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    Clinical Trial Results:
    A MULTICENTRE, RANDOMISED, DOSE-CONFIRMATION, FACTORIAL PHASE II STUDY TO EVALUATE THE OPTIMAL DOSE OF 68Ga-OPS202 AS A PET IMAGING AGENT IN SUBJECTS WITH GASTROENTEROPANCREATIC NEUROENDOCRINE TUMOUR (GEP-NET)

    Summary
    EudraCT number
    		 2016-004928-39
    Trial protocol
    		 DK   NL   AT  
    Global end of trial date
    05 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Aug 2020
    First version publication date
    20 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D-FR-01070-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03220217
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma
    Sponsor organisation address
    65 quai Georges Gorse, Boulogne-Billancourt, France, 92100
    Public contact
    Medical Director, Ipsen Pharma, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Pharma, clinical.trials@ipsen.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
    05 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To define the optimal dose range for peptide mass and radioactivity of Gallium-68 (68Ga)-satoreotide trizoxetan (formerly 68Ga-OPS202) based on detected lesions in adult subjects with somatostatin receptor subtype 2 (sstr2) positive gastroenteropancreatic neuroendocrine tumour (GEP-NET).
    Protection of trial subjects
    The study was conducted under the provisions of the Declaration of Helsinki, and in accordance with the International Conference on Harmonisation Consolidated Guideline on Good Clinical Practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Sep 2017
    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
    United States: 2
    Country: Number of subjects enrolled
    Austria: 14
    Country: Number of subjects enrolled
    Denmark: 13
    Worldwide total number of subjects
    29
    EEA total number of subjects
    27
    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)
    15
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This dose-confirmation, 2 × 3 factorial Phase II study was conducted at 4 centres between September 2017 and August 2019. Adult subjects with sstr2-positive GEP-NET were randomised to investigational imaging product with 68Ga-satoreotide trizoxetan.

    Pre-assignment
    Screening details
    		 The Screening Visit (Visit 1) was performed within 2 weeks prior to the first 68Ga-satoreotide trizoxetan administration. Subjects' eligibility was re-checked by the investigator at Visit 2 (Day 1) before randomisation to 1 of 3 study arms (A, B or C) with differing 68Ga-satoreotide trizoxetan peptide mass dose and radioactivity dose ranges.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study however independent readers who evaluated 68Ga-satoreotide trizoxetan positron emission tomography (PET)/computed tomography (CT) images were blinded to investigator site, clinical status of the subject, peptide mass dose, radioactivity dose and the temporal sequence of dosing.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq
    Arm description
    		 Subjects received a single intravenous (i.v.) injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 micrograms (μg) and a radioactivity dose range of 40-80 Megabecquerel (MBq) on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-satoreotide trizoxetan
    Investigational medicinal product code
    Other name
    68Ga-OPS202, 68Ga-IPN01070
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Visit 2/Dose 1: A single i.v. injection over one minute of 68Ga-satoreotide trizoxetan (peptide mass range 5-20 μg and radioactivity dose range 40-80 MBq). Visit 3/Dose 2: A single i.v. injection over one minute of 68Ga-satoreotide trizoxetan (peptide mass range 30-45 μg and radioactivity dose range 100-140 MBq).

    Arm title
    		 Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq
    Arm description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-satoreotide trizoxetan
    Investigational medicinal product code
    Other name
    68Ga-OPS202, 68Ga-IPN01070
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Visit 2/Dose 1: A single i.v. injection over one minute of 68Ga-satoreotide trizoxetan (peptide mass range 5-20 μg and radioactivity dose range 100-140 MBq). Visit 3/Dose 2: A single i.v. injection over one minute of 68Ga-satoreotide trizoxetan (peptide mass range 30-45 μg and radioactivity dose range 160-200 MBq).

    Arm title
    		 Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
    Arm description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-satoreotide trizoxetan
    Investigational medicinal product code
    Other name
    68Ga-OPS202, 68Ga-IPN01070
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Visit 2/Dose 1: A single i.v. injection over one minute of 68Ga-satoreotide trizoxetan (peptide mass range 5-20 μg and radioactivity dose range 160-200 MBq). Visit 3/Dose 2: A single i.v. injection over one minute of 68Ga-satoreotide trizoxetan (peptide mass range 30-45 μg and radioactivity dose range 40-80 MBq).

    Number of subjects in period 1
    		Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
    Started
    8
    10
    11
    Completed
    8
    9
    10
    Not completed
    0
    1
    1
         Consent withdrawn by subject
    -
    1
    -
         Subject Missed Procedure
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq
    Reporting group description
    		 Subjects received a single intravenous (i.v.) injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 micrograms (μg) and a radioactivity dose range of 40-80 Megabecquerel (MBq) on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).

    Reporting group title
    Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).

    Reporting group title
    Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).

    Reporting group values
    		 Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq Total
    Number of subjects
    		 8 10 11 29
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 4 8 15
        From 65-84 years
    		 5 6 3 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.5 ( 11.1 ) 67.6 ( 6.4 ) 60.7 ( 12.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 6 2 10
        Male
    		 6 4 9 19

    End points

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    End points reporting groups
    Reporting group title
    Arm A: 5-20 µg/40-80 MBq Then 30-45 µg/100-140 MBq
    Reporting group description
    		 Subjects received a single intravenous (i.v.) injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 micrograms (μg) and a radioactivity dose range of 40-80 Megabecquerel (MBq) on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 100-140 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).

    Reporting group title
    Arm B: 5-20 µg/100-140 MBq Then 30-45 µg/160-200 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 100-140 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range of 160-200 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).

    Reporting group title
    Arm C: 5-20 µg/160-200 MBq Then 30-45 µg/40-80 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg and a radioactivity dose range of 160-200 MBq on Visit 2 (Day 1). After 15 to 21 days at Visit 3 (Days 16 to 22), subjects received a second i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq. Both injections were followed by PET/CT scan imaging 1 hour post dosing (up to 80 min).

    Subject analysis set title
    Arm A: 5-20 μg/40-80 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.

    Subject analysis set title
    Arm A: 30-45 μg/100-140 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.

    Subject analysis set title
    Arm B: 5-20 μg/100-140 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.

    Subject analysis set title
    Arm B: 30-45 μg/160-200 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.

    Subject analysis set title
    Arm C: 5-20 μg/160-200 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.

    Subject analysis set title
    Arm C: 30-45 μg/40-80 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.

    Subject analysis set title
    Peptide Mass Dose Range 5-20 μg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 5-20 μg on Visit 2 (Day 1).

    Subject analysis set title
    Peptide Mass Dose Range 30-45 μg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects from Arms A, B and C who received an injection of 68Ga-satoreotide trizoxetan with a peptide mass dose range of 30-45 μg on Visit 3 (Days 16-22).

    Subject analysis set title
    Radioactivity Dose Range 40-80 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects from Arms A and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose of 40-80 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).

    Subject analysis set title
    Radioactivity Dose Range 100-140 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects from Arms A and B who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 100-140 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).

    Subject analysis set title
    Radioactivity Dose Range 160-200 MBq
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects from Arms B and C who received an injection of 68Ga-satoreotide trizoxetan with a radioactivity dose range of 160-200 MBq on either Visit 2 (Day 1) or on Visit 3 (Days 16-22).

    Primary: Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges

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    End point title
    		 Relative Lesion Counts Presented by Combination of Injected Peptide/Radioactivity Dose Ranges [1]
    End point description
    For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by standard-of-truth (SoT). The SoT in this study was the contrast enhanced (ce)CT scan images acquired at Visit 2 (Day 1) and Visit 3 (Days 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs and per target organ by each combination of injected peptide/radioactivity dose ranges after the 1st and 2nd injections.
    End point type
    Primary
    End point timeframe
    Day 1 and Days 16 to 22
    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: Only descriptive analyses were performed for the primary end point as per the protocol.
    End point values
    		 Arm A: 5-20 μg/40-80 MBq Arm A: 30-45 μg/100-140 MBq Arm B: 5-20 μg/100-140 MBq Arm B: 30-45 μg/160-200 MBq Arm C: 5-20 μg/160-200 MBq Arm C: 30-45 μg/40-80 MBq
    Number of subjects analysed
    8 [2]
    8 [3]
    8 [4]
    8 [5]
    8 [6]
    8 [7]
    Units: Relative Lesion Count
    median (full range (min-max))
        PET/CT: All Organs
    3.6 (0.73 to 15.00)
    3.8 (1.71 to 13.5)
    2.1 (0.64 to 4.41)
    2.6 (0.82 to 5.25)
    2.7 (0.91 to 16.25)
    2.5 (0.82 to 9.75)
        PET/CT: Liver
    2.1 (0.73 to 9.00)
    3.0 (2.00 to 8.00)
    2.9 (0.83 to 8.00)
    3.5 (1.50 to 11.00)
    2.4 (0.86 to 7.5)
    2.6 (0.76 to 5.17)
        PET/CT: Lymph Nodes
    2.0 (1.80 to 3.00)
    2.0 (0.40 to 3.00)
    1.00 (0.00 to 8.00)
    0.9 (0.00 to 12.00)
    2.2 (1.25 to 5.00)
    1.6 (1.00 to 2.00)
        PET: All Organs
    2.6 (0.73 to 19.00)
    3.9 (1.00 to 14.50)
    2.2 (1.00 to 4.50)
    2.6 (1.50 to 4.75)
    2.8 (0.91 to 13.50)
    2.7 (0.68 to 7.50)
        PET: Liver
    2.6 (0.73 to 5.00)
    3.3 (1.00 to 7.00)
    2.9 (0.67 to 7.00)
    3.4 (1.33 to 9.00)
    2.4 (0.86 to 7.00)
    2.3 (0.62 to 6.00)
        PET: Lymph Nodes
    2.0 (1.80 to 3.00)
    2.0 (1.60 to 4.00)
    2.2 (0.50 to 10.0)
    2.0 (0.50 to 14.00)
    3.8 (1.00 to 6.00)
    3.1 (0.75 to 4.00)
    Notes
    [2] - Except liver (n=5) and lymph nodes (n=3)
    [3] - Except liver (n=5) and lymph nodes (n=3)
    [4] - Except liver (n=4) and lymph nodes (n=6)
    [5] - Except liver (n=4) and lymph nodes (PET/CT n=6, PET n=3)
    [6] - Except lymph nodes (n=4)
    [7] - Except lymph nodes (n=4)
    No statistical analyses for this end point

    Primary: Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges

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    End point title
    		 Relative Lesion Counts Presented by Peptide Mass and Radioactivity Dose Ranges [8]
    End point description
    For each combination of injected peptide/radioactivity dose range, relative lesion counts were measured as the ratio of the number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT and PET readings to the number of lesions assessed by SoT. The SoT in this study was the ceCT scan images acquired at Visit 2 (Day 1) and Visit 3 (Day 16 to 22). Relative lesion counts for PET/CT and PET readings are presented for all organs and per target organ by both peptide mass range and radioactivity dose range.
    End point type
    Primary
    End point timeframe
    Day 1 and Days 16 to 22
    Notes
    [8] - 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: Only descriptive analyses were performed for the primary end point as per the protocol.
    End point values
    		 Peptide Mass Dose Range 5-20 μg Peptide Mass Dose Range 30-45 μg Radioactivity Dose Range 40-80 MBq Radioactivity Dose Range 100-140 MBq Radioactivity Dose Range 160-200 MBq
    Number of subjects analysed
    24 [9]
    24 [10]
    16 [11]
    16 [12]
    16 [13]
    Units: Relative Lesion Count
    median (full range (min-max))
        PET/CT: All Organs
    2.7 (0.64 to 16.25)
    2.7 (0.82 to 13.50)
    3.1 (0.73 to 15.00)
    2.6 (0.64 to 13.50)
    2.6 (0.82 to 16.25)
        PET/CT: Liver
    2.3 (0.73 to 9.00)
    3.0 (0.76 to 11.00)
    2.2 (0.73 to 9.00)
    3.0 (0.83 to 8.00)
    2.7 (0.86 to 11.00)
        PET/CT: Lymph Nodes
    2.0 (0.00 to 8.00)
    1.3 (0.00 to 12.00)
    2.0 (1.00 to 3.00)
    1.3 (0.00 to 8.00)
    1.3 (0.00 to 12.00)
        PET: All Organs
    2.6 (0.73 to 19.00)
    2.8 (0.68 to 14.50)
    2.6 (0.68 to 19.00)
    2.8 (1.00 to 14.50)
    2.7 (0.91 to 13.50)
        PET: Liver
    2.6 (0.67 to 7.00)
    2.8 (0.62 to 9.00)
    2.6 (0.62 to 6.00)
    3.3 (0.67 to 7.00)
    2.8 (0.86 to 9.00)
        PET: Lymph Nodes
    2.3 (0.50 to 10.00)
    2.0 (0.50 to 14.00)
    2.7 (0.75 to 4.00)
    2.0 (0.50 to 10.00)
    2.2 (0.50 to 14.00)
    Notes
    [9] - Except liver (n=17) and lymph nodes (n=13)
    [10] - Except liver (n=17) and lymph nodes (n=13)
    [11] - Except liver (n=13) and lymph nodes (n=7)
    [12] - Except liver and lymph nodes (n=9)
    [13] - Except liver (n=12) and lymph nodes (n=10)
    No statistical analyses for this end point

    Secondary: Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range

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    End point title
    		 Image Quality as Assessed by Tumour-To-Background Ratio Presented by Combination of Injected Peptide/Radioactivity Dose Range
    End point description
    For each PET assessment, image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by mean standardised uptake value (SUVmean) of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for liver and lymph nodes for each combination of injected peptide/radioactivity dose range. Insufficient data was available to calculate median (full range) values for bone and lungs.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Arm A: 5-20 μg/40-80 MBq Arm A: 30-45 μg/100-140 MBq Arm B: 5-20 μg/100-140 MBq Arm B: 30-45 μg/160-200 MBq Arm C: 5-20 μg/160-200 MBq Arm C: 30-45 μg/40-80 MBq
    Number of subjects analysed
    8 [14]
    8 [15]
    8 [16]
    8 [17]
    8 [18]
    8 [19]
    Units: Ratio
    median (full range (min-max))
        Liver
    5.5 (3.75 to 12.88)
    4.7 (3.56 to 9.96)
    4.2 (3.10 to 24.95)
    4.2 (3.05 to 29.33)
    3.6 (2.13 to 10.75)
    4.0 (3.07 to 22.48)
        Lymph Nodes
    7.4 (3.87 to 16.98)
    6.2 (3.22 to 13.76)
    5.1 (2.55 to 16.10)
    8.2 (1.54 to 13.70)
    5.7 (3.40 to 12.84)
    4.5 (3.50 to 18.69)
    Notes
    [14] - liver (n=5) and lymph nodes (n=3)
    [15] - liver (n=5) and lymph nodes (n=3)
    [16] - liver (n=5) and lymph nodes (n=6)
    [17] - liver (n=5) and lymph nodes (n=6)
    [18] - lymph nodes (n=5)
    [19] - lymph nodes (n=5)
    No statistical analyses for this end point

