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    Clinical Trial Results:
    Al18F-NOTA-octreotide PET imaging of the somatostatin receptor in neuroendocrine tumors

    Summary
    EudraCT number
    		 2020-000549-15
    Trial protocol
    		 BE  
    Global end of trial date
    13 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2023
    First version publication date
    24 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    S63678
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04552847
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Christophe Deroose, University Hospitals Leuven, 0032 16343715, christophe.deroose@uzleuven.be
    Scientific contact
    Christophe Deroose, University Hospitals Leuven, 0032 16343715, christophe.deroose@uzleuven.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate the non-inferior diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-SSA PET, in NET patients
    Protection of trial subjects
    Female participants of childbearing potential must agree to use highly effective medically accepted contraceptive methods to prevent pregnancy.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    07 Oct 2020
    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
    Belgium: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    85
    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)
    45
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were contacted at the time when they were scheduled for or undergoing a 68Ga-DOTAsomatostatin analogue (68Ga-DOTA-SSA) PET/CT or other procedures at the nuclear medicine unit. They were also recruited by members of the study team during their contact with the patient.

    Pre-assignment
    Screening details
    		 Patients with cytologically/histologically confirmed neuroendocrine tumors of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin with at least 1 known tumoral lesion below the level of the submandibular and parotid glands and a routine clinical clinical 68Ga-DOTA-SSA PET within 3 months prior or after the study.

    Pre-assignment period milestones
    Number of subjects started
    		 85
    Number of subjects completed
    		 85

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PET/CT (Part A)
    Arm description
    		 Seventy-five NET patients who underwent a whole-body PET with low-dose CT scan 2 hours after Al18F-NOTA-octreotide injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]AlF-NOTA-octreotide
    Investigational medicinal product code
    Other name
    Al18F-NOTA-octreotide, [18F]AlF-OC, Al18F-OC
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 MBq/kg 1 day, single dose no treatment: diagnostic scanning

    Arm title
    		 PET/MR (Part B)
    Arm description
    		 Ten NET patients who underwent a whole-body PET/MR scan 2 hours after Al18F-NOTA-octreotide injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]AlF-NOTA-octreotide
    Investigational medicinal product code
    Other name
    Al18F-NOTA-octreotide, [18F]AlF-OC, Al18F-OC
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 MBq/kg 1 day, single dose no treatment: diagnostic scanning

    Number of subjects in period 1
    		PET/CT (Part A) PET/MR (Part B)
    Started
    75
    10
    Completed
    75
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PET/CT (Part A)
    Reporting group description
    		 Seventy-five NET patients who underwent a whole-body PET with low-dose CT scan 2 hours after Al18F-NOTA-octreotide injection.

    Reporting group title
    PET/MR (Part B)
    Reporting group description
    		 Ten NET patients who underwent a whole-body PET/MR scan 2 hours after Al18F-NOTA-octreotide injection.

    Reporting group values
    		 PET/CT (Part A) PET/MR (Part B) Total
    Number of subjects
    		 75 10 85
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 37 8 45
        From 65-84 years
    		 38 2 40
    Gender categorical
    Units: Subjects
        Female
    		 29 4 33
        Male
    		 46 6 52
    Primary tumor
    Units: Subjects
        Intestine
    		 45 4 49
        Pancreas
    		 18 2 20
        Lung
    		 7 2 9
        Unknown primary
    		 4 2 6
        Paraganglioma
    		 1 0 1
    Tumor grade
    Units: Subjects
        G1
    		 35 2 37
        G1/G2
    		 2 2 4
        G2
    		 34 6 40
        G3
    		 2 0 2
        NA
    		 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    PET/CT (Part A)
    Reporting group description
    		 Seventy-five NET patients who underwent a whole-body PET with low-dose CT scan 2 hours after Al18F-NOTA-octreotide injection.

    Reporting group title
    PET/MR (Part B)
    Reporting group description
    		 Ten NET patients who underwent a whole-body PET/MR scan 2 hours after Al18F-NOTA-octreotide injection.

    Subject analysis set title
    68Ga-DOTATATE/NOC (part A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Routine clinical 68Ga-DOTA-TATE or -NOC PET/CT scan of the patients in part A

    Subject analysis set title
    Al18F-NOTA-octreotide (part A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Al18F-NOTA-octreotide PET/CT scan of the patients in part A

    Subject analysis set title
    68Ga-DOTATATE (part A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with a routine clinical 68Ga-DOTATATE PET/CT scan in part A

    Subject analysis set title
    68Ga-DOTANOC (part A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with a routine clinical 68Ga-DOTANOC PET/CT scan in part A

    Subject analysis set title
    G1 (part A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with a tumor grade G1 in part A

    Subject analysis set title
    G2 (part A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with a tumor grade G2 in part A

    Subject analysis set title
    Primary: intestine (part A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with a tumor of intestinal origin in part A

    Subject analysis set title
    Primary: pancreas (part A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with a tumor of pancreatic origin in part A

    Primary: Differential Detection Ratio (DDR)

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    End point title
    		 Differential Detection Ratio (DDR) [1] [2]
    End point description
    The primary objective, i.e. non-inferiority of 18F-AlF-OC compared with 68Ga-DOTATATE/NOC, would be met if the lower margin of the 95% confidence interval (95% CI) for the mean DDR was higher than -15%.
    End point type
    Primary
    End point timeframe
    End of study
    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: The statistics for this endpoint are encompassed in the reported 95% confidence interval.
    [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: The statistics for this endpoint are encompassed in the reported 95% confidence interval.
    End point values
    		 PET/CT (Part A)
    Number of subjects analysed
    75
    Units: percent
        arithmetic mean (confidence interval 95%)
    15.8 (9.6 to 22.0)
    No statistical analyses for this end point

    Secondary: Detection rate analysis on the organ level (DR data - part A)

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    End point title
    		 Detection rate analysis on the organ level (DR data - part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: mean DR (%)
    number (not applicable)
        Liver
    60.3
    93.3
        Bone
    79.8
    77.0
        Lymph nodes
    74.1
    96.0
        Lung
    73.6
    98.1
        Peritoneum
    55.5
    89.3
        Pancreas
    84.6
    100.0
        Pleura
    50.0
    66.7
        Small intestine
    78.8
    90.9
        Rectum
    100.0
    100.0
        Soft tissue
    62.5
    100.0
        Muscle
    77.6
    85.3
        Heart
    100.0
    100.0
        Salivary glands
    0.0
    100.0
        Breast
    100.0
    100.0
        Paraganglia
    100.0
    100.0
        Thyroid
    0.0
    100.0
        Stomach
    100.0
    100.0
        All (incl. head region)
    75.7
    91.4
        All (excl. head region)
    75.3
    91.1
    Statistical analysis title
    		 Comparison DR Liver lesions
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.00001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - 54 patients had liver lesions
    Statistical analysis title
    		 Comparison DR Bone lesions
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    P-value
    		 = 0.78
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - 50 patients had bone lesions
    Statistical analysis title
    		 Comparison DR Lymph node lesions
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 < 0.00001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [5] - 63 patients had lymph node lesions
    Statistical analysis title
    		 Comparison DR Lung lesions
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    P-value
    		 = 0.027
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [6] - 18 patients had lung lesions
    Statistical analysis title
    		 Comparison DR Peritoneum lesions
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [7] - 28 patients had peritoneal lesions
    Statistical analysis title
    		 Comparison DR Pancreas lesions
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    P-value
    		 = 0.1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [8] - 13 patients had pancreas lesions
    Statistical analysis title
    		 Comparison DR All lesions (incl. head region)
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.00001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison DR All lesions (excl. head region)
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.00001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Detection rate analysis on the organ level (DDR data - part A)

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    End point title
    		 Detection rate analysis on the organ level (DDR data - part A) [9]
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    Notes
    [9] - 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: The statistics for this endpoint are encompassed in the reported 95% confidence interval.
    End point values
    		 PET/CT (Part A)
    Number of subjects analysed
    75
    Units: percent
    arithmetic mean (confidence interval 95%)
        Liver
    33.1 (21.7 to 44.4)
        Bone
    -2.8 (-17.8 to 12.2)
        Lymph nodes
    21.9 (14.0 to 29.8)
        Lung
    24.6 (3.3 to 45.8)
        Peritoneum
    33.8 (11.7 to 55.9)
        Pancreas
    15.4 (-3.7 to 34.4)
    No statistical analyses for this end point

    Secondary: DDR analysis according to routine 68Ga-DOTA-SSA tracer (part A)

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    End point title
    		 DDR analysis according to routine 68Ga-DOTA-SSA tracer (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE (part A) 68Ga-DOTANOC (part A)
    Number of subjects analysed
    56
    19
    Units: percent
        arithmetic mean (confidence interval 95%)
    11.8 (4.3 to 19.3)
    27.5 (17.8 to 37.1)
    No statistical analyses for this end point

    Secondary: DR analysis 68Ga-DOTATATE subgroup (part A)

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    End point title
    		 DR analysis 68Ga-DOTATATE subgroup (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 Al18F-NOTA-octreotide (part A) 68Ga-DOTATATE (part A)
    Number of subjects analysed
    56
    56
    Units: mean DR (%)
    number (not applicable)
        Liver
    92.3
    57.7
        Bone
    71.4
    90.5
        Lymph nodes
    94.7
    75.0
        Lung
    97.6
    73.1
        Peritoneum
    87.6
    53.1
        Pancreas
    100.0
    85.0
        Pleura
    33.3
    100.0
        Small intestine
    100.0
    78.8
        Rectum
    100.0
    100.0
        Soft tissue
    100.0
    50.0
        MUscle
    80.4
    70.1
        Heart
    100.0
    100.0
        Salivary glands
    100.0
    0.0
        Breast
    100.0
    100.0
        Paraganglia
    100.0
    100.0
        Thyroid
    100.0
    0.0
        Stomach
    100.0
    100.0
        All
    89.8
    77.9
    Statistical analysis title
    		 Comparison DR Liver lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTATATE (part A)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [10] - 38 patients had liver lesions
    Statistical analysis title
    		 Comparison DR Bone lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTATATE (part A)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    P-value
    		 = 0.02
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [11] - 39 patients had bone lesions
    Statistical analysis title
    		 Comparison DR Lymph node lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTATATE (part A)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [12] - 47 patients had lymph node lesions
    Statistical analysis title
    		 Comparison DR Lung lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTATATE (part A)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    P-value
    		 = 0.046
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [13] - 14 patients had lung lesions
    Statistical analysis title
    		 Comparison DR Peritoneum lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTATATE (part A)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [14]
    P-value
    		 = 0.019
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [14] - 24 patients had peritoneal lesions
    Statistical analysis title
    		 Comparison DR Pancreas lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTATATE (part A)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [15]
    P-value
    		 = 0.18
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [15] - 10 patients had pancreas lesions
    Statistical analysis title
    		 Comparison DR All lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTATATE (part A)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.002
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: DR analysis 68Ga-DOTANOC subgroup (part A)

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    End point title
    		 DR analysis 68Ga-DOTANOC subgroup (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 Al18F-NOTA-octreotide (part A) 68Ga-DOTANOC (part A)
    Number of subjects analysed
    19
    19
    Units: mean DR (%)
    number (not applicable)
        Liver
    95.9
    66.4
        Bone
    97.0
    41.7
        Lymph nodes
    99.8
    71.4
        Lung
    100.0
    75.0
        Peritoneum
    99.5
    70.0
        Pancreas
    100.0
    83.3
        Pleura
    100.0
    0.0
        Small intestine
    80.0
    80.0
        Soft tissue
    100.0
    100.0
        Muscle
    100.0
    100.0
        Heart
    100.0
    100.0
        All
    96.4
    69.1
    Statistical analysis title
    		 Comparison DR Liver lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTANOC (part A)
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [16]
    P-value
    		 = 0.002
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [16] - 16 patients had liver lesions
    Statistical analysis title
    		 Comparison DR Bone lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTANOC (part A)
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [17]
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [17] - 11 patients had bone lesions
    Statistical analysis title
    		 Comparison DR Lymph node lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTANOC (part A)
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [18]
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [18] - 16 patients had lymph node lesions
    Statistical analysis title
    		 Comparison DR Lung lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTANOC (part A)
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [19]
    P-value
    		 = 0.32
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [19] - 4 patients had lung lesions
    Statistical analysis title
    		 Comparison DR Peritoneum lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTANOC (part A)
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [20]
    P-value
    		 = 0.11
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [20] - 4 patients had peritoneal lesions
    Statistical analysis title
    		 Comparison DR Pancreas lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTANOC (part A)
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [21]
    P-value
    		 = 0.32
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [21] - 3 patients had pancreas lesions
    Statistical analysis title
    		 Comparison DR All lesions
    Comparison groups
    Al18F-NOTA-octreotide (part A) v 68Ga-DOTANOC (part A)
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: DDR analysis according to tumor grade (part A)

