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    Clinical Trial Results:
    Patterns of uptake of 18F-FDG and 68Ga-DOTA PET in advanced neuroendocrine tumors

    Summary
    EudraCT number
    		 2018-000398-64
    Trial protocol
    		 ES  
    Global end of trial date
    02 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2022
    First version publication date
    04 Jun 2022
    Other versions
    Summary report(s)
    		 DOTATOC Final study report

    Trial information

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    Trial identification
    Sponsor protocol code
    VHIO18001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIO
    Sponsor organisation address
    Carrer de Natzaret, 117, 08035 Barcelona, España, Barcelona, Spain, 08035
    Public contact
    Clinical Research Support Unit, Vall d' Hebron Institute of Oncology (VHIO), 34 932 543 4508614, smunoz@vhio.net
    Scientific contact
    Clinical Research Support Unit, Vall d' Hebron Institute of Oncology (VHIO), 605925779 932 543 4508614, smunoz@vhio.net
    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
    04 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1-To determine the sensitivity of 68Ga-DOTA PET-CT to detect tumors with high expression of RSST as compared to that of standard of care with octreotide labeled with gamma-emitting radionuclides 2- To identify the uptake patterns of 18F-FDG and 68Ga-DOTA PET-CT within subjects with well or moderately differentiated metastatic GEP-NET (ENETS grades 1 and 2). 3-To establish the correlation between the functional characteristics of hepatic lesions and the level of uptake of 18F-FDG and 68Ga. 4-To explore the impact of this combined imaging test on therapeutics.
    Protection of trial subjects
    Two days after injection of the radiotracer 68Ga-DOTATOC, a follow-up phone call was carried out to ask for and assess any experienced adverse events. No immediate adverse reaction related to radiotracer injection was reported and the subjects reported no adverse events from the time of radioisotope injection until two days after the imaging probe.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 2018
    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
    Spain: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    22
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were diagnosed using a routine diagnostic algorithm. This includes routine imaging tests (CT, MRI, PET-FDG) to locate and characterize the primary tumor as well as a scintigraphy with receptors of the somatostatin to determine the affinity of the tumor to the analogs. The oncologist recruited the patients and perform a clinic visit.

    Pre-assignment
    Screening details
    		 The study population were composed of 30 patients with metastatic NET. Inclusion criteria: 1. Patients older than 18 years. 2. Grade 1 and 2 NETs according to WHO and ENETS classification. 3. Metastatic NETs. 4. Life expectancy > 12 months. 5. Signed written informed consent

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

    Arms
    Arm title
    		 Complete Set
    Arm description
    		 In this study there is only 1 arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    SomaKit TOC (edotreotide or DOTATOC)
    Investigational medicinal product code
    SUB183602
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection. The activity will be adapted to the characteristics of the patient, the type of PET camera used and the mode of acquisition. The Reaction Buffer vial contains approximately 32.5 mg of sodium.

    Number of subjects in period 1
    		Complete Set
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 22 22
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
        Adults
    		 0 0
        Older
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 58.1 (36 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Complete Set
    Reporting group description
    		 In this study there is only 1 arm

    Subject analysis set title
    68Ga-DOTATOC PET/CT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients undergoing 68Ga-DOTATOC PET/CT

    Subject analysis set title
    99mTc-Tektrotyd SPECT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients undergoing 99mTc-Tektrotyd SPECT

    Subject analysis set title
    18F-FDG PET/CT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients undergoing 18F-FDG PET/CT

