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    Clinical Trial Results:
    Diagnostic contribution of XENETIX® CT PERFUSION in pre-therapeutical assessment of hepatocellular carcinoma.

    Summary
    EudraCT number
    		 2011-002609-31
    Trial protocol
    		 DE   AT  
    Global end of trial date
    18 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2017
    First version publication date
    01 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ISO-44-013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01639703
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guerbet
    Sponsor organisation address
    BP57400, Roissy CDG Cedex, France, 95943
    Public contact
    Clinical Project Manager, Guerbet, 33 145915019, camille.pitrou@guerbet-group.com
    Scientific contact
    Clinical Project Manager, Guerbet, 33 145915019, camille.pitrou@guerbet-group.com
    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
    18 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To prospectively determine the diagnostic value of Xenetix®-CT perfusion for the discrimination between well-differentiated HCC and moderately/poorly differentiated HCC (off-site assessment). Histopathology will be used as the gold standard for the evaluation of HCC grading
    Protection of trial subjects
    A patent IV line should be established and maintained throughout the examination. Subjects who might have a particular reaction (e.g., allergic reaction) during the iodine injection should receive added surveillance (e.g., carefully monitored pulse and blood pressure). Examination of the subject will be discontinued if a serious adverse event occurs during or just after injection of Xenetix® (preventing post contrast imaging sequence). In any case, a delay of fourty-eight hours is recommended between two contrast medium examinations (MR or X-Ray). Oxygen equipment, emergency case and antihistaminic medications should be available for immediate treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 85
    Country: Number of subjects enrolled
    Switzerland: 6
    Worldwide total number of subjects
    96
    EEA total number of subjects
    5
    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)
    77
    From 65 to 84 years
    18
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 96
    Number of subjects completed
    		 96

    Period 1
    Period 1 title
    Xenetix CT-perfusion (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Xenetix CT-perfusion
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xenetix
    Investigational medicinal product code
    Other name
    iobitridol
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    For CT-perfusion procedure, 50 mL of Xenetix 350 was administered at a flow rate of 5 mL/sec.

    Number of subjects in period 1
    		Xenetix CT-perfusion
    Started
    96
    Completed
    84
    Not completed
    12
         Consent withdrawn by subject
    5
         Other reason
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Xenetix CT-perfusion
    Reporting group description
    		 -

    Reporting group values
    		 Xenetix CT-perfusion Total
    Number of subjects
    		 96 96
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 77 77
        From 65-84 years
    		 18 18
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.2 ( 11.2 ) -
    Gender categorical
    For one patient, gender was missing.
    Units: Subjects
        Female
    		 22 22
        Male
    		 73 73
        Missing
    		 1 1
    Severity of cirrhosis (Child-Pugh score)
    Units: Subjects
        Class A
    		 79 79
        Class B
    		 8 8
        Class C
    		 2 2
        Missing
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Xenetix CT-perfusion
    Reporting group description
    		 -

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with at least one available histopathology assessment regarding hepatocellular carcinoma WHO classification off-site

    Subject analysis set title
    Patients with well-differentiated lesions
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Among the 38 patients analyzed, 47 lesions were graded as well-differentiated according to the WHO classification.

    Subject analysis set title
    Patients with moderately/poorly-differentiated lesions
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Among the 42 patients analyzed, 43 lesions were graded as moderately/poorly-differentiated according to the WHO classification.

    Primary: Blood Volume (BV) according to degree of lesions differentiation

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    End point title
    		 Blood Volume (BV) according to degree of lesions differentiation
    End point description
    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
    End point type
    Primary
    End point timeframe
    Within a week from CT perfusion to surgery
    End point values
    		 Patients with well-differentiated lesions Patients with moderately/poorly-differentiated lesions
    Number of subjects analysed
    38
    42
    Units: millilitre(s)/100 grams
        arithmetic mean (standard deviation)
    15.93 ( 6.663 )
    13.958 ( 5.315 )
    Statistical analysis title
    		 Difference of means
    Statistical analysis description
    Student t-test, corresponding to superiority of group of well differentiated versus moderately/poorly differentiated. Each of the 3 p-value must be compared to 0.025/3=0.0083
    Comparison groups
    Patients with well-differentiated lesions v Patients with moderately/poorly-differentiated lesions
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0763
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Blood Flow (BF) according to degree of lesions differentiation

