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    Clinical Trial Results:
    18F-MFBG PET imaging of the norepinephrine transporter in neural crest and neuroendocrine tumors: a phase I PET/CT study

    Summary
    EudraCT number
    		 2019-003872-37
    Trial protocol
    		 BE  
    Global end of trial date
    13 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    S63142
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04258592
    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
    15 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluate the potential of 18F-MFBG as a PET hNET imaging agent in patients with neural crest and neuroendocrine tumors
    Protection of trial subjects
    Adult female participants of childbearing potential must agree to use highly effective medically accepted contraceptive methods to prevent pregnancy. Minor female participants of childbearing potential that are sexually active, may only participate if they already use highly effective contraceptive methods. A serum and urinary hCG test is performed prior to 18F-MFBG administration. Male participants should refrain from sexual activity for 90 days after injection, or otherwise use a condom to prevent pregnancy, except for vasectomized. Sperm donation or preservation is also prohibited during this 90-day interval.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    07 Feb 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: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    1
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were either contacted at the time when they were scheduled for 123I-MIBG imaging or they were recruited by members of the study team during their contact with the patient.

    Pre-assignment
    Screening details
    		 Patients, aged 1 year or older, with neural crest tumors (or neuroendocrine tumors) with routine clinical 123I-MIBG imaging (planar + SPECT) performed in the previous six months or scheduled within three months were enrolled.

    Pre-assignment period milestones
    Number of subjects started
    		 7 [1]
    Number of subjects completed
    		 6

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One patient underwent a screening visit, but withdrew consent before the actual inclusion visit and was therefore not enrolled in the trial, as defined in the study protocol.
    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
    Arm title
    		 Patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]MFBG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 MBq/kg (adult participants); 2 MBq/kg (minor participants) 1 day, single dose no treatment: diagnostic scanning

    Number of subjects in period 1
    		Patients
    Started
    6
    Completed
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 Neural crest tumor patients with a routine clinical 123I-MIBG imaging scintigraphy performed within 6 months prior to inclusion or scheduled within 3 months after inclusion.

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 1 1
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Patients
    Reporting group description
    		 -

    Subject analysis set title
    123I-MIBG
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Routine clinical 123I-MIBG scintigraphy

    Subject analysis set title
    18F-MFBG 1h p.i.
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    18F-MFBG study PET scan at 1 hour post-injection (p.i.)

    Subject analysis set title
    18F-MFBG 2h p.i.
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    18F-MFBG study PET scan at 2 hour post-injection (p.i.)

    Subject analysis set title
    18F-MFBG 3h p.i.
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    18F-MFBG study PET scan at 3 hour post-injection (p.i.)

    Subject analysis set title
    Adult patients
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Adult patients with dynamic 18F-MFBG study PET scan

    Subject analysis set title
    Phaeochromocytoma patients
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Adult phaeochromocytoma patients with dynamic 18F-MFBG study PET scan

    Primary: Primary: Lesion detection rate

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    End point title
    		 Primary: Lesion detection rate
    End point description
    End point type
    Primary
    End point timeframe
    End of study
    End point values
    		 123I-MIBG 18F-MFBG 1h p.i. 18F-MFBG 2h p.i. 18F-MFBG 3h p.i.
    Number of subjects analysed
    6
    6
    5
    5
    Units: Detection rate (%)
    number (not applicable)
        Patient 1
    33.8
    98.7
    98.7
    89.6
        Patient 2
    86.7
    100.0
    100.0
    100.0
        Patient 3
    100.0
    100.0
    100.0
    100.0
        Patient 4
    57.4
    100.0
    .0
    .0
        Patient 5
    50.0
    100.0
    75.0
    75.0
        Patient 6
    38.2
    100.0
    100.0
    100.0
    Statistical analysis title
    		 Lesion detection rate comparison
    Comparison groups
    123I-MIBG v 18F-MFBG 1h p.i.
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.043
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pharmacokinetics

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    End point title
    		 Pharmacokinetics
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 Adult patients Phaeochromocytoma patients
    Number of subjects analysed
    5
    4
    Units: VT(ml/cm³)
        median (full range (min-max))
    29.0 (8.4 to 144.8)
    37.4 (18.0 to 144.8)
    Attachments
    		 Untitled (Filename: Pharmacokinetics.jpg)
    No statistical analyses for this end point

    Secondary: Normal organ uptake (as a function of time)

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    End point title
    		 Normal organ uptake (as a function of time)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 123I-MIBG 18F-MFBG 1h p.i. 18F-MFBG 2h p.i. 18F-MFBG 3h p.i.
    Number of subjects analysed
    4
    4
    3
    3
    Units: SUVmean
    arithmetic mean (standard deviation)
        Salivary glands
    2.42 ± .0
    9.19 ± 3.38
    8.38 ± 4.39
    8.31 ± 4.72
        Liver (left lobe)
    3.01 ± 1.02
    6.59 ± 2.14
    4.94 ± 2.78
    4.05 ± 2.16
        Liver (right lobe)
    1.87 ± 0.89
    4.22 ± 1.67
    2.96 ± 1.47
    2.47 ± 1.13
        Thyroid
    2.52 ± .0
    6.56 ± 1.89
    5.29 ± 0.74
    5.07 ± 0.60
        Adrenals
    2.77 ± 1.38
    4.32 ± 2.28
    4.18 ± 3.05
    4.53 ± 3.58
        Left ventricle wall
    2.22 ± 1.42
    6.60 ± 4.15
    4.72 ± 3.89
    4.04 ± 3.35
        Kidneys
    0.74 ± 0.29
    2.27 ± 0.75
    1.52 ± 0.29
    1.22 ± 0.47
        Pancreas
    1.12 ± 0.85
    2.91 ± 2.06
    1.70 ± 1.57
    1.29 ± 1.15
        Bowel
    1.02 ± 0.50
    2.40 ± 0.86
    1.78 ± 0.83
    1.55 ± 0.75
        Spleen
    1.09 ± 0.86
    1.33 ± 0.61
    1.23 ± 0.73
    1.14 ± 0.85
        Muscle
    0.52 ± 0.12
    0.66 ± 0.36
    0.94 ± 0.09
    0.98 ± 0.15
        Bone
    0.31 ± 0.10
    0.65 ± 0.21
    0.60 ± 0.22
    0.63 ± 0.19
        Bloodpool
    0.23 ± 0.10
    0.43 ± 0.11
    0.36 ± 0.10
    0.34 ± 0.14
    No statistical analyses for this end point

