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    Summary
    EudraCT Number:2019-003825-56
    Sponsor's Protocol Code Number:SENTINELSEEK-HC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-003825-56
    A.3Full title of the trial
    An exploratory prospective, open-label, unicentric study with cross-over design, comparing Lymphoseek® vs. albumin nanocolloid for Image-Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.
    Estudio exploratorio, prospectivo, abierto, unicéntrico, de diseño cruzado para comparar Lymphoseek® con albúmina nanocoloide en la detección de ganglio centinela guiado por imagen en cáncer de cabeza y cuello, cáncer de mama y melanoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An exploratory prospective, open-label, unicentric study with cross-over design, comparing Lymphoseek® vs. albumin nanocolloid for Image-Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.
    Estudio exploratorio, prospectivo, abierto, unicéntrico, de diseño cruzado para comparar Lymphoseek® con albumina nanocolloide en la detección de ganglio centinela guiado por imagen en cáncer de cabeza y cuello, cáncer de mama y melanoma.
    A.3.2Name or abbreviated title of the trial where available
    SENTINELSEEK-HC
    A.4.1Sponsor's protocol code numberSENTINELSEEK-HC
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    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 supportFundació Clínic per a la Recerca Biomèdica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU CLINIC
    B.5.2Functional name of contact pointAnna Cruceta
    B.5.3 Address:
    B.5.3.1Street AddressC. Villarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34932279838
    B.5.5Fax number34932279877
    B.5.6E-mailacruceta@clinic.cat
    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 Lymphoseek
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine B.V.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Radiopharmaceutical precursor
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.3.9.3Other descriptive nameTILMANOCEPT
    D.3.9.4EV Substance CodeSUB119775
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 RoleComparator
    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 NANOCOLL
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Bio-Sciences, S.A.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Radiopharmaceutical precursor
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTECHNETIUM (99MTC) ALBUMIN NANOCOLLOID
    D.3.9.1CAS number 706786-97-2
    D.3.9.3Other descriptive nameTECHNETIUM (99MTC) ALBUMIN NANOCOLLOID
    D.3.9.4EV Substance CodeSUB26658
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 hypothesis is that 99mTc-tilmanocept (Lymphoseek®) can be used safely and will be comparable to nanocolloidal human serum nanocolloidal albumin in Head and Neck, Melanoma and Breast Cancer sentinel lymph node detection and mapping.
    La hipótesis es que 99mTc-tilmanocept (Lymphoseek®) se puede usar de forma segura y será comparable a la albúmina nanocoloidal de suero humano nanocoloidal en la detección y mapeo de ganglios linfáticos centinela de cabeza y cuello, melanoma y cáncer de mama.
    E.1.1.1Medical condition in easily understood language
    Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams
    Comparación de la concordancia de Albumina nanocolloide y Lymphoseek® en la detección de ganglios linfáticos de drenaje primario y escalón secundario mediante la realización de dos linfogammagrafías
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Nodal Concordance defined as the proportion of lymph nodes identified by 99mTc-tilmanocept (Lymphoseek®) compared to the number of lymph nodes identified by nanocolloidal human serum albumin (Nanocolloid®) by performing two separate pre-operative lymphoscintigraphies [Washout period: 2 Day]
    Comparación de la concordancia de Nanocoll® y Lymphoseek® en la detección de ganglios linfáticos de drenaje primario y escalón secundario mediante la realización de dos linfogammagrafías con estudio dinámico estandarizado que incluye imágenes planares precoces y tardías y tomografía SPECT/CT.
    E.2.2Secondary objectives of the trial
     Time frame to ascertain the sentinel nodes
     Concordance among early and delayed images obtained with Lymphoseek®
     Number of sentinel nodes and secondary nodes depicted
     Tracer retention in injection site
     Safety and tolerability of 99mTctilmanocept (Lymphoseek®)
    • Número de ganglios linfáticos por paciente detectados con cada radiotrazador mediante imágenes de SPECT/CT.
    • Tiempo de detección de ganglios centinela y en la distribución de los trazadores entre las imágenes precoces y tardías. (El tiempo de localización del ganglio centinela se evaluará mediante linfogammagrafía por la imposibilidad de evaluar estos tiempos de manera intraoperatoria).
    • Diferencia en el número de ganglios centinela y de segundo escalón detectados por paciente detectados mediante Lymphoseek® y Nanocoll® y las imágenes de SPECT/CT.
    • Frecuencia de aparición de contecimientos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Written informed consent
     Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
     At least 18 years of age at the time of consent.
     The subject is clinically node negative (cN0) at the time of screening.
     In Melanoma Patients
    - Diagnosis of primary melanoma with sentinel node indication ( >0.8 mm Breslow thickness; clinically negative lymph nodes)
     In Breast Cancer Patients
    - T1-T2 N0 breast cancer.
    - Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan.
     In Oral cavity tumors patients
    - T1-T2 N0 oral cavity squamous cell carcinoma
    • Pacientes con diagnóstico de melanoma, de cáncer de mama o de cabeza y cuello confirmado histológicamente y candidato a resección quirúrgica con mapeo de ganglios linfáticos e identificación de ganglio centinela como parte del plan quirúrgico.
    • Edad de 18 años o superior en el momento de otorgar el consentimiento..
    • Sujetos clínicamente con nódulos negativos (cN0) en el momento del screening.
    • Pacientes con melanoma (de línea media, troncal o cabeza y cuello)
    - Diagnóstico de melanoma primario con indicación de ganglio centinela ( grosor >0.8 mm Breslow; nódulos linfáticos clínicamente negativos)
    • Pacientes con cancer de mama (mujeres con IMC > 30 o edad > 65 o que han recibido cirugía o quimioterapia previas)
    - Cáncer de mama T1-T2 N0. Pacientes con carcinoma ductal in situ (DCIS) puro si la biopsia de ganglios linfáticos es parte del plan quirúrgico).
    • Pacientes con tumores de cavidad oral (especialmente suelo de boca o línea media)
    - Carcinoma de células escamosas de cavidad oral T1-T2 N0
    E.4Principal exclusion criteria
     Pregnancy or lactation
     Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
     Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
     Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
     Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).
    • Mujeres embarazadas o en periodo de lactancia
    • Evidencia clínica o radiológica de metástasis ganglionares (incluidos ganglios palpables anormales o aumentados de tamaño)
    • Pacientes que han recibido radioterapia preoperatoria
    • Pacientes sometidos a cirugía o radioterapia de la Cuenca linfática donde drena el tumor primario
    • Pacientes que han sido sometidos a escisión quirúrgica amplia del tumor o reconstrucción compleja (rotación, colgajo libre o injerto de cualquier tipo).
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of the concordance of albumin nanocolloid and Lymphoseek® in lymphatic drainage including the detection of both, primary and secondary lymph nodes, by means of a limphoscintigraphy with standardized dynamic study which includes early and delayed images and an SPECT/CT.
    Evaluación de la concordancia de nanocoloide de albúmina y Lymphoseek® en el drenaje linfático, incluida la detección de ganglios linfáticos primarios y secundarios, mediante una limfogammagrafía con estudio dinámico estandarizado que incluye imágenes tempranas y tardías y una SPECT / CT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30-60 minutes
    30-60 minutos
    E.5.2Secondary end point(s)
    Secondary Efficacy endpoints:

     Per subject concordance of the lymphatic node stations detected with both radiotracers and the SPECT/CT images.
     Per subject concordance of the timeframe to ascertain sentinel nodes. Time to localization of the sentinel node would be assessed by limphoscintigraphy due to the impossibility to asses both times intraoperatively.
     Per subject concordance in the number of sentinel nodes detected and secondary nodes depicted among Lymphoseek® and albumianocolloid and the SPECT/CT images.
     Concordance among early and delayed images obtained with Lymphoseek® and the SPECT/CT

    Other secondary endpoints

     Adverse events [Timeframe 7 days].
    Puntos finales de eficacia secundaria:

     Concordancia por sujeto de las estaciones de ganglios linfáticos detectadas con radiotrazadores y las imágenes SPECT / CT.
     Concordancia por sujeto del plazo para determinar los ganglios centinela. El tiempo hasta la localización del ganglio centinela se evaluaría mediante limfogammagrafía debido a la imposibilidad de evaluar ambas veces durante la operación.
     Concordancia por sujeto en el número de ganglios centinelas detectados y ganglios secundarios representados entre Lymphoseek® y albumianocoloide y las imágenes SPECT / CT.
     Concordancia entre imágenes tempranas y tardías obtenidas con Lymphoseek® y SPECT / CT

    Otros puntos finales secundarios

     Eventos adversos [Marco de tiempo 7 días].
    E.5.2.1Timepoint(s) of evaluation of this end point
    30-60 minutes
    30-60 minutos
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.1.7Other No
    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 trial2
    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
    Última visita del último paciente
    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 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 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: 30
    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 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 state30
    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
    Ninguno
    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 Decision2020-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-20
    P. End of Trial
    P.End of Trial StatusOngoing
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