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    Summary
    EudraCT Number:2019-002442-20
    Sponsor's Protocol Code Number:2019/2886
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-12-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-002442-20
    A.3Full title of the trial
    Study evaluating near infrared imaging coupled with indocyanine green for
    preoperative control of resection margins in ENT surgery.
    Etude évaluant l'imagerie proche infrarouge couplée au vert d'indocyanine
    pour le contrôle peropératoire des marges de résection en chirurgie ORL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on near infrared fluorescence imaging with the use of indocyanine
    green to detect microscopic residual disease in real time after surgical
    resection of cancer of the oral cavity, oropharynx, hypopharynx or larynx.
    Etude sur l'imagerie de fluorescence proche infrarouge avec l'utilisation du
    vert d'indocyanine pour détecter en temps réel la maladie résiduelle microscopique après la résection chirurgicale d'un cancer de la cavité orale, de l'oropharynx, de l'hypopharynx ou du larynx.
    A.3.2Name or abbreviated title of the trial where available
    MAGNOLIA
    A.4.1Sponsor's protocol code number2019/2886
    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 SponsorGustave Roussy
    B.1.3.4CountryFrance
    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 supportPHRC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGustave Roussy
    B.5.2Functional name of contact pointSponsor CRA
    B.5.3 Address:
    B.5.3.1Street Address114 rue Edouard Vaillant
    B.5.3.2Town/ cityVillejuif
    B.5.3.3Post code94805
    B.5.3.4CountryFrance
    B.5.4Telephone number0033142116643
    B.5.5Fax number0033142116290
    B.5.6E-mailthibaud.motreff@gustaveroussy.fr
    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 Infracyanine
    D.2.1.1.2Name of the Marketing Authorisation holderSERB
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 and solvent 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.3.9.3Other 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 number2.5
    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
    visualization of the resection margins by near infrared fluorescence imaging (in vivo and ex vivo) for patients over 18 years of age with ENT epidermoid cancer treated by open surgery or by robot-assisted transoral approach
    E.1.1.1Medical condition in easily understood language
    Head and neck cancer
    Cancer de la tête et du cou
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the sensitivity of near-infrared fluorescence imaging in real
    time to detect microscopic residual disease in the surgical specimen
    after complete macroscopic surgical resection of head and neck cancers
    E.2.2Secondary objectives of the trial
    -evaluate the specificity of intraoperative near-infrared fluorescence
    imaging, i.e. its ability to discriminate healthy margins of head and neck cancers.
    -to evaluate the positive predictive value of the intraoperative nearinfrared fluorescence imaging on the operating bed, during a new surgical resection after extemporaneous examination of the suspect zones.
    - Analyze the mapping and kinetics of the tumor-to-background ratio
    (TBR) for head and neck cancers.
    - to evaluate the incidence and grades of significant adverse effects
    due to the injection of ICG (indocyanine green) as a measure of the
    safety and tolerability of the method.
    - to determine the value of near infrared fluorescence imaging combined with ICG for robotic transoral surgery using the Intuitive Firefly module compared to ICG-associated NIRF imaging in the case of open surgery: sensitivity, specificity, mapping and kinetics of the tumor / background ratio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Man or Woman with an age >= 18 years,
    - ECOG performance status 0-2,
    - Histological confirmation of squamous cell carcinoma,
    - Localization of primary tumor in the oral cavity or the oropharynx,
    - Operable disease with intent to be complete resection,
    - Medical or urinary pregnancy test (negative) in the 14 days preceding
    the systemic injection of indocyanine green (preoperative visit), for
    women of childbearing age,
    -Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.,
    - Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
    E.4Principal exclusion criteria
    - Severe medical co-morbidities or contraindications to surgery,
    - Nonoperable primary tumor,
    - History of head and neck cancer in the last 5 years,
    - Radiation history for head and neck cancer,
    - Metastatic cancer,
    - Neoplasms with plaques of necrosis in preoperative imaging,
    - History of invasive cancer except if no recurrence for more than 5 years
    with an exception for non-melanoma skin cancers,
    - Pregnant or lactating woman,
    - Allergy or hypersensitivity to the administered product (its active
    substance or other ingredients), iodized products or crustaceans,
    - Hyperthyroidism, thyroid adenoma, unifocal, multifocal or multinodular
    goitre of autoimmune origin,
    - Documented coronary artery disease,
    - Advanced renal insufficiency (creatinine> 1.5mg / dl),
    - In the 2 weeks prior to inclusion, concomitant medication that reduces
    or increases the extinction of ICG (ie anticonvulsants, haloperidol and
    Heparin),
    - Patient under tutorship or curatorship or deprived of liberty by a
    judicial or administrative decision or patient unable to give consent.
    E.5 End points
    E.5.1Primary end point(s)
    Sensitivity of real-time near-infrared fluorescence imaging in the first
    and last sections in which the pathological examination confirms the
    presence of microscopic residual disease after complete macroscopic
    surgical resection
    E.5.1.1Timepoint(s) of evaluation of this end point
    J1 - Real-time evaluation
    E.5.2Secondary end point(s)
    1) Specificity of real-time near-infrared fluorescence imaging to detect healthy margins in real time,
    2) Positive predictive value of real-time near-infrared fluorescence
    imaging to detect microscopic residual disease in real time in the
    operating bed after excision,
    3) Tumor/background ratio (TBR) mapping and kinetic,
    4) Number of patients with adverse events and their grade to measure safety and tolerability,
    5) Differences between evaluation criteria measured in open surgery and transoral robotic surgery.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 2), 3), and 5) secondary end points : real-time
    4) secondary end point : 30 days +/- 5 days after the surgery
    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 Yes
    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 Yes
    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.8.2.4Number 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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-12-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 65
    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 Decision2020-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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