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    Clinical Trial Results:
    A Phase IIa, single centre, open label, proof of concept study concerning efficacy of the novel intravenous contrast agent SN132D in patients with suspected endometriosis.

    Summary
    EudraCT number
    		 2022-000652-11
    Trial protocol
    		 SE  
    Global end of trial date
    20 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2024
    First version publication date
    30 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SPAGOPIX-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05664828
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Spago Nanomedical AB
    Sponsor organisation address
    Scheelevagen 22, Lund, Sweden,
    Public contact
    mats.hansen@spagonanomedical.se, Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se
    Scientific contact
    mats.hansen@spagonanomedical.se, Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se
    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
    02 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the MRI enhancing properties of SN132D in participants with suspected endometriosis
    Protection of trial subjects
    GDPR followed. GCP Followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2022
    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
    Sweden: 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)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were prescreened with TUS

    Pre-assignment
    Screening details
    		 Patients with suspected endometriosis

    Period 1
    Period 1 title
    Active infusion baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 SN132D
    Arm description
    		 Dose of 20 µmol Mn/kg
    Arm type
    		 Experimental

    Investigational medicinal product name
    SN132D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    SN132D was administered as a 1-hour single i.v. infusion using a syringe pump with a saline carrier. Participants received a single i.v. infusion of SN132D at a dose of 20 µmol Mn/kg.

    Number of subjects in period 1
    		SN132D
    Started
    8
    Completed
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active infusion baseline
    Reporting group description
    		 -

    Reporting group values
    		 Active infusion baseline Total
    Number of subjects
    		 8 8
    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)
    		 8 8
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.9 ( 7.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
    Race
    Units: Subjects
        White
    		 7 7
        Asian
    		 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 6 6
    Body weight
    Units: kg
        arithmetic mean (standard deviation)
    		 72.3 ( 12.2 ) -
    Body mass index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.2 ( 4.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    SN132D
    Reporting group description
    		 Dose of 20 µmol Mn/kg

    Subject analysis set title
    MRI analysis set - baseline values
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The MRI analysis set consisted of all participants who received the IMP and for whom at least the predose MRI scan and 1 post-dose MRI scan had been performed. Results for individual participants at baseline.

    Subject analysis set title
    1h after end of MRI infusion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in the magnetic resonance imaging (MRI) analysis set who received the SND132D infusion 1 hour after the end of the SN132D infusion

    Subject analysis set title
    4h after end of MRI infusion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in the magnetic resonance imaging (MRI) analysis set who received the SND132D infusion 4 hours after the end of the SN132D infusion

    Subject analysis set title
    TUS analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in the magnetic resonance imaging (MRI) analysis set whose endometriosis lesions were evaluated at baseline by transvaginal ultrasound

    Primary: Contrast-to-noise ratio in endometriosis lesions vs endometrium reference tissue

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    End point title
    		 Contrast-to-noise ratio in endometriosis lesions vs endometrium reference tissue [1]
    End point description
    This primary endpoint covered the primary objective of evaluating the MRI enhancing properties of SN132D in participants with suspected endometriosis. The MRI enhancing effect was assessed by evaluating changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences. Following the baseline MRI scan, study participants received a single dose of SN132D, administered as an intravenous infusion over 1 hour. Post-dose MRI scans were performed twice, at 1 hour and 4 hours after the end of the infusion. The contrast-to-noise ratio in endometriosis lesions was compared to that of reference tissue in a) endometrium (prespecified reference tissue) and b) skeletal muscle (post hoc reference tissue). Note for lesion 9, no MRI scan was performed 4h after the end of the infusion for this participant.
    End point type
    Primary
    End point timeframe
    From baseline (pre-dose) to 4 hours after the end of the infusion. Magnetic resonance imaging (MRI) scans were performed at baseline (0h) and at 1h and 4h post-infusion.
    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 analysis was performed - imaging endpoints were presented using standard descriptive statistics for baseline and post-dose scans for individual participants.
    End point values
    		 MRI analysis set - baseline values 1h after end of MRI infusion 4h after end of MRI infusion
    Number of subjects analysed
    8
    8
    7
    Units: Ratio
    number (not applicable)
        Lesion 1 Endometrioma (right ovary)
    85.1
    46.5
    85.7
        Lesion 2 Endometrioma (left ovary)
    89.6
    55.1
    84.4
        Lesion 3 Endometrioma (right ovary)
    87.6
    108.0
    116.3
        Lesion 4 Endometrioma (left ovary)
    153.8
    115.4
    115.9
        Lesion 5 Superficial endometriosis (uterine)
    91.2
    63.3
    96.7
        Lesion 6 Deep endometriosis (abdominal wall)
    43.2
    44.0
    33.4
        Lesion 7 Deep endometriosis (uterine post)
    42.5
    16.6
    15.7
        Lesion 8 Deep endometriosis (uterine ant)
    47.5
    23.1
    19.0
        Lesion 9 Superficial endometriosis (rectal wall)
    22.8
    8.1
    0
        Lesion 10 Superficial endometriosis (rectal wall)
    5.5
    -11.5
    -11.6
        Lesion 11 deep endometriosis (rectal wall)
    -47.4
    -6.1
    -8.7
        Lesion 12 Endometrioma (left ovary)
    32.2
    44.2
    34.8
        Lesion 13 Endometrioma (left ovary)
    56.4
    62.7
    40.5
    No statistical analyses for this end point

    Primary: Signal-to-noise ratio in endometriosis lesions

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    End point title
    		 Signal-to-noise ratio in endometriosis lesions [2]
    End point description
    This primary endpoint covered the primary objective of evaluating the MRI enhancing properties of SN132D in participants with suspected endometriosis. The MRI enhancing effect was assessed by evaluating changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences. Following the baseline MRI scan, study participants received a single dose of SN132D, administered as an intravenous infusion over 1 hour. Post-dose MRI scans were performed twice, at 1 hour and 4 hours after the end of the infusion. The signal-to-noise ratio in endometriosis lesions was compared to that of reference tissue. Note for lesion 9, no MRI scan was performed 4h after the end of the infusion for this participant.
    End point type
    Primary
    End point timeframe
    From baseline (pre-dose) to 4 hours after the end of the infusion. Magnetic resonance imaging (MRI) scans were performed at baseline (0h) and at 1h and 4h post-infusion.
    Notes
    [2] - 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 analysis was performed - imaging endpoints were presented using standard descriptive statistics for baseline and post-dose scans for individual participants.
    End point values
    		 MRI analysis set - baseline values 1h after end of MRI infusion 4h after end of MRI infusion
    Number of subjects analysed
    8
    8
    7
    Units: Ratio
    number (not applicable)
        Lesion 1 Endometrioma (right ovary)
    170.9
    113.1
    192.8
        Lesion 2 Endometrioma (left ovary)
    202.2
    127.8
    196.5
        Lesion 3 Endometrioma (right ovary)
    103.0
    135.0
    144.4
        Lesion 4 Endometrioma (left ovary)
    181.3
    159.6
    152.0
        Lesion 5 Superficial endometriosis (uterine)
    121.5
    99.4
    149.3
        Lesion 6 Deep endometriosis (abdominal wall)
    121.5
    115.3
    103.1
        Lesion 7 Deep endometriosis (uterine post)
    105.6
    100.7
    92.8
        Lesion 8 Deep endometriosis (uterine ant)
    105.1
    93.6
    91.1
        Lesion 9 Superficial endometriosis (rectal wall)
    74.6
    99.9
    0
        Lesion 10 Superficial endometriosis (rectal wall)
    38.8
    53.3
    89.4
        Lesion 11 Deep endometriosis (rectal wall)
    56.7
    123.0
    92.4
        Lesion 12 Endometrioma (left ovary)
    139.5
    208.7
    156.1
        Lesion 13 Endometrioma (left ovary)
    224.4
    262.4
    217.9
    No statistical analyses for this end point