    Secondary: 18F-MFBG lesion SUVmax as a function of time (lesion targeting and ideal time point identification)

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    End point title
    		 18F-MFBG lesion SUVmax as a function of time (lesion targeting and ideal time point identification)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 18F-MFBG 1h p.i. 18F-MFBG 2h p.i. 18F-MFBG 3h p.i.
    Number of subjects analysed
    5
    5
    5
    Units: SUVmax
    arithmetic mean (standard deviation)
        Bone lesions
    9.1 ± 0.9
    8.2 ± 2.2
    7.7 ± 2.8
        Lymph nodes
    15.4 ± 9.1
    14.6 ± 8.5
    14.8 ± 9.8
        Other lesions
    15.8 ± 13.4
    17.3 ± 16.0
    18.0 ± 17.3
        All lesions
    19.3 ± 10.7
    20.8 ± 13.4
    21.7 ± 14.8
    Statistical analysis title
    		 Comparison of SUVmax of all lesions between scans
    Comparison groups
    18F-MFBG 1h p.i. v 18F-MFBG 2h p.i.
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.34
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Comparison of SUVmax of all lesions between scans
    Comparison groups
    18F-MFBG 1h p.i. v 18F-MFBG 3h p.i.
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.34
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Comparison of SUVmax of all lesions between scans
    Comparison groups
    18F-MFBG 3h p.i. v 18F-MFBG 2h p.i.
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.34
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: 18F-MFBG lesion TBR as a function of time (lesion targeting and ideal time point identification)

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    End point title
    		 18F-MFBG lesion TBR as a function of time (lesion targeting and ideal time point identification)
    End point description
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 18F-MFBG 1h p.i. 18F-MFBG 2h p.i. 18F-MFBG 3h p.i.
    Number of subjects analysed
    5
    5
    5
    Units: TBR (tumor-to-background ratio)
    arithmetic mean (standard deviation)
        Bone lesions
    21.1 ± 1.4
    20.7 ± 7.1
    17.9 ± 7.1
        Lymph nodes
    17.1 ± 9.4
    16.8 ± 8.6
    18.4 ± 11.3
        Other lesions
    16.8 ± 14.1
    17.1 ± 14.8
    17.6 ± 14.8
        All lesions
    23.6 ± 8.4
    24.6 ± 8.5
    24.5 ± 9.0
    Statistical analysis title
    		 Comparison of TBR of all lesions between scans
    Comparison groups
    18F-MFBG 1h p.i. v 18F-MFBG 2h p.i.
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.52
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Comparison of TBR of all lesions between scans
    Comparison groups
    18F-MFBG 1h p.i. v 18F-MFBG 3h p.i.
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.69
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Comparison of TBR of all lesions between scans
    Comparison groups
    18F-MFBG 3h p.i. v 18F-MFBG 2h p.i.
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.98
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Comparison of lesion SUVmax with 18F-MFBG and 123I-MIBG (lesion targeting)

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    End point title
    		 Comparison of lesion SUVmax with 18F-MFBG and 123I-MIBG (lesion targeting)
    End point description
    For patients in whom a quantitative SPECT was obtained
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 123I-MIBG 18F-MFBG 1h p.i.
    Number of subjects analysed
    4
    4
    Units: SUVmax
        arithmetic mean (standard deviation)
    15.8 ± 13.2
    22.1 ± 18.2
    Statistical analysis title
    		 Comparison of lesion SUVmax between tracers
    Comparison groups
    123I-MIBG v 18F-MFBG 1h p.i.
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.37
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Comparison of lesion TBR with 18F-MFBG and 123I-MIBG (lesion targeting)

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    End point title
    		 Comparison of lesion TBR with 18F-MFBG and 123I-MIBG (lesion targeting)
    End point description
    For all patients
    End point type
    Secondary
    End point timeframe
    End of study
    End point values
    		 123I-MIBG 18F-MFBG 1h p.i.
    Number of subjects analysed
    6
    6
    Units: TBR (tumor-ro-background ratio)
        arithmetic mean (standard deviation)
    23.7 ± 15.7
    27.2 ± 11.3
    Statistical analysis title
    		 Comparison of lesion TBR between tracers
    Comparison groups
    123I-MIBG v 18F-MFBG 1h p.i.
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.44
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until last telephone follow-up interview of the subject
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Patients
    Reporting group description
    		 -

    Serious adverse events
    		 Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (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
    		 Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    Investigations
    Neutrophil count decreased
    Additional description: Grade 1
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Grade 1
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
    Additional description: Grade 1
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypocalcaemia
    Additional description: Grade 1
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Hyponatraemia
    Additional description: Grade 1
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Hyperkalaemia
    Additional description: Grade 1
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2020
    The age of the population to be studied was changed from 18 years to 1 year or older and some flexibility was introduced in the imaging protocol for minor participants only to increase the feasibility for these patients. For adult participants the substantial amendment did not imply any changes to the study procedures.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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