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    Clinical Trial Results:
    Evaluation of the suitability of PD L 506 for intraoperative visualisation of palpable and nonpalpable breast cancer tissue

    Summary
    EudraCT number
    		 2009-016842-22
    Trial protocol
    		 DE  
    Global end of trial date
    20 Dec 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Sep 2022
    First version publication date
    24 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NCT01110954
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01110954
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    photonamic GmbH & Co. KG
    Sponsor organisation address
    Eggerstedter Weg 12, Pinneberg, Germany, 25421
    Public contact
    Clinical Project Management Department, photonamic GmbH & Co. KG, +49 41017853953, m.stocker@photonamic.de
    Scientific contact
    Clinical Project Management Department, photonamic GmbH & Co. KG, +49 41017853953, m.stocker@photonamic.de
    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
    13 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The study is composed of two consecutive study steps. Only if Step 1 is successfully completed, Step 2 will be performed. Primary Study Aims: •Step 1: Assessment and quantitative determination of PPIX fluorescence in palpable breast cancer tissues after oral administration of PD L 506 for implementation of the technical setting serving as prerequisite for Step 2. •Step 2: Assessment and quantitative determination of PPIX fluorescence in nonpalpable breast cancer tissue after oral administration of one of two different doses of PD L 506.
    Protection of trial subjects
    Application of a sun blocker applied to face, neck and decollete of the patients shortly before surgery in order to avoid phototoxicity during surgery.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2010
    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: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    3
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 8
    Number of subjects completed
    		 7

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Period 1
    Period 1 title
    Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Fluorescence Assessment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    5-Aminolevulinic Acid Hydrochloride
    Investigational medicinal product code
    PD L 506
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    For preparing the oral solution for one patient the powder of two vials had to be dissolved in 100 ml tap water. The calculated volume of the PD L 506 -solution was measured and transferred into an appropriate glass-container.

    Number of subjects in period 1 [1]
    		Fluorescence Assessment
    Started
    7
    Completed
    7
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One patient withdrew her consent the same day she gave it.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study
    Reporting group description
    		 -

    Reporting group values
    		 Study Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.1 ( 5.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 0 0
    Side of Breast Cancer
    Units: Subjects
        Both
    		 1 1
        Left
    		 2 2
        Right
    		 4 4
    Breast Side under Study
    Units: Subjects
        Right
    		 5 5
        Left
    		 2 2
    Palpable/Non-Palpable
    Units: Subjects
        Palpable
    		 6 6
        Non-Palpable
    		 1 1
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 64.3 ( 4.7 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 161.0 ( 4.3 ) -
    Subject analysis sets

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol population consisted of all patients who completed the study according to the protocol.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population includes all patients who received the study medication.

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients who received the study medication according to study protocol.

    Subject analysis sets values
    		 Per Protocol Safety Intention to treat
    Number of subjects
    3
    7
    7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    1
    3
    3
        From 65-84 years
    2
    4
    4
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.7 ( 5.7 )
    67.1 ( 5.1 )
    67.1 ( 5.1 )
    Gender categorical
    Units: Subjects
        Female
    3
    7
    7
        Male
    0
    0
    0
    Side of Breast Cancer
    Units: Subjects
        Both
    1
    1
    1
        Left
    1
    2
    2
        Right
    1
    4
    4
    Breast Side under Study
    Units: Subjects
        Right
    2
    5
    5
        Left
    1
    2
    2
    Palpable/Non-Palpable
    Units: Subjects
        Palpable
    3
    6
    6
        Non-Palpable
    0
    1
    1
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    67.3 ( 5.2 )
    64.3 ( 4.7 )
    64.3 ( 4.7 )
    Height
    Units: cm
        arithmetic mean (standard deviation)
    162.7 ( 3.4 )
    161.0 ( 4.3 )
    161.0 ( 4.3 )

    End points

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    End points reporting groups
    Reporting group title
    Fluorescence Assessment
    Reporting group description
    		 -

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol population consisted of all patients who completed the study according to the protocol.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population includes all patients who received the study medication.

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients who received the study medication according to study protocol.

    Primary: Qualitative assessment of PPIX fluorescence in breast cancer tissues by the investigator

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    End point title
    		 Qualitative assessment of PPIX fluorescence in breast cancer tissues by the investigator [1]
    End point description
    End point type
    Primary
    End point timeframe
    Immediately after excision of the primary tumour
    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: No statistical analyses were planned for this endpoint.
    End point values
    		 Per Protocol Intention to treat
    Number of subjects analysed
    3
    7
    Units: Fluorescence Impression
        none
    3
    4
        weak
    0
    2
        strong
    0
    1
    No statistical analyses for this end point

    Secondary: Severity of Adverse Events

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    End point title
    		 Severity of Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 0 till 7 or 28 days after surgery, respectively.
    End point values
    		 Safety
    Number of subjects analysed
    7
    Units: Number of Adverse Events per category
        Mild
    7
        Moderate
    3
        Severe
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 0 to day 7 or 28, respectively, after study termination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Safety
    Reporting group description
    		 -

    Serious adverse events
    		 Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (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
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 7 (42.86%)
         occurrences all number
    3
    Creatinine urine increased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Blood bilirubin increased
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2010
    Primary tumour resection procedure for both Steps was amended as requested by the Ethics Committee as the clinical study protocol in its final version dated December 28, 2009 did not contain information on how to proceed in case of fluorescence in the tumour cavity after resection of the tumour.
    26 Jul 2012
    Change of Principal Investigator.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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