Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    [18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease.

    Summary
    EudraCT number
    		 2015-003045-26
    Trial protocol
    		 SE  
    Global end of trial date
    11 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jun 2021
    First version publication date
    03 Jun 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Pearl-PD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Umeå University Hospital, Umeå Sweden
    Sponsor organisation address
    NA, umeå, Sweden, 901 85
    Public contact
    Susanna Jakobson Mo, Dept of Radiology, Umeå University Hospital, Umeå Sweden, 46 90785 31 79, susanna.jakobson.mo@umu.se
    Scientific contact
    Susanna Jakobson Mo, Umeå University Hospital, Umeå Sweden/Dept. of Radiation Sciences, Umeå University, Umeå Sweden, 46 90785 31 79, susanna.jakobson.mo@umu.se
    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
    11 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the diagnostic potential of [18F] FE PE2I PET in early stage untreated parkinsonian disease To "head-to-head" compare the diagnostic accuracy of the index test (with [18F] FE PE2I PET / CT) with the reference test (123I-FP-Cit, DaTSCAN ™ SPECT/CT) in newly onset idiopathic parkinsonism
    Protection of trial subjects
    All participants in the study gave their written and oral informed consent prior to inclusion. All imaging procedures were conducted by healthcare professionals at the hospital, and except for imaging with the index radiopharmaceuticval, all imaging procedures were conducted according to clinical routine practices. This study was approved my the regional Ethics Committee and the local radiation safety committee and the Swedish Medical Products Agency. Patients participating in this study were otherwise treated and followed up according to clinical routine. Collected data was pseudoized before statistical analysis.
    Background therapy
    		 All patients and healthy subjects did a brain MRI.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 77
    Worldwide total number of subjects
    77
    EEA total number of subjects
    77
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    15
    From 65 to 84 years
    62
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study patients were recruited consecutively at first admission to the dept. of Neurology at Umeå University Hospital for newly onset idiopathic parkinsonism. Healthy controls were recruited via announcements in the local newspaper.

    Pre-assignment
    Screening details
    		 A first screening of patients' eligibility according to inclusion and exclusion criteria were made from the letter of referral, then a second screening was done by neurological assessment. Healthy controls were interviewed briefly by a phone call and if eligible, were then invited and asessed physically by a neurologist.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study is single-blind, as for image data analysis and evaluation takes place without knowledge of the study participant's clinical diagnosis or clinical condition or results of other imaging diagnostics or laboratory diagnostics.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patients
    Arm description
    		 Patients with recent onset of idiopathic parkinsonism
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F] FE PE2I PET
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 MBq at weight 70 kg (2.86 MBq / kg). If the weight is less than 70 kg, the dose is reduced in proportion to the weight.

    Arm title
    		 Healthy controls
    Arm description
    		 Reference group
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F] FE PE2I PET
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 MBq at weight 70 kg (2.86 MBq / kg). If the weight is less than 70 kg, the dose is reduced in proportion to the weight.

    Investigational medicinal product name
    DaTSCAN™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    185 MBq which gives an effective radiation dose of 4.4 mSv

    Arm title
    		 Healty control dosimetry
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F] FE PE2I PET
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 MBq at weight 70 kg (2.86 MBq / kg). If the weight is less than 70 kg, the dose is reduced in proportion to the weight.

    Number of subjects in period 1
    		Patients Healthy controls Healty control dosimetry
    Started
    35
    37
    5
    Completed
    32
    36
    5
    Not completed
    3
    1
    0
         Consent withdrawn by subject
    1
    1
    -
         Procedure complication before study drug
    1
    -
    -
         Patient deceased due to cancer. Not AE in study.
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 77 77
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 62 62
    Gender categorical
    Units: Subjects
        Female
    		 35 35
        Male
    		 42 42

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Patients
    Reporting group description
    		 Patients with recent onset of idiopathic parkinsonism

    Reporting group title
    Healthy controls
    Reporting group description
    		 Reference group

    Reporting group title
    Healty control dosimetry
    Reporting group description
    		 -

    Primary: Sensitivity, specificity and predictive value of PET / CT with 18F FE PE2I in the striatum and extrastriatalt in the brain

    		 Close Top of page
    End point title
    		 Sensitivity, specificity and predictive value of PET / CT with 18F FE PE2I in the striatum and extrastriatalt in the brain [1]
    End point description
    -Sensitivity, specificity and predictive value of PET / CT with 18F FE PE2I in the striatum and extrastriatalt in the brain -Statistical difference in the sensitivity and specificity of PET / CT with 18F FE PE2I (Index test) compared to SPECT / CT imaging with 123I-FPCit (reference test)
    End point type
    Primary
    End point timeframe
    Two years after the imaging, when the clinical diagnosis is reassessed.
    Notes
    [1] - 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: Endpoint are not assessed for arm Dosimetry.
    End point values
    		 Patients Healthy controls
    Number of subjects analysed
    32
    30
    Units: Numbers
        number (not applicable)
    32
    30
    Statistical analysis title
    		 Statistical differences between groups
    Statistical analysis description
    Statistical differences between groups are analyzed by t-test and ANOVA or equivalent non-parametric tests depending on the type of data and group sizes. Relationship analyzes are performed with Pearson's correlation analysis or equivalent and regression models. Roc-analysis was used for calculation of predictive values.
    Comparison groups
    Patients v Healthy controls
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    2015-12-04--2018-07-02
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 74 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 74 (16.22%)
    Injury, poisoning and procedural complications
    Discomfort and neck pain lying on the hard bunk in the PET-camera
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    Passing palpitations after drug administration
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    Diffuse aching in the body caused by lying in the PET camera
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    Cold hands
    Additional description: Cold hands
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    Discomfort of mask
    Additional description: The moulded mask squeezed over face
         subjects affected / exposed
    2 / 74 (2.70%)
         occurrences all number
    2
    Passing numbness in right arm during scan
    Additional description: Passing numbness in right arm during scan
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    Pain in neck and occiput after scanning
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    General disorders and administration site conditions
    Passing pricking sensation in the temple and tearing eye
    Additional description: Passing pricking sensation in the temple and tearing eye
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    Sensation of tiredness and diffuse “haziness” during the day after scanning
    Additional description: Sensation of tiredness and diffuse “haziness” during the day after scanning
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    Cough
    Additional description: Fit of coughing during scan
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhea
    Additional description: Diarrhea the day after administration of 18F FE-PE2I. This was due to a known adverse reaction related to another medication
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2016
    1. Change of the number of included healthy controls from 20 to 30, permitting additional recruitment of healthy controls. 2. In the original protocol version, an interim analysis was planned for evaluation of the correlation between regional cerebral flow measured with dynamic 18F FE-PE2I-PET (index test) compared to the reference test with 15O H2O-PET only using data from the first included subjects. With the amendment, theprotocol stated that this analysis should be done including all participants after competion.
    11 Oct 2017
    1. Prolongation of the inclusion period with 12 months 2. Change of procedure for perfusion imaging with 15O H2O-PET 3. Adjustment in the text pertaining interim analyses, permitting reporting of scientifically important findings after finalizing the baseline imaging period

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29348315
    http://www.ncbi.nlm.nih.gov/pubmed/30443684
    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.

    European Medicines Agency © 1995-Thu Apr 18 23:26:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA