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    Clinical Trial Results:
    MET-PET-study - Comparative study of Tc-99m- sestamibi SPECT/ldCT with C-11-L-Methionin PET/diagnostic CT and theri ability to locate paratyroid adenomas preoperatively.

    Summary
    EudraCT number
    		 2013-004886-14
    Trial protocol
    		 DK  
    Global end of trial date
    13 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2023
    First version publication date
    01 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2013092981
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dep. Nuclear medicine, Odense univeristy hospital
    Sponsor organisation address
    Kløvervænget 17, Odense, Denmark, 5000
    Public contact
    sys.vestergaard@rsyd.dk, Dep.nuclear medicine, Odense university hospital, 45 65412980, sys.vestergaard@rsyd.dk
    Scientific contact
    sys.vestergaard@rsyd.dk, Dep.nuclear medicine, Odense university hospital, 45 65412980, sys.vestergaard@rsyd.dk
    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
    06 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    MET-PET-study - Comparative study of Tc-99m- sestamibi SPECT/ldCT with C-11-L-Methionine PET/diagnostic CT and their ability to locate hyerpunctioning paratyroid tissue preoperatively in suspected primary hyperparathyroidism.
    Protection of trial subjects
    Routine care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Apr 2016
    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
    Denmark: 27
    Worldwide total number of subjects
    27
    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)
    19
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 adult patients diagnosed with primary hyperparathyroidism referred to preoperative localization of potential hyperfunctioning parathyroid tissue.

    Pre-assignment
    Screening details
    		 Patients diagnosed with primary hyperparathyroidism referred to surgical removal of hyperfunctioning parathyroid tissue

    Period 1
    Period 1 title
    Technetium 99m Sestamibi
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Sestamibi
    Arm description
    		 Conventionel parathyroid scintigraphy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TECHNETIUM (99MTC) SESTAMIBI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Up to 700 MBq megabecquerel(s)

    Number of subjects in period 1
    		Sestamibi
    Started
    27
    Completed
    27
    Period 2
    Period 2 title
    C-11-Methionine
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Methionin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    C-11-L-Methionin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    420 to 560 MBq megabecquerel(s)

    Number of subjects in period 2
    		Methionin
    Started
    27
    Completed
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sestamibi
    Reporting group description
    		 Conventionel parathyroid scintigraphy

    Reporting group values
    		 Sestamibi Total
    Number of subjects
    		 27 27
    Age categorical
    > Men and women over the age of 18 yr
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 19 19
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Gender categorical
    Men and women
    Units: Subjects
        Female
    		 18 18
        Male
    		 9 9
    Subject analysis sets

    Subject analysis set title
    localisation of adenoma
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients refered to surgical treatment of primary hyperparathyroidism refered to preoperative localization having performed both our conventionel parathyroid scintigraphy and Methionin PET/CT.

    Subject analysis sets values
    		 localisation of adenoma
    Number of subjects
    27
    Age categorical
    > Men and women over the age of 18 yr
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    19
        From 65-84 years
    8
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Men and women
    Units: Subjects
        Female
    19
        Male
    8

    End points

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    End points reporting groups
    Reporting group title
    Sestamibi
    Reporting group description
    		 Conventionel parathyroid scintigraphy
    Reporting group title
    Methionin
    Reporting group description
    		 -

    Subject analysis set title
    localisation of adenoma
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients refered to surgical treatment of primary hyperparathyroidism refered to preoperative localization having performed both our conventionel parathyroid scintigraphy and Methionin PET/CT.

    Primary: Primary endpoints

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    End point title
    		 Primary endpoints
    End point description
    Detection of adenomas in each of the two scanningmodalities performed in each patient, compared to the peroperative findings including histopatologic findings and verified with postoperative bloodsample controls.
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Sestamibi Methionin localisation of adenoma
    Number of subjects analysed
    27
    27
    27
    Units: hyperplastic parathyroid tissue
        adenoma
    19
    19
    19
        hyperplastic tissue
    8
    8
    8
    Statistical analysis title
    		 Comparable
    Statistical analysis description
    Identification of adenomas and/or hyperplasia versus normal histology was analyzed on a per-lesion basis by sensitivity, specificity, PPV, NPV and accuracy.
    Comparison groups
    Sestamibi v Methionin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.24
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.091837

    Secondary: Secondary end points

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    End point title
    		 Secondary end points
    End point description
    The ability of the two imaging modalities to correctly localize the hyperfuntioning parathyroid tissue on a phantomdrawing of the thyroid divided into 3 sites on each side, one at istmus and 3 sites for ectopic localization at caput, collum or thorax and lastly the opportunity of nothing localized. The certainty of detection or no detection on a likert scale from 1-5.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 localisation of adenoma
    Number of subjects analysed
    Units: Likert
    number (not applicable)
        Likert
    27
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    May 4 2016 - March 21 2020
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    27 patients
    Reporting group description
    		 Out of 27 patients having two imaging examinations perfomed, only one patient developed one incidence of urticaria due to physical pressure on the tissue, to which the patient was known to prior to inclusion.

    Serious adverse events
    		 27 patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.04%
    Non-serious adverse events
    		 27 patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Skin and subcutaneous tissue disorders
    Urticaria pressure
    Additional description: Known condition.
         subjects affected / exposed
    1 / 1 (100.00%)
         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
    03 Mar 2017
    Due to lack of operation tables, the time from completed last scan to completed operation was increased from 2 month to 12 month.

    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.
    Due to the long inclusionfase, it was difficult to obtain skills assessing the non-conventional imaging scans which can have been a drawback compared to the conventional modality.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36881250
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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