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    Summary
    EudraCT Number:2019-003828-21
    Sponsor's Protocol Code Number:71617
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-01-21
    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 number2019-003828-21
    A.3Full title of the trial
    Identification of sentinel lymph nodes in breast cancer patients through non-invasively and percutaneously fluorescent imaging using indocyanine green
    Identificatie van de schildwachtklier bij borstkanker patiënten middels niet-invasieve, percutane fluorescente beeldvorming met indocyanine groen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sentinel lymph node procedure in breast cancer patients through fluorescent green imaging
    A.3.2Name or abbreviated title of the trial where available
    INFLUENCE
    A.4.1Sponsor's protocol code number71617
    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 SponsorSt Antonius Hospital
    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 supportSt Antonius Innovatiefonds 2018
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Antonius hospital
    B.5.2Functional name of contact pointPhD Candidate
    B.5.3 Address:
    B.5.3.1Street AddressKoekoekslaan 1
    B.5.3.2Town/ cityNieuwegein
    B.5.3.3Post code3435 CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailc.bargon@antoniusziekenhuis.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 Yes
    D.2.1.1.1Trade name Indocyanine Green (VERDYE)
    D.2.1.1.2Name of the Marketing Authorisation holderDiagnostic Green GmbH
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameINDOCYANINE GROEN
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 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
    Axillar staging in breast cancer patients
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping versus the standard-of-care radioisotope technetium (99mTc) in the SLN procedure for breast cancer patients
    E.2.2Secondary objectives of the trial
    To assess the:
    -sensitivity of the ICG method and the standard 99mTc method to identify the SLN in breast cancer.
    -false negatives of the ICG method and the standard 99mTc method to identify the SLN in breast cancer.
    -false positive rate between ICG method and 99mTc method to identify the SLN in breast cancer
    -number of SLN identified with ICG compared to the standard 99mTc.
    -the difference in pathology of the SLN found by ICG and 99mTc, including the difference between micro- and macro metastasis (Mic and Mac resp.) and isolated tumor cells (ITCs).
    - intraoperative visualization of the SLN with the camera by ICG and 99mTc before skin incision.
    -transit time and detection time for the use of ICG to detect de SLN
    -complications, including wound infection, bleeding and lymphedema, of the combination of the ICG method and the standard 99mTc method to identify the SLN in breast cancer.
    -number of adverse events from the combination of ICG and 99mTc
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinically node-negative, invasive early T1 or T2 breast cancer confirmed by biopsy.
    - Preoperative axillary ultrasound to confirm clinical node-negative status.
    - Indication for lumpectomy and SLN procedure.
    - Written informed consent according to ICH/GCP and national regulations.
    E.4Principal exclusion criteria
    -Patients < 18 years old.
    -Mastectomy.
    -Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc) or intravenous contrast, iodine, shellfish.
    -Other concurrent solid tumor.
    -Hyperthyroidism or thyroid cancer.
    -Palliative surgery for locally advanced breast cancer (cT4).
    -Pregnancy or breast feeding.
    -Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    - Identification rate of SLNs by the fluorescent signal of ICG and by 99mTc.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Peroperatively
    E.5.2Secondary end point(s)
    - Number of lymph nodes identified with ICG and standard 99mTc.
    - Percentage of patients in whom fluorescent SLNs were identified of the total patients with identified SLNs by the standard 99mTc.
    - Percentage of SLNs that is fluorescent, but not positive for 99mTc.
    - Percentage of SLNs that are not fluorescent but positive for 99mTc.
    - Pathology of SLN found by ICG and 99mTc including micro- and macro metastasis and isolated tumor cells (ITCs).
    - Percutaneous intraoperative visualization of the SLN and lymph drainage with the camera by ICG before skin incision: yes, weak, no; only lymph vessel, no both lymph vessel and node are not visible.
    - Detection time: average time between skin incision and SLN resection in minutes.
    - Complication rates from the SN procedure by ICG and 99mTc, including lymph edema, (wound)infection, (temporarily) skin discoloring, bleeding and a mild allergic reaction.
    - Number of serious adverse events from ICG and 99mTc, including severe allergic reaction, death or other serious adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Peroperatively or when pathology report is definitive (i.e., 1 week later) or during follow-up appointment (i.e., 1 week later)
    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 Yes
    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) 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 No
    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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    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 Decision2020-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-09
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