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    The EU Clinical Trials Register currently displays   39229   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-003268-19
    Sponsor's Protocol Code Number:BR-TUM-ICG-IV-2
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-003268-19
    A.3Full title of the trial
    Study evaluating breast cancer tumorectomy guided by Near-Infrared imaging after the intravenous injection of free Indocyanine Green
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to see if it is possible to guide tumorectomy in case of breast cancer by near-infrared fluorescence after intravenous injection of Indocyanine Green
    A.4.1Sponsor's protocol code numberBR-TUM-ICG-IV-2
    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 SponsorJules Bordet Institute
    B.1.3.4CountryBelgium
    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 supportJules Bordet Institute
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJules Bordet Institute
    B.5.2Functional name of contact pointProf. Pierre Bourgeois
    B.5.3 Address:
    B.5.3.1Street AddressBd de Waterloo 121
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003225413276
    B.5.6E-mailpierre.bourgeois@bordet.be
    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 Indocyanine Green Pulsion 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPulsion Medical Systems
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 solution 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.3.9.2Current sponsor codeBR-TUM-ICG-IV-2
    D.3.9.3Other descriptive nameINDOCYANINE GREEN
    D.3.9.4EV Substance CodeSUB14208MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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
    Imaging of tumours and their margins after intravenous injection of
    Indocyanine Green to breast cancer patients
    E.1.1.1Medical condition in easily understood language
    imaging of breast cancer with a fluorescent molecule
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Evaluation (on a preliminary series of 20 patients) of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to guide the surgeons during the surgery when they are performing tumorectomy of breast cancer.

    Evaluation of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to show fluorescent “remaining in site” tumoral tissues after such tumorectomy (and how frequently it will happen) and analysis of their histopathological characteristics.
    E.2.2Secondary objectives of the trial
    Comparison to “historical” matched cases of the results of so performed tumorectomies. The following parameters will be analysed:

    - Size of the tumorectomy pieces.
    - Distances between margins and tumoral limits.
    - Positivity of the margins.
    - Delayed interventions for positive margins.

    Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist

    Evaluation of the ability of NIR fluorescence imaging camera device (after the intravenous injection of free ICG) to show fluorescent the sentinel lymph nodes of these patients among the axillary tissues and during their research, resection and (ex vivo and in vivo) analysis of the fluorescence ratios between the SLN and their surrounding fatty tissues
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection.
    - Patients with tumorectomy foreseen after neo-adjuvant therapy will also be enrolled.
    - Informed consent form signed.
    E.4Principal exclusion criteria
    - Diagnosis of mammary cancer established by “gross” biopsy.
    - Age less than18 years old.
    - Inability to give informed consent.
    - History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
    - Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
    - Documented coronary disease.
    - Advanced renal impairment (creatinine > 1,5mg/dl).
    - During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and heparin).
    - Pregnancy, breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation (on a preliminary series of 20 patients) of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to guide the surgeons during the surgery when they are performing tumorectomy of breast cancer.

    Evaluation of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to show fluorescent “remaining in site” tumoral tissues after such tumorectomy (and how frequently it will happen) and analysis of their histopathological characteristics.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery and pathological analysis of the patient
    E.5.2Secondary end point(s)
    Comparison to “historical” matched cases of the results of so performed tumorectomies. The following parameters will be analysed:

    - Size of the tumorectomy pieces.
    - Distances between margins and tumoral limits.
    - Positivity of the margins.
    - Delayed interventions for positive margins.

    Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist

    Evaluation of the ability of NIR fluorescence imaging camera device (after the intravenous injection of free ICG) to show fluorescent the sentinel lymph nodes of these patients among the axillary tissues and during their research, resection and (ex vivo and in vivo) analysis of the fluorescence ratios between the SLN and their surrounding fatty tissues

    Evaluation of one prototype of probe dedicated to the ICG fluorescence detection but also coupled to a gamma probe. This prototype will be evaluated as a complementary way to identify the radioactive sentinel lymph nodes in our patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    After surgery and pathological analysis of the patient
    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 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 Yes
    E.8.1.7.1Other trial design description
    comparison with previous cases without ICG
    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
    After surgery and pathological analysis of the last patient
    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 months2
    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: 54
    F.1.3Elderly (>=65 years) No
    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 state54
    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)
    Best routine care
    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 Decision2014-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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