    Secondary: Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges

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    End point title
    		 Image Quality as Assessed by Tumour-To-Background Ratio Presented by Peptide Mass and Radioactivity Dose Ranges
    End point description
    For each PET assessment image quality was quantitatively measured by the tumour-to-background ratio, obtained using the mean of all lesions tumour-to-backgrounds, for each of the following organs; liver, lymph nodes, bone and lungs. The tumour-to-background ratio was computed by SUVmean of the lesion divided by the SUVmean of the subject's reference tissue (tumour-free liver or aortic blood). A high tumour-to-background ratio indicates high effectiveness of 68Ga-satoreotide trizoxetan as a diagnostic agent. Tumour-to-background ratios are presented for liver and lymph nodes for each peptide mass and radioactivity dose range. Insufficient data was available to calculate median (full range) values for bone and lungs.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Peptide Mass Dose Range 5-20 μg Peptide Mass Dose Range 30-45 μg Radioactivity Dose Range 40-80 MBq Radioactivity Dose Range 100-140 MBq Radioactivity Dose Range 160-200 MBq
    Number of subjects analysed
    24 [20]
    24 [21]
    16 [22]
    16 [23]
    16 [24]
    Units: Ratio
    median (full range (min-max))
        Liver
    4.1 (2.13 to 24.95)
    4.3 (3.05 to 29.33)
    4.3 (3.07 to 22.48)
    4.4 (3.10 to 24.95)
    4.1 (2.13 to 29.33)
        Lymph Nodes
    5.5 (2.55 to 16.98)
    5.2 (1.54 to 18.69)
    4.9 (3.50 to 18.69)
    5.3 (2.55 to 16.10)
    5.7 (1.54 to 13.70)
    Notes
    [20] - liver (n=18) and lymph nodes (n=14)
    [21] - liver (n=18) and lymph nodes (n=14)
    [22] - liver (n=13) and lymph nodes (n=8)
    [23] - liver (n=10) and lymph nodes (n=9)
    [24] - liver (n=13) and lymph nodes (n=11)
    No statistical analyses for this end point

    Secondary: Image Quality as Assessed by Independent Blinded Readers Quality Score

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    End point title
    		 Image Quality as Assessed by Independent Blinded Readers Quality Score
    End point description
    A qualitative analysis of the image was assessed by 2 independent blinded readers using a quality score (performed as a back-up to the quantitative quality measured by tumour-to-background analysis). For each PET/CT and PET assessment, each independent blinded reader performed a direct comparison of the 2 scans from Visit 2 and Visit 3. They noted which scan provided superior images based on overall image quality and lesion count and attributed a score for each assessment. The score for the assessment having superior images was set to "1", and score for the assessment not selected was set to "0". In case of equal quality, both assessments had a score of "1". The image quality score for PET/CT and PET readings by total sum of readers' scores by peptide mass and radioactivity dose range combination are presented. Score ranges from 0-16 (number of scans analysed) with higher score indicating more assessments class as superior.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Radioactivity Dose Range 40-80 MBq Radioactivity Dose Range 100-140 MBq Radioactivity Dose Range 160-200 MBq
    Number of subjects analysed
    16
    16
    16
    Units: Total Sum of Readers’ Score
    number (not applicable)
        PET/CT: Peptide mass 5-20 μg
    9
    10
    10
        PET/CT: Peptide mass 30-45 μg
    13
    14
    13
        PET: Peptide mass 5-20 μg
    7
    14
    13
        PET: Peptide mass 30-45 μg
    11
    15
    13
    No statistical analyses for this end point

