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    Summary
    EudraCT Number:2020-005546-42
    Sponsor's Protocol Code Number:MELISA
    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:2021-07-05
    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 number2020-005546-42
    A.3Full title of the trial
    Sentinel lymph node assessment in ovarian cancer. Lymphatic mapping with two tracers and intraoperative lymphoscintigraphy.
    Evaluación del ganglio centinela en el cáncer de ovario. Estudio del mapa linfático con dos trazadores y gammagrafía intraoperatoria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sentinel lymph node assessment in ovarian cancer. Lymphatic mapping with two tracers and intraoperative lymphoscintigraphy.
    Evaluación del ganglio centinela en el cáncer de ovario. Estudio del mapa linfático con dos trazadores y gammagrafía intraoperatoria.
    A.4.1Sponsor's protocol code numberMELISA
    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 SponsorFundacio Clinic per a la Recerca Biomedica
    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 supportHospital Clinic Barcelona
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clinic
    B.5.2Functional name of contact pointICGON
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34932275400
    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 holderFGK Representative Service GmbH
    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 Powder for injection
    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 INNindocyanine green
    D.3.9.1CAS number 3599-32-4
    D.3.9.3Other descriptive nameINDOCYANINE GREEN
    D.3.9.4EV Substance CodeSUB14208MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 Yes
    D.2.1.1.1Trade name Nanocoloides de albúmina Radiopharmacy
    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 Powder for injection
    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 INNnanocolloidal human albumin
    D.3.9.1CAS number 706786-97-2
    D.3.9.3Other descriptive nameNANOCOLLOIDAL HUMAN ALBUMIN
    D.3.9.4EV Substance CodeSUB190330
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 lymph node in ovarian cancer
    Ganglio centinela en cáncer de ovario
    E.1.1.1Medical condition in easily understood language
    Sentinel lymph node in ovarian cancer
    Ganglio centinela en cáncer de ovario
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Identification of sentinel lymph node in ovarian cancer and assessment of its diagnostic effectiveness in lymphoid mapping using two tracers and intra operative scintigraphy
    Evaluar la detección del ganglio centinela en el cáncer de ovario epitelial inicial así como su rendimiento diagnóstico en la detección de metástasis ganglionares mediante el estudio del mapa linfático con dos trazadores y gammagrafía intraoperatoria
    E.2.2Secondary objectives of the trial
    Lymph mapping in initial stage ovarian cancer patients for each tracer (99mTc-albumin nanocolloid and ICG).
    Usefulness of intra-operative scintygraphy gamma-detecting probe and NIR camera in ovalian lymph mapping.

    - Rate of sentinel node identification with each tracer.
    - False negative rate in metastatic patients.
    - micrometastasis detection rate .
    Valorar el mapa linfático en pacientes con cáncer de ovario epitelial en estadio inicial para cada uno de los dos trazadores (99mTc-nanocoloide de albúmina y ICG).
    - Valorar el rendimiento de la gammagrafía intraoperatoria, la sonda gammadetectora y la cámara de NIR en la visualización del mapa linfático ovárico.

    - Conocer la tasa de identificación del GC, global y específica, según el tipo de trazador utilizado.
    - Evaluar la existencia de falsos negativos en la afectación metastásica del GC.
    - Comprobar si la ultraestadificación del GC mejora la detección de micrometástasis respecto a la histología convencional .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - -Patients with adnexal mass of high suspicion of malignancy requiring intra-operative biopsy.
    -Patients with diagnostic of epithelian ovarian cancer (EOC) in initial stage requiring lymphoid mapping and lymphadenectomy
    - Lack of radiologic retroperitoneal or metastacic disease
    - Pacientes con diagnóstico de masa anexial con alta sospecha de malignidad sometidas a biopsia intraoperatoria (mapa linfático).
    - Pacientes con diagnostico intraoperatorio de COE en estadio inicial (mapa linfático y detección del GC con linfadenectomía sistemática).
    - Ausencia de afectación ganglionar retroperitoneal y enfermedad metastásica a distancia valorado mediante técnicas de imagen.
    E.4Principal exclusion criteria
    Age <18
    - Pregnancy or breastfeeding
    - EOC figo stages III or IV.
    - Biopsy unavailability.
    - Prior vascular surgery, lymphadenectomy or radiotherapy in the region
    - Non-surgical patient.
    - Known allergy to study drugs
    Pacientes <18 años
    - Embarazo o lactancia
    - Tumores epiteliales de ovario estadio figo III o IV.
    - Imposibilidad de obtener biopsia del tumor.
    - Antecedente de cirugía vascular previa (cava, aorta, vasos ilíacos), linfadenectomía (pélvica o paraórtica) o radioterapia (campo pélvico o paraórtico)
    - Paciente no operable.
    - Alergia conocida a los productos en estudio
    E.5 End points
    E.5.1Primary end point(s)
    Existencia de drenaje linfático, definida como la visualización, como mínimo, de un ganglio linfático a nivel pélvico o paraórtico
    Existencia de drenaje linfático, definida como la visualización, como mínimo, de un ganglio linfático a nivel pélvico o paraórtico
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour
    1 hora
    E.5.2Secondary end point(s)
    Time to drainage visualization: minutes since injection until intra-node observation.
    o Assessment of drainage path: pelvic, paraortic, both.
    o Number of sentinel nodes with biopsy
    o Surgical/post-surgical complications
    o duration of admission (days)
    o FIGO stage surgical
    Tiempo de visualización del drenaje: minutos transcurridos desde la inyección hasta la visualización de depósitos activos intraganglionares.
    o Localización del drenaje: pelvis, paraórtica, ambas.
    o Número de ganglios centinela biopsiados
    o Complicaciones intraquirúrgicas y postquirúrgicas
    o Días de ingreso
    o Estadio FIGO quirúrgico
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 días
    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 No
    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 Yes
    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 No
    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
    última visita del último sujeto
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state62
    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 (no procede)
    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 Decision2021-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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