Trial document





This trial has been registered retrospectively.
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  DRKS00003613

Trial Description

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Title

Prospective comparison of FDG-PET and IBZM-SPECT in the differential diagnosis of parkinsonism

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The major objective of our study is to improve the diagnostic accuracy of uncertain parkinsonism. In particular at early stages of disease the clinical diagnosis is challenging. Neuroimaging techniques contribute to the correct diagnosis of parkinsonism. Potential study participants are patients who suffer from symptoms of parkinsonism. Our study aims for a a head-to-head comparison of two radioactive imaging methods (FDG-PET and IBZM-SPECT). FDG-PET is radioactive imaging of glucose metabolism of nerve cells. IBZM-SPECT is radioactive imaging of dopamine receptor in the brain. Dopamin is a transmitter which is decreased in the brain of parkinsonian patients.

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Brief Summary in Scientific Language

Imaging of regional cerebral glucose metabolism with positron emission tomography (PET) and striatal dopamine D2/D3 receptors (D2R) with single-photon emission computed tomography (SPECT) improves the differential diagnosis of parkinsonism. We prospectively investigated (1.) the diagnostic merits of these approaches in differentiating between Lewy body diseases (LBD; majority Parkinson’s disease, PD) and atypical parkinsonian syndromes (APS); (2.) the diagnostic value of [18F]FDG-PET to differentiate among APS subgroups.

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Organizational Data

  •   DRKS00003613
  •   2012/03/12
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  •   yes
  •   Approved
  •   361/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson's disease
  •   G23.1 -  Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]
  •   G31.0 -  Circumscribed brain atrophy
  •   G90.3 -  Multi-system degeneration
  •   G31.88 -  [generalization G31.8: Other specified degenerative diseases of nervous system]
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Interventions/Observational Groups

  •   Patients with clinically suspected atypical parkinsonian syndromes (based on clinical symptoms and poor response to levodopa) receive IBZM-SPECT. All patients were clinically followed up for at least 6 months for final clinical diagnosis.
  •   Patients with clinically suspected atypical parkinsonian syndromes (based on clinical symptoms and poor response to levodopa) receive FDG-PET. All patients were clinically followed up for at least 6 months for final clinical diagnosis.
    The same study sample receives first IBZM-SPECT (Arm1) and subsequently FDG-PET.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

diagnostic accuracy of IBZM-SPECT and FDG-PET to differentiate between atypical parkinsonian syndromes and Lewy body diseases (Parkinson´s disease, Parkinson´s disease with dementia, Dementia with Lewy bodies) given as area under the receiver operating characteristics

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Secondary Outcome

diagnostic accuracy of FDG-PET to differentiate between subgroups of atypical parkinsonian disorders (progressive supanuclear palsy, corticobasal degeneration, multiple system atrophy), diagnostic measures are sensitivity, specificity, negative predictive value, positive predictive value

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/07/05
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

suspected, but not yet verified early-stage atypical parkinsonian syndrome based on clinical symptoms and poor response to levodopa; Karnofsky score ≥40%)

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Exclusion Criteria

relevant impairment or significant reduction of life expectancy caused by another disease

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Addresses

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Sources of Monetary or Material Support

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    • Abteilung für Nuklearmedizin, Universitätsklinikum Freiburg
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/06/27
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.