    Primary: Sensitivity of 68Ga-DOTATOC PET/CT vs 99mTc-Tektrotyd SPECT

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    End point title
    		 Sensitivity of 68Ga-DOTATOC PET/CT vs 99mTc-Tektrotyd SPECT
    End point description
    The performance of both imaging methods was analyzed and compared for the detection of primary tumor, loco-regional tumor (N1) and global tumor lesions (M1). A region was regarded positive if at least 1 lesion was detected in that region. Additionally, number of detected lesions were also compared between both methods according to the location and involved organs as follows: 1) liver, 2) lung, 3) bone, 4) nodal infra, 5) nodal supra and 6) soft tissues of the body.
    End point type
    Primary
    End point timeframe
    This endpoint was evaluated after having performed both tests in each of the patients included in the trial
    End point values
    		 68Ga-DOTATOC PET/CT 99mTc-Tektrotyd SPECT
    Number of subjects analysed
    30
    30
    Units: Sensitivity (%)
    number (not applicable)
        Primary tumour
    39.3
    39.3
        Loco-regional tumour (N1)
    63.3
    43.3
        Global tumour lesions (M1)
    100
    90
    Attachments
    		 Sensitivity (number of lesions)
    Statistical analysis title
    		 Sensitivity in the detection of primary tumour
    Statistical analysis description
    Differences in diagnostic performance (sensitivity) between the PET/CT and SPECT results were tested for significance using McNemar’s test (two level of significance <0.05).
    Comparison groups
    99mTc-Tektrotyd SPECT v 68Ga-DOTATOC PET/CT
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Mcnemar
    Confidence interval
    Statistical analysis title
    		 Sensitivity in loco-regional tumour (N1)
    Statistical analysis description
    Differences in diagnostic performance (sensitivity) between the PET/CT and SPECT results were tested for significance using McNemar’s test (two level of significance <0.05).
    Comparison groups
    68Ga-DOTATOC PET/CT v 99mTc-Tektrotyd SPECT
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 Mcnemar
    Confidence interval
    Statistical analysis title
    		 Sensitivity in global tumour lesions (M1)
    Statistical analysis description
    Differences in diagnostic performance (sensitivity) between the PET/CT and SPECT results were tested for significance using McNemar’s test (two level of significance <0.05).
    Comparison groups
    99mTc-Tektrotyd SPECT v 68Ga-DOTATOC PET/CT
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.083
    Method
    		 Mcnemar
    Confidence interval

    Primary: Sensitivity of 68Ga-DOTATOC PET/CT vs 18F-FDG PET/CT

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    End point title
    		 Sensitivity of 68Ga-DOTATOC PET/CT vs 18F-FDG PET/CT
    End point description
    The performance of both imaging methods was analyzed and compared for the detection of primary tumor, loco-regional tumor (N1) and global tumor lesions (M1). A region was regarded positive if at least 1 lesion was detected in that region. Additionally, number of detected lesions were also compared between both methods according to the location and involved organs as follows: 1) liver, 2) lung, 3) bone, 4) nodal infra, 5) nodal supra and 6) soft tissues of the body.
    End point type
    Primary
    End point timeframe
    This endpoint was evaluated after having performed both tests in each of the patients included in the trial.
    End point values
    		 68Ga-DOTATOC PET/CT 18F-FDG PET/CT
    Number of subjects analysed
    30
    30
    Units: Sensitivity (%)
    number (not applicable)
        Primary tumour
    37.9
    31.0
        Loco-regional tumor (N1)
    63.3
    31.6
        Global tumour (M1)
    100
    66.7
    Attachments
    		 Sensitivity (number of lesions)
    Statistical analysis title
    		 Sensitivity in primary tumour
    Statistical analysis description
    Differences in diagnostic performance (sensitivity) between the PET/CT and SPECT results were tested for significance using McNemar’s test (two level of significance <0.05).
    Comparison groups
    68Ga-DOTATOC PET/CT v 18F-FDG PET/CT
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.317
    Method
    		 Mcnemar
    Confidence interval
    Statistical analysis title
    		 Sensitivity in loco-regional tumour (N1)
    Statistical analysis description
    Differences in diagnostic performance (sensitivity) between the PET/CT and SPECT results were tested for significance using McNemar’s test (two level of significance <0.05).
    Comparison groups
    68Ga-DOTATOC PET/CT v 18F-FDG PET/CT
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mcnemar
    Confidence interval
    Statistical analysis title
    		 Sensitivity in global tumour (M1)
    Statistical analysis description
    Differences in diagnostic performance (sensitivity) between the PET/CT and SPECT results were tested for significance using McNemar’s test (two level of significance <0.05).
    Comparison groups
    68Ga-DOTATOC PET/CT v 18F-FDG PET/CT
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mcnemar
    Confidence interval

    Secondary: Change in therapeutic decision

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    End point title
    		 Change in therapeutic decision
    End point description
    The impact of additional data provided by 68Ga-DOTATOC PET/CT on the patient’s management was assessed.
    End point type
    Secondary
    End point timeframe
    This endpoint was evaluated after having performed study tests in each of the patients included in the trial.
    End point values
    		 Complete Set
    Number of subjects analysed
    30
    Units: Percentage
        number (not applicable)
    67.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All patients were followed for safety two days after the 68Ga-DOTATOC PET/CT scan was performed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Safety analysis set
    Reporting group description
    		 The safety analysis set was defined as all patients who underwent 68Ga -DOTATOC PET/CT.

    Serious adverse events
    		 Safety analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no serious adverse events reported in this study

    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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