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    Clinical Trial Results:
    A Study of BR55 in Contrast Enhanced Ultrasound Imaging in Patients with Ovarian and Breast Cancer.

    Summary
    EudraCT number
    		 2012-000699-40
    Trial protocol
    		 IT  
    Global end of trial date
    02 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2021
    First version publication date
    27 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BR55-102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bracco Diagnostics, Inc.
    Sponsor organisation address
    259 Prospect Plains Rd, , Cranbury, United States, 08512
    Public contact
    Global Medical & Regulatory Affairs, Bracco Imaging spa, 609 514-2200,
    Scientific contact
    Global Medical & Regulatory Affairs, Bracco Imaging spa, 609 514-2200,
    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
    16 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess ultrasound imaging results with BR55 in the detection of cancer lesions in patients with ovarian cancer or ovarian mass or patient with breast cancer using histology as the truth standard for the presence/absence of malignant lesions.
    Protection of trial subjects
    The safety endpoints for patients enrolled in the preceding (at least 4 patients) dose group were to be completed and reviewed for any unexpected safety risks before proceeding with the enrollment in the next dose group.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Oct 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
    Italy: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    38
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient enrolled: 25 October 2012 Last patient completed: 2 April 2014

    Pre-assignment
    Screening details
    		 Two enrolled patients did not receive drug, one had suspected cardiac ischemia indicated at the predose ECG examination, and one had uncontrolled systemic hypertension at the predose clinical evaluation.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ovary Patients
    Arm description
    		 Ovary Patients scheduled to undergo surgery for primary ovarian cancer or ovarian mass
    Arm type
    		 Experimental

    Investigational medicinal product name
    BR55
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Each patient in the 3 dose groups (Group A = 0.03 mL/kg, Group B = 0.05 mL/kg, and Group C = 0.08 mL/kg) received one injection of BR55 at the assigned dose. The maximum dose of BRU2248 for a patient cannot exceed 100 µg and therefore body weight could not be greater than 95 kg in this study. The calculated dose of BR55 was determined by body weight using a dosing calculation guide. BR55 was administered as a slow intravenous bolus injection through an angiocatheter (20G). Each injection was followed immediately by a 10 mL 0.9% NaCl flush.

    Arm title
    		 Breast Patients
    Arm description
    		 Breast Patients scheduled to undergo primary breast cancer surgery or large core biopsy of the breast
    Arm type
    		 Experimental

    Investigational medicinal product name
    BR55
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Each patient in the 3 dose groups (Group A = 0.03 mL/kg, Group B = 0.05 mL/kg, and Group C = 0.08 mL/kg) received one injection of BR55 at the assigned dose. The maximum dose of BRU2248 for a patient cannot exceed 100 µg and therefore body weight could not be greater than 95 kg in this study. The calculated dose of BR55 was determined by body weight using a dosing calculation guide. BR55 was administered as a slow intravenous bolus injection through an angiocatheter (20G). Each injection was followed immediately by a 10 mL 0.9% NaCl flush.

    Number of subjects in period 1 [1]
    		Ovary Patients Breast Patients
    Started
    24
    21
    Completed
    24
    21
    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: Two enrolled patients did not receive drug, one had suspected cardiac ischemia indicated at the predose ECG examination, and one had uncontrolled systemic hypertension at the predose clinical evaluation.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 45 45
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 38 38
        ≥65 years
    		 7 7
    Gender categorical
    Units: Subjects
        Female
    		 45 45
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Ovarian Patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Ovary Patients scheduled to undergo surgery for primary ovarian cancer or ovarian mass

    Subject analysis set title
    Breast Patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Breast Patients scheduled to undergo primary breast cancer surgery or large core biopsy of the breast

    Subject analysis set title
    Patients with Malignant Ovarian Lesions
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with Malignant Ovarian Lesions

    Subject analysis set title
    Patients with Benign Ovarian Lesions
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with Benign Ovarian Lesionsc

    Subject analysis set title
    Patients with Malignant Breast Lesions
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with Malignant Breast Lesionsb

    Subject analysis set title
    Patients with Benign Breast Lesions
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with Benign Breast Lesionsb

    Subject analysis sets values
    		 Ovarian Patients Breast Patients Patients with Malignant Ovarian Lesions Patients with Benign Ovarian Lesions Patients with Malignant Breast Lesions Patients with Benign Breast Lesions
    Number of subjects
    24
    21
    13
    11
    17
    4
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    18
    20
    10
    8
    16
    4
        ≥65 years
    6
    1
    3
    3
    1
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    24
    21
    13
    11
    17
    4
        Male
    0
    0
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Ovary Patients
    Reporting group description
    		 Ovary Patients scheduled to undergo surgery for primary ovarian cancer or ovarian mass

    Reporting group title
    Breast Patients
    Reporting group description
    		 Breast Patients scheduled to undergo primary breast cancer surgery or large core biopsy of the breast

    Subject analysis set title
    Ovarian Patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Ovary Patients scheduled to undergo surgery for primary ovarian cancer or ovarian mass

    Subject analysis set title
    Breast Patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Breast Patients scheduled to undergo primary breast cancer surgery or large core biopsy of the breast

    Subject analysis set title
    Patients with Malignant Ovarian Lesions
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with Malignant Ovarian Lesions

    Subject analysis set title
    Patients with Benign Ovarian Lesions
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with Benign Ovarian Lesionsc

    Subject analysis set title
    Patients with Malignant Breast Lesions
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with Malignant Breast Lesionsb

    Subject analysis set title
    Patients with Benign Breast Lesions
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients with Benign Breast Lesionsb