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    End point title
    		 DDR analysis according to tumor grade (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 G1 (part A) G2 (part A)
    Number of subjects analysed
    35
    34
    Units: percent
        arithmetic mean (confidence interval 95%)
    14.9 (6.0 to 23.8)
    16.6 (6.3 to 27.0)
    No statistical analyses for this end point

    Secondary: DR analysis according to tumor grade (part A)

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    End point title
    		 DR analysis according to tumor grade (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: mean DR (%)
    number (not applicable)
        G1
    75.0
    89.9
        G2
    75.5
    92.1
        G3
    62.0
    97.4
    Statistical analysis title
    		 DR comparison G1 subgroup
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [22]
    P-value
    		 = 0.003
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [22] - n = 35
    Statistical analysis title
    		 DR comparison G2 subgroup
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [23]
    P-value
    		 = 0.002
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [23] - n = 34

    Secondary: Lesion uptake analysis in SUVmax (part A)

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    End point title
    		 Lesion uptake analysis in SUVmax (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: SUVmax
    arithmetic mean (standard deviation)
        Liver
    22.4 ± 11.4
    21.5 ± 12.4
        Bone
    11.4 ± 8.3
    8.6 ± 6.3
        Lymph nodes
    20.9 ± 14.3
    19.9 ± 16.9
        Lung
    24.8 ± 29.5
    16.9 ± 17.0
        Peritoneum
    16.3 ± 11.9
    14.9 ± 9.9
        Pancreas
    51.1 ± 38.6
    51.9 ± 45.6
        Pleura
    14.6 ± 0
    5.7 ± 0
        Small intestine
    20.7 ± 13.1
    24.2 ± 17.2
        Rectum
    16.8 ± 17.1
    21.4 ± 16.1
        Soft tissue
    6.9 ± 2.5
    7.3 ± 3.0
        Muscle
    4.4 ± 3.0
    4.2 ± 1.6
        Heart
    12.7 ± 10.5
    13.3 ± 11.4
        Breast
    6.8 ± 5.8
    9.5 ± 8.9
        Paraganglia
    58.9 ± 0
    35.6 ± 0
        Max. 20 per patient
    27.7 ± 16.9
    24.7 ± 16.3
        Max. 5 per organ
    28.9 ± 17.9
    25.3 ± 16.2
        All
    22.4 ± 15.6
    20.0 ± 14.5
    Statistical analysis title
    		 Comparison SUVmax Liver
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.76
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax Bone
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax Lymph nodes
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.19
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax Lung
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.088
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax Peritoneum
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.87
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax Pancreas
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.94
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax Max. 20 per patient
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.036
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax Max. 5 per organ
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.032
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax All
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.067
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Lesion uptake analysis in TBR (part A)

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    End point title
    		 Lesion uptake analysis in TBR (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: TBR
    arithmetic mean (standard deviation)
        Liver
    4.8 ± 3.8
    6.7 ± 5.2
        Bone
    10.1 ± 7.3
    13.8 ± 9.9
        Lymph nodes
    36.5 ± 24.2
    49.9 ± 40.8
        Lung
    44.0 ± 61.2
    42.7 ± 50.4
        Peritoneum
    29.2 ± 24.4
    33.7 ± 25.6
        Pancreas
    90.3 ± 65.4
    141.1 ± 113.8
        Pleura
    29.8 ± 0
    14.6 ± 0
        Small intestine
    34.4 ± 15.8
    52.3 ± 29.3
        Rectum
    49.8 ± 61.5
    137.1 ± 162.3
        Soft tissue
    13.0 ± 4.0
    24.1 ± 11.8
        Muscle
    8.1 ± 5.6
    14.6 ± 9.6
        Heart
    23.0 ± 20.1
    32.1 ± 26.5
        Breast
    11.1 ± 6.4
    18.6 ± 12.8
        Paraganglia
    83.0 ± 0
    77.3 ± 0
        Max. 20 per patient
    29.2 ± 33.1
    37.6 ± 40.0
        Max. 5 per organ
    33.0 ± 33.1
    42.3 ± 40.0
        All
    25.1 ± 32.7
    31.7 ± 36.5
    Statistical analysis title
    		 Comparison TBR Liver
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR Bone
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR Lymph nodes
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR Lung
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.95
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR Peritoneum
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.091
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR Pancreas
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.006
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR Max. 20 per patient
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR Max. 5 per organ
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.002
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR All
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Lesion uptake in SUVmax according to routine 68Ga-DOTA-SSA tracer (part A)