    Secondary: Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges

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    End point title
    		 Lesion Maximum Standardised Uptake Value (SUVmax) Presented by Combination of Injected Peptide/Radioactivity Dose Ranges
    End point description
    For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that were confirmed by SoT assessment. In order to obtain a unique measure per organ, values of the SUVmax were computed within each of the following organs; liver, lymph nodes, bone and lungs. SUVmax results are presented for liver and lymph nodes for each combination of injected peptide/radioactivity dose range. Insufficient data was available to calculate median (full range) values for bone and lungs.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Arm A: 5-20 μg/40-80 MBq Arm A: 30-45 μg/100-140 MBq Arm B: 5-20 μg/100-140 MBq Arm B: 30-45 μg/160-200 MBq Arm C: 5-20 μg/160-200 MBq Arm C: 30-45 μg/40-80 MBq
    Number of subjects analysed
    8 [25]
    8 [26]
    8 [27]
    8 [28]
    8 [29]
    8 [30]
    Units: Unit-less measure
    median (full range (min-max))
        Liver
    24.2 (18.25 to 49.16)
    22.9 (18.01 to 59.83)
    9.5 (6.74 to 63.68)
    16.0 (9.56 to 78.43)
    12.4 (6.95 to 30.07)
    17.7 (10.62 to 30.28)
        Lymph Nodes
    24.7 (19.52 to 40.74)
    35.7 (16.69 to 41.11)
    28.5 (9.03 to 83.06)
    27.7 (5.25 to 53.79)
    13.8 (6.08 to 21.73)
    12.7 (6.15 to 21.33)
    Notes
    [25] - liver (n=5) and lymph nodes (n=3)
    [26] - liver (n=5) and lymph nodes (n=3)
    [27] - liver (n=5) and lymph nodes (n=6)
    [28] - liver (n=5) and lymph nodes (n=6)
    [29] - lymph nodes (n=5)
    [30] - lymph nodes (n=5)
    No statistical analyses for this end point

    Secondary: Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges

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    End point title
    		 Lesion SUVmax Presented by Peptide Mass and Radioactivity Dose Ranges
    End point description
    For each PET assessment, SUVmax was measured for each lesion, up to a maximum of 5 most avid lesions per organ that are confirmed by SoT assessment. In order to obtain a unique measure per organ, mean of the SUVmax was computed within each of the liver, lymph nodes, bone and lungs. SUVmax results are presented for liver and lymph nodes by both peptide mass range and radioactivity dose range. Insufficient data was available to calculate median (full range) values for bone and lungs.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Peptide Mass Dose Range 5-20 μg Peptide Mass Dose Range 30-45 μg Radioactivity Dose Range 40-80 MBq Radioactivity Dose Range 100-140 MBq Radioactivity Dose Range 160-200 MBq
    Number of subjects analysed
    24 [31]
    24 [32]
    16 [33]
    16 [34]
    16 [35]
    Units: Unit-less measure
    median (full range (min-max))
        Liver
    15.6 (6.74 to 63.68)
    21.1 (9.56 to 78.43)
    20.0 (10.62 to 49.16)
    20.1 (6.74 to 63.68)
    13.3 (6.95 to 78.43)
        Lymph Nodes
    20.6 (6.08 to 83.06)
    20.3 (5.25 to 53.79)
    20.4 (6.15 to 40.74)
    32.6 (9.03 to 83.06)
    18.6 (5.25 to 53.79)
    Notes
    [31] - liver (n= 18) and lymph nodes (n=14)
    [32] - liver (n= 18) and lymph nodes (n=14)
    [33] - liver (n= 13) and lymph nodes (n=8)
    [34] - liver (n= 10) and lymph nodes (n=9)
    [35] - liver (n= 13) and lymph nodes (n=11)
    No statistical analyses for this end point

    Secondary: Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range

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    End point title
    		 Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Combination of Injected Peptide/Radioactivity Dose Range
    End point description
    For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, liver, lymph nodes, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose ranges.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Arm A: 5-20 μg/40-80 MBq Arm A: 30-45 μg/100-140 MBq Arm B: 5-20 μg/100-140 MBq Arm B: 30-45 μg/160-200 MBq Arm C: 5-20 μg/160-200 MBq Arm C: 30-45 μg/40-80 MBq
    Number of subjects analysed
    8 [36]
    8 [37]
    8 [38]
    8 [39]
    8 [40]
    8 [41]
    Units: Lesions
    median (full range (min-max))
        PET/CT: Primary Site
    1.0 (0 to 1)
    1.0 (0 to 1)
    0.0 (0 to 1)
    0.5 (0 to 1)
    1.0 (0 to 1)
    1.0 (0 to 1)
        PET/CT: Liver
    8.5 (3 to 15)
    12.5 (3 to 22)
    8.0 (0 to 19)
    11.00 (0 to 21)
    14.5 (3 to 71)
    14.5 (3 to 93)
        PET/CT: Lymph Nodes
    4.0 (0 to 9)
    2.0 (0 to 6)
    4.0 (0 to 8)
    2.0 (0 to 12)
    6.0 (1 to 11)
    3.5 (1 to 10)
        PET/CT: Bone
    2.0 (1 to 6)
    1.0 (1 to 5)
    1.0 (0 to 55)
    1.0 (1 to 43)
    2.0 (1 to 10)
    3.0 (2 to 6)
        PET/CT: Lung
    0.0 (0 to 0)
    0.0 (0 to 0)
    0.0 (0 to 1)
    0.0 (0 to 2)
    0.0 (0 to 1)
    0.0 (0 to 0)
        PET: Primary Site
    1.0 (0 to 1)
    1.0 (0 to 1)
    1.0 (0 to 1)
    0.5 (0 to 1)
    1.0 (1 to 1)
    1.0 (1 to 1)
        PET: Liver
    7.5 (3 to 22)
    9.0 (3 to 23)
    8.0 (0 to 25)
    13.0 (0 to 26)
    14.0 (3 to 76)
    11.0 (3 to 78)
        PET: Lymph Nodes
    4.0 (0 to 9)
    4.0 (0 to 10)
    3.0 (0 to 21)
    2.0 (0 to 18)
    6.5 (1 to 10)
    4.5 (1 to 8)
        PET: Bone
    1.0 (1 to 1)
    1.0 (0 to 1)
    1.0 (0 to 43)
    1.0 (0 to 46)
    3.5 (2 to 15)
    3.0 (1 to 13)
        PET: Lung
    0.5 (0 to 2)
    0.0 (0 to 1)
    0.0 (0 to 2)
    2.0 (0 to 4)
    2.0 (0 to 4)
    0.0 (0 to 0)
    Notes
    [36] - Except lymph nodes (n=7), bone (n=3), lung (n=4)
    [37] - Except lymph nodes (n=7), bone (n=3), lung (n=4)
    [38] - Except liver, lymph nodes, bone (n=7), lung (n=5)
    [39] - Except liver, lymph nodes, bone (n=7), lung (n=5)
    [40] - Except bone (n=4), lung (n=3)
    [41] - Except bone (n=4), lung (n=3)
    No statistical analyses for this end point