    Primary: KDR Staining of Index Lesion versus CD31 Staining by Histopathology - Ovary

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    End point title
    		 KDR Staining of Index Lesion versus CD31 Staining by Histopathology - Ovary [1] [2]
    End point description
    The number of index lesions with KDR and CD31 staining scores of high, intermediate, or weak by IHC assessment for both malignant and benign ovarian lesions. Each of the 24 dosed patients had 1 index lesion identified by histopathology. Based on the histopathology analysis, 13 of the 24 (54.2%) index lesions were malignant and 11 (45.8%) lesions were benign.
    End point type
    Primary
    End point timeframe
    Postdose
    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: Descriptive statistics are provided in the descriptions of the Primary Endpoint Results. No other statistical analyses were planned for the efficacy endpoints as the study was exploratory.
    [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: Descriptive statistics are provided in the descriptions of the Primary Endpoint Results. No other statistical analyses were planned for the efficacy endpoints as the study was exploratory.
    End point values
    		 Ovary Patients
    Number of subjects analysed
    24
    Units: Number of Patients
        Patients with Malignant Ovarian Lesions
    13
        Patients with Benign Ovarian Lesions
    11
    No statistical analyses for this end point

    Primary: BR55 Enhancement of Index Lesion versus CD31 Staining by Histopathology Using a Dichotomized Scale – Ovary

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    End point title
    		 BR55 Enhancement of Index Lesion versus CD31 Staining by Histopathology Using a Dichotomized Scale – Ovary [3]
    End point description
    BR55 enhancement and CD31 staining of the ovarian index lesions. A BR55 enhancement score of the index lesion according to ultrasound images. BR55 enhancement scores of slight, moderate and strong enhancement were considered as Yes. All index lesions had CD31 staining. 13/13 (100%) malignant lesions had both CD31 staining and BR55 enhancement; among 11 benign lesions with CD31 staining, 9 (81.8%) had BR55 enhancement and 2 did not.
    End point type
    Primary
    End point timeframe
    Postdose
    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: Descriptive statistics are provided in the descriptions of the Primary Endpoint Results. No other statistical analyses were planned for the efficacy endpoints as the study was exploratory.
    End point values
    		 Patients with Malignant Ovarian Lesions Patients with Benign Ovarian Lesions
    Number of subjects analysed
    13
    11
    Units: Lesions
    number (not applicable)
        No
    0
    2
        Yes
    13
    9
        Total
    13
    11
    No statistical analyses for this end point

    Primary: KDR Staining of Index Lesion versus CD31 Staining by Histopathology - Breast

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    End point title
    		 KDR Staining of Index Lesion versus CD31 Staining by Histopathology - Breast [4] [5]
    End point description
    The number of index lesions with KDR and CD31 staining scores of high, intermediate, or weak by IHC assessment for both malignant and benign breast lesions. Each of the 21 dosed patients had 1 index lesion identified by histopathology. Based on the histopathology analysis, 17 of 21 (81.0%) index lesions were malignant and 4 (19.0%) index lesions were benign.
    End point type
    Primary
    End point timeframe
    Postdose
    Notes
    [4] - 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: Descriptive statistics are provided in the descriptions of the Primary Endpoint Results. No other statistical analyses were planned for the efficacy endpoints as the study was exploratory.
    [5] - 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: Descriptive statistics are provided in the descriptions of the Primary Endpoint Results. No other statistical analyses were planned for the efficacy endpoints as the study was exploratory.
    End point values
    		 Breast Patients
    Number of subjects analysed
    21
    Units: Lesions
    number (not applicable)
        Patients with Malignant Breast Lesions
    17
        Patients with Benign Breast Lesions
    4
    No statistical analyses for this end point

    Primary: BR55 Enhancement of Index Lesion versus CD31 Staining by Histopathology Using a Dichotomized Scale – Breast

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    End point title
    		 BR55 Enhancement of Index Lesion versus CD31 Staining by Histopathology Using a Dichotomized Scale – Breast [6]
    End point description
    BR55 enhancement and CD31 staining of the breast index lesions. A BR55 enhancement score of the index lesion according to ultrasound images. BR55 enhancement scores of slight, moderate and strong enhancement were considered as Yes. All index lesions had CD31 staining. 16/17 (94.1%) malignant lesions had both CD31 staining and BR55 enhancement and among the 4 benign lesions with CD31 staining, 2 lesions (50.0%) had BR55 enhancement and 2 (50.0%) had none.
    End point type
    Primary
    End point timeframe
    Postdose
    Notes
    [6] - 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: Descriptive statistics are provided in the descriptions of the Primary Endpoint Results. No other statistical analyses were planned for the efficacy endpoints as the study was exploratory.
    End point values
    		 Patients with Malignant Breast Lesions Patients with Benign Breast Lesions
    Number of subjects analysed
    17
    4
    Units: Lesions
    number (not applicable)
        No
    1
    2
        Yes
    16
    2
        Total
    17
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Patients were monitored for any untoward medical occurrences from the time of signing the Informed Consent through 72 hours after BR55 administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Ovarian
    Reporting group description
    		 -

    Reporting group title
    Breast
    Reporting group description
    		 -

    Serious adverse events
    		 Ovarian Breast
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ovarian Breast
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 24 (20.83%)
    7 / 21 (33.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 24 (4.17%)
    6 / 21 (28.57%)
         occurrences all number
    1
    6
    Gastrointestinal disorders
    Lip pruritus
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Oral discomfort
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2013
    The inclusion criteria was amended to also allow perimenopausal females to enroll, provided that they met the enrollment criteria and were not pregnant or breast-feeding.

    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
    For support, Contact us.
    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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