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    End point title
    		 Lesion uptake in SUVmax according to routine 68Ga-DOTA-SSA tracer (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: SUVmax
    arithmetic mean (standard deviation)
        68Ga-DOTATATE
    23.3 ± 16.9
    19.0 ± 14.8
        68Ga-DOTANOC
    19.6 ± 11.2
    23.1 ± 13.7
    Statistical analysis title
    		 Comparison SUVmax 68Ga-DOTATATE
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.002
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax 68Ga-DOTANOC
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Lesion uptake in TBR according to routine 68Ga-DOTA-SSA tracer (part A)

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    End point title
    		 Lesion uptake in TBR according to routine 68Ga-DOTA-SSA tracer (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: TBR
    arithmetic mean (standard deviation)
        68Ga-DOTATATE
    26.6 ± 36.4
    31.8 ± 38.9
        68Ga-DOTANOC
    20.7 ± 17.7
    31.2 ± 29.2
    Statistical analysis title
    		 Comparison TBR 68Ga-DOTATATE
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.12
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR 68Ga-DOTANOC
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Lesion uptake in SUVmax according to tumor grade (part A)

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    End point title
    		 Lesion uptake in SUVmax according to tumor grade (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: SUVmax
    arithmetic mean (standard deviation)
        G1
    22.9 ± 16.8
    17.9 ± 11.5
        G2
    22.1 ± 14.5
    22.4 ± 17.7
        G3
    15.2 ± 4.2
    19.0 ± 0.6
    Statistical analysis title
    		 Comparison SUVmax G1
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax G2
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Lesion uptake in TBR according to tumor grade (part A)

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    End point title
    		 Lesion uptake in TBR according to tumor grade (part A)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: TBR
    arithmetic mean (standard deviation)
        G1
    26.7 ± 41.4
    27.9 ± 36.1
        G2
    23.3 ± 22.5
    35.8 ± 39.2
        G3
    10.3 ± 9.5
    15.3 ± 8.7
    Statistical analysis title
    		 Comparison TBR G1
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR G2
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.003
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: TNM staging based on both [Ga68]-DOTATATE/-NOC and [18F]AlF-NOTA-octreotide images

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    End point title
    		 TNM staging based on both [Ga68]-DOTATATE/-NOC and [18F]AlF-NOTA-octreotide images
    End point description
    TNM staging based on both [Ga68]-DOTATATE/-NOC and [18F]AlF-NOTA-octreotide images of all study patients from arm A
    End point type
    Secondary
    End point timeframe
    Overall study duration
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    75
    75
    Units: number of patients
        T0N0M1a
    4
    3
        T0N0M1b
    1
    2
        T0N0M1c
    4
    3
        T0N1M0
    1
    1
        T0N1M1a
    5
    5
        T0N1M1b
    3
    3
        T0N1M1c
    18
    19
        T0N2M1b
    2
    2
        T0N2M1c
    5
    5
        T1cN0M0
    1
    1
        T1N0M0
    1
    1
        T1N1M1a
    1
    0
        T1N1M1c
    2
    3
        T2N0M0
    1
    1
        T2N0M1a
    2
    2
        T2N1M0
    2
    2
        T2N1M1a
    3
    2
        T2N1M1b
    2
    2
        T2N1M1c
    9
    9
        T2N2M1c
    0
    2
        T3N1M0
    1
    1
        T3N1M1a
    1
    1
        T3N1M1c
    3
    3
        T3N2M1b
    1
    1
        T4N2M1b
    1
    1
        T2N2M1b
    1
    0
    No statistical analyses for this end point

    Secondary: Differences in TNM staging based on both Ga68-DOTATATE/-NOC and [18F]AlF-NOTA-octreotide images