    Secondary: Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges

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    End point title
    		 Absolute Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Presented by Peptide Mass and Radioactivity Dose Ranges
    End point description
    For each PET/CT and PET assessment, the absolute number of lesions detected by 68Ga-satoreotide trizoxetan were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The absolute number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented for all organs and per target organ by both peptide mass range and radioactivity dose range.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Peptide Mass Dose Range 5-20 μg Peptide Mass Dose Range 30-45 μg Radioactivity Dose Range 40-80 MBq Radioactivity Dose Range 100-140 MBq Radioactivity Dose Range 160-200 MBq
    Number of subjects analysed
    24 [42]
    24 [43]
    16 [44]
    16 [45]
    16 [46]
    Units: Lesions
    median (full range (min-max))
        PET/CT: Primary Site
    1.0 (0 to 1)
    1.0 (0 to 1)
    1.0 (0 to 1)
    0.5 (0 to 1)
    1.0 (0 to 1)
        PET/CT: Liver
    9.0 (0 to 71)
    13.0 (0 to 93)
    11.5 (3 to 93)
    11.0 (0 to 22)
    11.0 (0 to 71)
        PET/CT: Lymph Nodes
    4.5 (0 to 11)
    2.0 (0 to 12)
    4.0 (0 to 10)
    2.0 (0 to 8)
    4.0 (0 to 12)
        PET/CT: Bone
    1.0 (0 to 55)
    1.5 (1 to 43)
    3.0 (1 to 6)
    1.0 (0 to 55)
    1.0 (1 to 43)
        PET/CT: Lung
    0.0 (0 to 1)
    0.0 (0 to 2)
    0.0 (0 to 0)
    0.0 (0 to 1)
    0.0 (0 to 2)
        PET: Primary Site
    1.0 (0 to 1)
    1.0 (0 to 1)
    1.0 (0 to 1)
    1.0 (0 to 1)
    1.0 (0 to 1)
        PET: Liver
    9.0 (0 to 76)
    11.0 (0 to 78)
    10.0 (3 to 78)
    8.0 (0 to 25)
    13.0 (0 to 76)
        PET: Lymph Nodes
    6.0 (0 to 21)
    4.0 (0 to 18)
    4.0 (0 to 9)
    3.5 (0 to 21)
    6.0 (0 to 18)
        PET: Bone
    1.5 (0 to 43)
    1.0 (0 to 46)
    1.0 (1 to 13)
    1.0 (0 to 43)
    2.0 (0 to 46)
        PET: Lung
    0.5 (0 to 4)
    0.0 (0 to 4)
    0.0 (0 to 2)
    0.0 (0 to 2)
    2.0 (0 to 4)
    Notes
    [42] - Except liver (n=23), lymph nodes (n=22), bone (n=14) and lung (n=12)
    [43] - Except liver (n=23), lymph nodes (n=22), bone (n=14) and lung (n=12)
    [44] - Except lymph nodes (n=15), bone and lung (n=7)
    [45] - Except liver (n=15), lymph nodes (n=14), bone (n=10), and lung (n=9)
    [46] - Except liver and lymph nodes (n=15), bone (n=11) and lung (n=8)
    No statistical analyses for this end point

    Secondary: Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range

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    End point title
    		 Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Combination of Injected Peptide/Radioactivity Dose Range
    End point description
    For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites are presented by each combination of injected peptide/radioactivity dose ranges.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Arm A: 5-20 μg/40-80 MBq Arm A: 30-45 μg/100-140 MBq Arm B: 5-20 μg/100-140 MBq Arm B: 30-45 μg/160-200 MBq Arm C: 5-20 μg/160-200 MBq Arm C: 30-45 μg/40-80 MBq
    Number of subjects analysed
    8 [47]
    8 [48]
    8 [49]
    8 [50]
    8 [51]
    8 [52]
    Units: Lesions
    median (full range (min-max))
        PET/CT: Primary Site
    0.5 (-1 to 1)
    0.5 (-1 to 1)
    0.0 (-1 to 1)
    0.0 (0 to 1)
    0.5 (0 to 1)
    0.5 (0 to 1)
        PET/CT: Liver
    6.0 (-3 to 13)
    9.0 (3 to 14)
    8.0 (-1 to 19)
    10.0 (0 to 21)
    4.0 (-3 to 53)
    5.5 (-5 to 75)
        PET/CT: Lymph Nodes
    2.0 (0 to 8)
    0.0 (-3 to 4)
    0.0 (-3 to 7)
    0.0 (-2 to 11)
    3.0 (1 to 11)
    1.0 (0 to 10)
        PET/CT: Bone
    2.0 (1 to 6)
    1.0 (1 to 5)
    1.0 (0 to 43)
    1.0 (1 to 31)
    2.0 (1 to 10)
    3.0 (2 to 6)
        PET/CT: Lung
    0.0 (0 to 0)
    0.0 (0 to 0)
    0.0 (-1 to 1)
    0.0 (-1 to 1)
    0.0 (0 to 1)
    0.0 (0 to 0)
        PET: Primary Site
    0.5 (-1 to 1)
    0.5 (-1 to 1)
    0.5 (0 to 1)
    0.0 (-1 to 1)
    1.0 (0 to 1)
    1.0 (0 to 1)
        PET: Liver
    4.0 (-3 to 22)
    5.5 (0 to 21)
    8.0 (-2 to 25)
    11.0 (0 to 26)
    5.0 (-3 to 58)
    5.0 (-8 to 60)
        PET: Lymph Nodes
    2.0 (0 to 8)
    3.0 (0 to 10)
    1.0 (-2 to 18)
    1.0 (-2 to 13)
    5.5 (0 to 8)
    4.5 (-1 to 7)
        PET: Bone
    1.0 (1 to 1)
    1.0 (0 to 1)
    1.0 (0 to 31)
    1.0 (0 to 34)
    3.5 (2 to 15)
    3.0 (1 to 13)
        PET: Lung
    0.5 (0 to 2)
    0.0 (0 to 1)
    0.0 (-1 to 2)
    2.0 (-1 to 4)
    2.0 (0 to 4)
    0.0 (0 to 0)
    Notes
    [47] - Except lymph nodes (n=7), bone (n=3) and lung (n=4)
    [48] - Except lymph nodes (n=7), bone (n=3) and lung (n=4)
    [49] - Except liver, lymph nodes, bone (n=7), and lung (n=5)
    [50] - Except liver, lymph nodes, bone (n=7), and lung (n=5)
    [51] - Except bone (n=4), and lung (n=3)
    [52] - Except bone (n=4), and lung (n=3)
    No statistical analyses for this end point