    Secondary: Compare the number, size and site of deep pelvic endometriosis lesions/endometriosis lesions obtained by SN132D imaging to TUS and clinically used non-contrast MRI

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    End point title
    		 Compare the number, size and site of deep pelvic endometriosis lesions/endometriosis lesions obtained by SN132D imaging to TUS and clinically used non-contrast MRI
    End point description
    Addresses the secondary objective of evaluating the diagnostic value of SN132D for detection of deep pelvic endometriosis lesions/endometriosis lesions in participants with suspected endometriosis. Following the baseline MRI scan, study participants received a single dose of SN132D by intravenous infusion over 1 hour. Post-dose MRI scans were performed twice, at 1 and 4 hours after the end of the infusion. Endometriosis lesions were measured and classified using the Enzian 2021 classification, a non-invasive and surgical description system for endometriosis. The diagnostic value of SN132D was evaluated by comparing the number, size and site of lesions obtained by SN132D imaging to transvaginal ultrasound and clinically used non-contrast MRI (observed at baseline, 0 h). P=peritoneum. O=ovary. T=tube. A=vagina/rectovaginal space. B=uterosacral ligaments/cardinal ligaments/pelvic sidewall. C=rectum. F=far location (uterine and other extragenital locations).
    End point type
    Secondary
    End point timeframe
    From baseline (pre-dose) to 4 hours after the end of the infusion. MRI scans were performed at baseline (0h) and at 1h and 4h post-infusion.
    End point values
    		 MRI analysis set - baseline values 1h after end of MRI infusion 4h after end of MRI infusion TUS analysis set
    Number of subjects analysed
    8
    8
    7
    8
    Units: Number of participants
        P0: no lesions
    8
    8
    7
    7
        P1: sum of all diameters <3 cm
    0
    0
    0
    0
        P2: sum of all diameters 3-7 cm
    0
    0
    0
    1
        P3: sum of all diameters >7 cm
    0
    0
    0
    0
        O0 (left): no lesions
    3
    2
    3
    3
        O1 (left): sum of all diameters <3 cm
    1
    3
    1
    2
        O2 (left): sum of all diameters 3-7 cm
    3
    2
    1
    2
        O3 (left): sum of all diameters >7 cm
    1
    1
    2
    1
        O0 (right): no lesions
    3
    2
    2
    3
        O1 (right): sum of all diameters <3 cm
    4
    5
    4
    2
        O2 (right): sum of all diameters 3-7 cm
    1
    1
    1
    2
        O3 (right): sum of all diameters >7 cm
    0
    0
    0
    0
        O (right) missing
    0
    0
    0
    1
        T0 (left): no lesions
    1
    3
    1
    1
        T1 (left): mild
    3
    1
    1
    0
        T2 (left): moderate
    3
    3
    4
    5
        T3 (left): severe
    1
    1
    1
    2
        T0 (right): no lesions
    2
    3
    1
    1
        T1 (right): mild
    3
    4
    2
    0
        T2 (right): moderate
    2
    0
    4
    4
        T3 (right): severe
    1
    1
    0
    2
        T (right) missing
    0
    0
    0
    1
        A0: no lesions
    4
    4
    4
    7
        A1: <1 cm
    0
    0
    1
    0
        A2: 1−3 cm
    4
    3
    2
    1
        A3: >3 cm
    0
    1
    0
    0
        B0 (left): no lesions
    1
    2
    2
    0
        B1 (left): <1 cm
    1
    0
    0
    1
        B2 (left): 1−3 cm
    5
    5
    4
    7
        B3 (left): >3 cm
    1
    1
    1
    0
        B0 (right): no lesions
    0
    3
    2
    5
        B1 (right): <1 cm
    2
    0
    0
    0
        B2 (right): 1−3 cm
    6
    5
    5
    3
        B3 (right): >3 cm
    0
    0
    0
    0
        C0: no lesions
    3
    4
    4
    1
        C1: <1 cm
    1
    0
    0
    0
        C2: 1−3 cm
    1
    1
    1
    6
        C3: >3 cm
    3
    3
    2
    1
        FA: Adenomyosis
    1
    0
    0
    3
        FB: Bladder
    0
    0
    0
    0
        FI: Intestinum
    0
    0
    0
    3
        FU: Ureter
    0
    0
    0
    0
        FO: Other location
    4
    4
    3
    1
    No statistical analyses for this end point

