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    Clinical Trial Results:
    The intraoperative use of fluorescent tracers and multimodal imaging techniques in treatment of head and neck cancer

    Summary
    EudraCT number
    		 2013-003578-28
    Trial protocol
    		 DK  
    Global end of trial date
    20 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2018
    First version publication date
    27 May 2018
    Other versions
    Summary report(s)
    		 Study 1
    Study 2 - Study repport

    Trial information

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    Trial identification
    Sponsor protocol code
    2013070001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Department of Clinical Clinical Physiology, Nuclear Medine & PET , Rigshospitalet, 0045 35454216, andreas.kjaer@regionh.dk
    Scientific contact
    Department of Clinical Clinical Physiology, Nuclear Medine & PET , Rigshospitalet, 0045 35454216, andreas.kjaer@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine and implement the intraoperative use of fluorescent tracers and optical imaging in the treatment of oral cancer. Study 1: Near-infrared Fluorescence Tracer Imaging in sentinel Node Biopsi for oral cavity cancer patients Study 2: Near-infrared Fluorescence assisted neck dissection in oral cancer
    Protection of trial subjects
    I accordance with national ethical approval
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    41
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with primary oral cancer referred to Rigshospitalet for surgery as first treatment modality Study 1: Patients planed for SNB-staging surgery Study 2: Patients planed for therapeutic neck dissction

    Pre-assignment
    Screening details
    		 Histology verified squamous cell carcinoma of the oral cavity CT and/or MRI og the neck

    Period 1
    Period 1 title
    over-all trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NIRF-Neck
    Arm description
    		 Study 2: Arm 1: NIR-Fluorescence-guided neck dissection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Indocyanine Green
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Soft tissue use
    Dosage and administration details
    Study 1: 0,05 mg ICG STudy 2: 0,2 mg ICG

    Arm title
    		 Conventional neck dissection
    Arm description
    		 Study 2 Arm 2: Cenventional neck dissection
    Arm type
    		 conventional surgery

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Study 1 - NIRF-SNB
    Arm description
    		 One arm study
    Arm type
    		 Feasibility - no control arm

    Investigational medicinal product name
    Indocyanine Green
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Soft tissue use
    Dosage and administration details
    Study 1: 0,05 mg ICG STudy 2: 0,2 mg ICG

    Number of subjects in period 1
    		NIRF-Neck Conventional neck dissection Study 1 - NIRF-SNB
    Started
    16
    15
    30
    Completed
    16
    15
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    over-all trial
    Reporting group description
    		 -

    Reporting group values
    		 over-all trial Total
    Number of subjects
    		 61 61
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62 ± 3 -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 41 41

    End points

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    End points reporting groups
    Reporting group title
    NIRF-Neck
    Reporting group description
    		 Study 2: Arm 1: NIR-Fluorescence-guided neck dissection

    Reporting group title
    Conventional neck dissection
    Reporting group description
    		 Study 2 Arm 2: Cenventional neck dissection

    Reporting group title
    Study 1 - NIRF-SNB
    Reporting group description
    		 One arm study

    Primary: Study 1: Additional sentinel nodes identified by NIRF-guidance.

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    End point title
    		 Study 1: Additional sentinel nodes identified by NIRF-guidance. [1] [2]
    End point description
    Study 1: Additional sentinel nodes only identified due to the additional use of NIR fluorescence intraoperatively
    End point type
    Primary
    End point timeframe
    post-surgery
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint in study 1 is additional sentinel lymph nodes identified due to use of NIRF imaging - no analysis kan be presented apart from a numerical number.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint in study 1 is additional sentinel lymph nodes identified due to use of NIRF imaging - no analysis kan be presented apart from a numerical number.
    End point values
    		 Study 1 - NIRF-SNB
    Number of subjects analysed
    30
    Units: number of lymph nodes
    11
    No statistical analyses for this end point

    Primary: Study 2: Number of lymph nodes in the neck dissecion specimen from level Ib-III

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    End point title
    		 Study 2: Number of lymph nodes in the neck dissecion specimen from level Ib-III [3] [4]
    End point description
    study 2: Number of lymph nodes harvested in the neck dissecion specimen in level Ib-III
    End point type
    Primary
    End point timeframe
    post-operatively
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint in study 2 is simple the number of harvested lymph nodes in the control Group vs. the NIRF-Neck Group. The stastistics is reported in the attachment report.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint is simple the number of harvested lymph nodes in the control Group vs. the NIRF-Neck Group. The stastistics is reported in the attachment report.
    End point values
    		 NIRF-Neck Conventional neck dissection
    Number of subjects analysed
    16 [5]
    15 [6]
    Units: number of lymph nodes
    406
    317
    Notes
    [5] - 16 patients and 17 neck-sides for analysis
    [6] - 15 patients and 17 neck sides for evaluation
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From time of injection of tracer substance to two weeks post-surgery
    Adverse event reporting additional description
    No adverse events was recorded
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 clinical examination
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events was seen.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26467454
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