    Secondary: Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges

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    End point title
    		 Difference in Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Compared to Lesions Detected by SoT Presented by Peptide Mass and Radioactivity Dose Ranges
    End point description
    For each PET/CT and PET assessment, the number of lesions detected by 68Ga-satoreotide trizoxetan and SoT (ceCT) were reported for each of the following anatomic sites; primary site of GEP-NET, lymph nodes, liver, axial/appendicular skeleton (bone) and lungs. The difference was calculated by number of lesions detected by 68Ga-satoreotide trizoxetan - number of lesions detected by ceCT scan. A positive difference indicates that more lesions were detected by 68Ga-satoreotide trizoxetan than by ceCT scan. A negative difference indicates that more lesions were detected by ceCT scan than by 68Ga-satoreotide trizoxetan. The difference in number of lesions for PET/CT and PET readings for the 5 anatomic sites results are presented by both peptide mass range and radioactivity dose range.
    End point type
    Secondary
    End point timeframe
    Day 1 and Days 16 to 22
    End point values
    		 Peptide Mass Dose Range 5-20 μg Peptide Mass Dose Range 30-45 μg Radioactivity Dose Range 40-80 MBq Radioactivity Dose Range 100-140 MBq Radioactivity Dose Range 160-200 MBq
    Number of subjects analysed
    24 [53]
    24 [54]
    16 [55]
    16 [56]
    16 [57]
    Units: Lesions
    median (full range (min-max))
        PET/CT: Primary Site
    0.0 (-1 to 1)
    0.0 (-1 to 1)
    0.5 (-1 to 1)
    0.0 (-1 to 1)
    0.0 (0 to 1)
        PET/CT: Liver
    7.0 (-3 to 53)
    10.0 (-5 to 75)
    5.5 (-5 to 75)
    8.0 (-1 to 19)
    10.0 (-3 to 53)
        PET/CT: Lymph Nodes
    2.0 (-3 to 11)
    1.0 (-3 to 11)
    2.0 (0 to 10)
    0.0 (-3 to 7)
    1.0 (-2 to 11)
        PET/CT: Bone
    1.0 (0 to 43)
    1.5 (1 to 31)
    3.0 (1 to 6)
    1.0 (0 to 43)
    1.0 (1 to 31)
        PET/CT: Lung
    0.0 (-1 to 1)
    0.0 (-1 to 1)
    0.0 (0 to 0)
    0.0 (-1 to 1)
    0.0 (-1 to 1)
        PET: Primary Site
    1.0 (-1 to 1)
    1.0 (-1 to 1)
    1.0 (-1 to 1)
    0.5 (-1 to 1)
    1.0 (-1 to 1)
        PET: Liver
    6.0 (-3 to 58)
    6.0 (-8 to 60)
    4.5 (-8 to 60)
    6.0 (-2 to 25)
    8.0 (-3 to 58)
        PET: Lymph Nodes
    4.5 (-2 to 18)
    3.5 (-2 to 13)
    4.0 (-1 to 8)
    2.0 (-2 to 18)
    5.0 (-2 to 13)
        PET: Bone
    1.5 (0 to 31)
    1.0 (0 to 34)
    1.0 (1 to 13)
    1.0 (0 to 31)
    2.0 (0 to 34)
        PET: Lung
    0.0 (-1 to 4)
    0.0 (-1 to 4)
    0.0 (0 to 2)
    0.0 (-1 to 2)
    2.0 (-1 to 4)
    Notes
    [53] - Except liver (n=23), lymph nodes (n=22), bone (n=14), and lung (n=12)
    [54] - Except liver (n=23), lymph nodes (n=22), bone (n=14), and lung (n=12)
    [55] - Except lymph nodes (n=15), bone (n=7), and lung (n=7)
    [56] - Except liver (n=15), lymph nodes (n=14), bone (n=10), and lung (n=9)
    [57] - Except liver, lymph nodes (n=15), bone (n=11), and lung (n=8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events (AEs) were recorded from Day 1 up to 14 days after the last dose of investigational imaging product (up to 36 days overall).
    Adverse event reporting additional description
    All subjects included in the Safety Population analysis received 2 injections of 68Ga-satoreotide trizoxetan during the study. AEs were allocated to each combination of injected peptide/radioactivity dose range according to the following rule: AEs were allocated to the last dose of 68Ga-satoreotide trizoxetan received, based on AE start date/time.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Arm A: 5-20 μg/40-80 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 40-80 MBq on Visit 2/Day 1.

    Reporting group title
    Arm A: 30-45 μg/100-140 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 100-140 MBq on Visit 3/Days 16 to 22.

    Reporting group title
    Arm B: 5-20 μg/100-140 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 100-140 MBq on Visit 2/Day 1.

    Reporting group title
    Arm B: 30-45 μg/160-200 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 160-200 MBq on Visit 3/Days 16 to 22.

    Reporting group title
    Arm C: 5-20 μg/160-200 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 5-20 μg and a radioactivity range of 160-200 MBq on Visit 2/Day 1.

    Reporting group title
    Arm C: 30-45 μg/40-80 MBq
    Reporting group description
    		 Subjects received a single i.v. injection of 68Ga-satoreotide trizoxetan with a peptide mass of 30-45 μg and a radioactivity range of 40-80 MBq on Visit 3/Days 16 to 22.

    Reporting group title
    Overall
    Reporting group description
    		 Total number of AEs experienced across all Arms.

    Serious adverse events
    		 Arm A: 5-20 μg/40-80 MBq Arm A: 30-45 μg/100-140 MBq Arm B: 5-20 μg/100-140 MBq Arm B: 30-45 μg/160-200 MBq Arm C: 5-20 μg/160-200 MBq Arm C: 30-45 μg/40-80 MBq Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A: 5-20 μg/40-80 MBq Arm A: 30-45 μg/100-140 MBq Arm B: 5-20 μg/100-140 MBq Arm B: 30-45 μg/160-200 MBq Arm C: 5-20 μg/160-200 MBq Arm C: 30-45 μg/40-80 MBq Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 8 (25.00%)
    4 / 8 (50.00%)
    4 / 9 (44.44%)
    6 / 9 (66.67%)
    3 / 10 (30.00%)
    5 / 10 (50.00%)
    18 / 27 (66.67%)
    Investigations
    Blood potassium increased
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    1
    Blood urine present
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    General disorders and administration site conditions
    Administration site pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    3
    Feeling cold
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    3
    Fatigue
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    4 / 27 (14.81%)
         occurrences all number
    0
    1
    0
    2
    0
    1
    4
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    2
    Constipation
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    2
    Vomiting
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    5 / 27 (18.52%)
         occurrences all number
    1
    2
    0
    2
    0
    1
    6
    Endocrine disorders
    Basedow's disease
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 May 2019
    The substantial changes were: • To update personnel (sponsor’s representative and medically responsible person). • To amend concomitant medications that were not allowed. • To amend conditions in which abnormalities in laboratory test values should be reported as AEs. • To add an interim analysis.

    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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