    Post-hoc: Contrast-to-noise ratio in endometriosis lesions vs skeletal muscle reference tissue

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    End point title
    		 Contrast-to-noise ratio in endometriosis lesions vs skeletal muscle reference tissue
    End point description
    This endpoint covered the primary objective of evaluating the MRI enhancing properties of SN132D in participants with suspected endometriosis. The MRI enhancing effect was assessed by evaluating changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences. Following the baseline MRI scan, study participants received a single dose of SN132D, administered as an intravenous infusion over 1 hour. Post-dose MRI scans were performed twice, at 1 hour and 4 hours after the end of the infusion. The contrast-to-noise ratio in endometriosis lesions was compared to that of reference tissue in a) endometrium (prespecified) and b) skeletal muscle (post hoc reference tissue). Note for lesion 9, no MRI scan was performed 4h after the end of the infusion for this participant.
    End point type
    Post-hoc
    End point timeframe
    From baseline (pre-dose) to 4 hours after the end of the infusion. Magnetic resonance imaging (MRI) scans were performed at baseline (0h) and at 1h and 4h post-infusion.
    End point values
    		 MRI analysis set - baseline values 1h after end of MRI infusion 4h after end of MRI infusion
    Number of subjects analysed
    8
    8
    7
    Units: Ratio
    number (not applicable)
        Lesion 1 Endometrioma (right ovary)
    112.7
    68.5
    119.6
        Lesion 2 Endometrioma (left ovary)
    115.1
    71.4
    107.1
        Lesion 3 Endometrioma (right ovary)
    64.2
    85.5
    81.6
        Lesion 4 Endometrioma (left ovary)
    110.0
    94.7
    91.2
        Lesion 5 Superficial endometriosis (uterine)
    58.8
    20.8
    39.9
        Lesion 6 Deep endometriosis (abdominal wall)
    8.7
    9.2
    9.4
        Lesion 7 Deep endometriosis (uterine post)
    6.3
    19.1
    15.4
        Lesion 8 Deep endometriosis (uterine ant)
    8.0
    -5.7
    -5.7
        Lesion 9 Superficial endometriosis (rectal wall)
    -4.7
    4.3
    0
        Lesion 10 Superficial endometriosis (rectal wall)
    -0.2
    4.1
    -2.3
        Lesion 11 Deep endometriosis (rectal wall)
    -35.2
    12.9
    12.0
        Lesion 12 Endometrioma (left ovary)
    94.3
    140.4
    101.9
        Lesion 13 Endometrioma (left ovary)
    109.3
    98.3
    87.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs, including serious AEs) were collected from the start of IMP administration on day 1 (visit 2) until the follow-up visit (visit 3) on day 3-14.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Full analysis set (FAS)
    Reporting group description
    		 The FAS consisted of all participants who received at least 1 dose of IMP. This population was used as the safety analysis set.

    Serious adverse events
    		 Full analysis set (FAS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (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
    		 Full analysis set (FAS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 8 (87.50%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    5 / 8 (62.50%)
         occurrences all number
    5
    Hypertension
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    5 / 8 (62.50%)
         occurrences all number
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 8 (75.00%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    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 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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