • To compare histopathologic assessment (presence or absence of metastasis) of the ex-cised lymph node(s) detected by conventional preoperative 99mTc-Tilmanocept lymphoscin-tigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative 68Ga-Tilmanocept PET/CT.
    • Observing contralateral drainage patterns in lateralized tumors and compare these patterns between of 68Ga-Tilmanocept PET/CT and 99mTc-Tilmanocept lymphoscintigraphy, es-pecially in case of a histopathological positive sentinel node.
    • To assess pairwise inter-observer agreements between 68Ga-Tilmanocept PET/CT and 99mTc-Tilmanocept lymphoscintigraphy regarding preoperative SLN detection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following 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 6: TNM Staging).
    3. Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided fine needle aspiration cytology within 30 days of the SLN procedure.
    4. The patient is a candidate for transoral excision.
    5. Patients with prior malignancy of the head and neck area 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.
    6. The patient is ≥18 years of age at the time of consent.
    7. The patient has an ECOG status of Grade 0 – 2 (see Appendix 7: Performance Status Criteria).
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:

    1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the fol-lowing anatomical areas: non-mobile base of the tongue, oropharynx, nasopharynx, hy-popharynx, and larynx.
    2. The patient is incapacitated.
    3. The patient has had a previous allergic reaction after administration of a radionuclide trac-er.
    4. The patient has had other nuclear imaging studies, conducted within 10 days (240 hours) of injection.
    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 pre-clude reasonable surgical dissection for this trial, or radiotherapy to the neck.
    7. The patient is actively receiving systemic cytotoxic chemotherapy.
    8. The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
    E.5 End points
    E.5.1Primary end point(s)
    The diagnostic accuracy, in terms of sensitivity and negative predictive value, of 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLNB. Furthermore, the diagnostic accuracy, in terms of sensitivity and negative predictive value, for preoperative 68Ga-Tilmanocept PET/CT alone as compared to conventional preoperative lymphoscintigraphy alone.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First a pilot study will be conducted with 10 patients to optimize the imaging protocol and build experience with the outcomes of 68Ga-Tilmanocept PET/CT.
    Following the first 10 included patients, 84 additional patients will be included for the prospective cohort study (n=94), to compare detection rate of SLNs using 68Ga-Tilmanocept PET/CT with the detection rate of SLNs by means of 99mTc-Tilmanocept lymphoscintigraphy, with histopathological examination as the reference standard.
    Finally, in order to reliably assess the accuracy, in terms of sensitivity and negative predictive value, of 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLNB, follow-up data will be collected and analysed for false-negative outcomes.
    E.5.2Secondary end point(s)
    • Preoperative SLN detection rate using 68Ga-Tilmanocept PET/CT as com-pared to conventional lymphoscintigraphy.
    • To compare histopathologic assessment (presence or absence of metastasis) of the excised lymph node(s) detected by conventional preoperative 99mTc-Tilmanocept lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative 68Ga-Tilmanocept PET/CT.
    • Observing contralateral drainage patterns in lateralized tumors and compare these patterns between 68Ga-Tilmanocept PET/CT lymphoscintigraphy and 99mTc-Tilmanocept conventional lymphoscintigraphy, especially in case of a histopathological positive sentinel node.
    • Pairwise inter-observer agreements between by 68Ga-Tilmanocept PET/CT lymphoscintigraphy and 99mTc-Tilmanocept conventional lymphoscintigraphy regarding preoperative SLN detection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    First a pilot study will be conducted with 10 patients to optimize the imaging protocol and build experience with the outcomes of 68Ga-Tilmanocept PET/CT.
    Following the first 10 included patients, 84 additional patients will be included for the prospective cohort study (n=94), to compare detection rate of SLNs using 68Ga-Tilmanocept PET/CT with the detection rate of SLNs by means of 99mTc-Tilmanocept lymphoscintigraphy, with histopathological examination as the reference standard.
    Finally, in order to reliably assess the accuracy, in terms of sensitivity and negative predictive value, of 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLNB, follow-up data will be collected and analysed for false-negative outcomes.

    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 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 Yes
    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
    A within-patient evaluation, patients undergo both diagnostic procedures
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 two-years follow-up of the surgical procedure of the last included patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state94
    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 Decision2020-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-12
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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