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    End point title
    		 Blood Flow (BF) according to degree of lesions differentiation
    End point description
    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
    End point type
    Primary
    End point timeframe
    Within a week from CT perfusion to surgery
    End point values
    		 Patients with well-differentiated lesions Patients with moderately/poorly-differentiated lesions
    Number of subjects analysed
    38
    42
    Units: millilitre(s)/100 grams/min
        arithmetic mean (standard deviation)
    73.042 ( 21.551 )
    72.051 ( 31.792 )
    Statistical analysis title
    		 Difference of means
    Statistical analysis description
    Student t-test, corresponding to superiority of group of well differentiated versus moderately/poorly differentiated. Each of the 3 p-value must be compared to 0.025/3=0.0083
    Comparison groups
    Patients with moderately/poorly-differentiated lesions v Patients with well-differentiated lesions
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4362
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Permeability Surface (PS) according to degree of lesions differentiation

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    End point title
    		 Permeability Surface (PS) according to degree of lesions differentiation
    End point description
    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
    End point type
    Primary
    End point timeframe
    Within a week from CT perfusion to surgery
    End point values
    		 Patients with well-differentiated lesions Patients with moderately/poorly-differentiated lesions
    Number of subjects analysed
    38
    42
    Units: millilitre(s)/100 grams/min
        arithmetic mean (standard deviation)
    26.421 ( 10.014 )
    27.75 ( 9.425 )
    Statistical analysis title
    		 Difference of means
    Statistical analysis description
    Student t-test, corresponding to superiority of group of well differentiated versus moderately/poorly differentiated. Each of the 3 p-value must be compared to 0.025/3=0.0083
    Comparison groups
    Patients with well-differentiated lesions v Patients with moderately/poorly-differentiated lesions
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7261
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Arterial Liver Perfusion (ALP) according to degree of lesions differentiation

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    End point title
    		 Arterial Liver Perfusion (ALP) according to degree of lesions differentiation
    End point description
    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
    End point type
    Secondary
    End point timeframe
    Within a week from CT perfusion to surgery
    End point values
    		 Patients with well-differentiated lesions Patients with moderately/poorly-differentiated lesions
    Number of subjects analysed
    38
    42
    Units: millilitre(s)/min/100 millilitres
        arithmetic mean (standard deviation)
    43.234 ( 16.989 )
    42.967 ( 16.678 )
    No statistical analyses for this end point

    Secondary: Portal Venous Liver Perfusion (PVP) according to degree of lesions differentiation

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    End point title
    		 Portal Venous Liver Perfusion (PVP) according to degree of lesions differentiation
    End point description
    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
    End point type
    Secondary
    End point timeframe
    Within a week from CT perfusion to surgery
    End point values
    		 Patients with well-differentiated lesions Patients with moderately/poorly-differentiated lesions
    Number of subjects analysed
    38
    42
    Units: millilitre(s)/min/100 millilitres
        arithmetic mean (standard deviation)
    19.492 ( 14.586 )
    13.708 ( 13.207 )
    No statistical analyses for this end point

    Secondary: Total Liver Perfusion (TLP) according to degree of lesions differentiation

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    End point title
    		 Total Liver Perfusion (TLP) according to degree of lesions differentiation
    End point description
    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site. TLP = ALP + PVP
    End point type
    Secondary
    End point timeframe
    Within a week from CT perfusion to surgery
    End point values
    		 Patients with well-differentiated lesions Patients with moderately/poorly-differentiated lesions
    Number of subjects analysed
    38
    42
    Units: millilitre(s)/min/100 millitres
        arithmetic mean (standard deviation)
    62.725 ( 15.62 )
    56.674 ( 20.494 )
    No statistical analyses for this end point

    Secondary: Hepatic Perfusion Index (HPI) according to degree of lesions differentiation

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    End point title
    		 Hepatic Perfusion Index (HPI) according to degree of lesions differentiation
    End point description
    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.
    End point type
    Secondary
    End point timeframe
    Within a week from CT perfusion to surgery
    End point values
    		 Patients with well-differentiated lesions Patients with moderately/poorly-differentiated lesions
    Number of subjects analysed
    38
    42
    Units: percentage
        arithmetic mean (standard deviation)
    75.232 ( 18.458 )
    80.834 ( 14.503 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded during and immediately after the CT perfusion examination over a 30 min follow up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Safety Set
    Reporting group description
    		 All included patients receiving at least one injection of Xenetix, regardless of the quantity. This set was used for safety analyses.

    Serious adverse events
    		 Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 84 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 84 (4.76%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 84 (2.38%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 84 (1.19%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 84 (1.19%)
         occurrences all number
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 84 (1.19%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2012
    Modifying the time of surgery, specifying the first non-inclusion criteria, and need of body weight.
    27 Sep 2012
    Modifying inclusion criteria with additional types of surgery, the administration of product and imaging protocol for morphologic CT were clarified, treatment for surgery and anaesthesia’s preparation were excluded from reported concomitant treatment.
    16 Jul 2013
    Adjusting the number of patients to be enrolled, adjusting the acquisition parameters and process for scanning the pathology slides.
    05 Nov 2015
    Modifying the protocol of the central reading of pathology material and the date of study end

    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 reported
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