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    End point title
    		 Differences in TNM staging based on both Ga68-DOTATATE/-NOC and [18F]AlF-NOTA-octreotide images [24]
    End point description
    To assess differences in TNM staging based on both 68Ga-DOTATATE/-NOC and AlF-NOTA-octreotide PET images. Upstaging = higher TNM stage based on AlF-NOTA-oc images Downstaging = lower TNM stage based on AlF-NOTA-oc images
    End point type
    Secondary
    End point timeframe
    Overall study timeline
    Notes
    [24] - 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: No statistical analysis needed, number of patients with a difference in TNM staging
    End point values
    		 PET/CT (Part A)
    Number of subjects analysed
    75
    Units: Number of cases
        Total differences in TNM
    10
        Upstaging
    7
        Downstaging
    3
    No statistical analyses for this end point

    Secondary: Differences in clinical management when using [18F]AlF-NOTA-octreotide

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    End point title
    		 Differences in clinical management when using [18F]AlF-NOTA-octreotide [25]
    End point description
    To assess differences in clinical management based on both PET tracers. For each patient, the images from the SSTR PET ([68Ga]Ga-DOTA-SSA or [18F]AlF-OC; in random order and with the experts blinded to the exact tracer used), were presented at a multidisciplinary tumor board-like setting and a final consensus decision for patient management will be recorded. Subsequently, they will be presented with the PET images from the other tracer and asked if they want to change their decision based on the new images. Minor change = intramodality change Major change = intermodality change
    End point type
    Secondary
    End point timeframe
    Overall study timeline
    Notes
    [25] - 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: No statistical analysis needed, number of patients with a therapy change based on AlF-NOTA-octreotide
    End point values
    		 PET/CT (Part A)
    Number of subjects analysed
    75
    Units: Number of cases with management change
        Total changes in management
    10
        Therapy upgrade
    10
        Therapy downgrade
    0
        Minor change
    7
        Major change
    3
    No statistical analyses for this end point

    Post-hoc: DDR analysis according to primary (part A)

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    End point title
    		 DDR analysis according to primary (part A)
    End point description
    End point type
    Post-hoc
    End point timeframe
    End of study
    End point values
    		 Primary: intestine (part A) Primary: pancreas (part A)
    Number of subjects analysed
    45
    18
    Units: percent
        arithmetic mean (confidence interval 95%)
    17.8 (9.2 to 26.4)
    8.4 (-1.2 to 18.0)
    No statistical analyses for this end point

    Post-hoc: DR analysis according to primary (part A)

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    End point title
    		 DR analysis according to primary (part A)
    End point description
    End point type
    Post-hoc
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    63
    63
    Units: mean DR (%)
    number (not applicable)
        Intestine
    72.6
    90.4
        Pancreas
    84.2
    92.7
    Statistical analysis title
    		 DR comparison Intestinal primary subgroup
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    126
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [26]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [26] - n = 45
    Statistical analysis title
    		 DR comparison Pancreatic primary subgroup
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    126
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [27]
    P-value
    		 = 0.087
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [27] - n = 18

    Post-hoc: Lesion uptake in SUVmax according to primary (part A)

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    End point title
    		 Lesion uptake in SUVmax according to primary (part A)
    End point description
    End point type
    Post-hoc
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    63
    63
    Units: SUVmax
    arithmetic mean (standard deviation)
        Intestine
    17.8 ± 6.0
    16.3 ± 9.4
        Pancreas
    28.0 ± 16.7
    26.9 ± 19.9
    Statistical analysis title
    		 Comparison SUVmax Intestinal primary
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    126
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.18
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison SUVmax Pancreatic primary
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    126
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Post-hoc: Lesion uptake in TBR according to primary (part A)

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    End point title
    		 Lesion uptake in TBR according to primary (part A)
    End point description
    End point type
    Post-hoc
    End point timeframe
    End of study
    End point values
    		 68Ga-DOTATATE/NOC (part A) Al18F-NOTA-octreotide (part A)
    Number of subjects analysed
    63
    63
    Units: TBR
    arithmetic mean (standard deviation)
        Intestine
    17.8 ± 13.0
    22.6 ± 20.2
        Pancreas
    26.3 ± 26.6
    40.7 ± 43.9
    Statistical analysis title
    		 Comparison TBR Intestinal primary
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    126
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Comparison TBR Pancreatic primary
    Comparison groups
    68Ga-DOTATATE/NOC (part A) v Al18F-NOTA-octreotide (part A)
    Number of subjects included in analysis
    126
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.043
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    until discharge from the hospital after the study scan
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 85 (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
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 85 (25.88%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    22 / 85 (25.88%)
         occurrences all number
    22

    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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