Trial document




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  DRKS00016920

Trial Description

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Title

Retrospective analysis of imaging modalities acquired during clinical diagnosis of patients with clinical suspected neurodegenerative Parkinsonian syndrome

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Trial Acronym

MOPET

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study consists in retrospective analysis of imaging modalities acquired in patients with clinical suspected neurodegenerative Parkinsonian syndrome for correlation between different modalities and with clinical parameter. Potential progression parameter will be identified.

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Brief Summary in Scientific Language

We object to characterize patients with clinical suspected Parkinsonian syndrome by multimodal imaging parameter together with clinical scoring. Midbrain atrophy, retinal layer thickness and tau quantification will be analyzed and correlated with clinical scoring.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016920
  •   2019/03/18
  •   [---]*
  •   yes
  •   Approved
  •   19-022, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G20 -  Parkinson disease
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Interventions/Observational Groups

  •   Quantitative analysis of cMRI and/or OCT and/or tau-PET in patients with probable or possible progressive supranuclear palsy
  •   Quantitative analysis of cMRI and/or OCT and/or tau-PET in patients with probable or possible tau-negative Parkinsonian syndrome
  •   Quantitative analysis of cMRI and/or OCT and/or tau-PET in historically examined healthy controls
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical, Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

For patients with cMRT the midbrain diameter and the midbrain to pons ratio will be acquired.

For patients with OCT the thickness of retinal layers will be accessed.

For patients with tau-PET the regional signal in defined target regions (midbrain, globus pallidus, nucleus dentatus, frontal cortex) will be quantified.

The quantification will be performed retrospectively and linked to the acqusition date. Specific software will be used for quantification (i.e. PMOD Technologies, Basel, Switzerland).

The primary endpoint consists in correlation of cMRI, OCT, and tau-PET quantification with disease severity for patients with Progressive Supranuclear Palsy.

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Secondary Outcome

Quantification of cMRI, OCT, and tau-PET will be compared between patients with probable and possible Progressive Supranuclear Palsy, patients with probable tau-negative Parkinsonian syndrome and healthy controls.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/03/31
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   90   Years
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Additional Inclusion Criteria

clinical suspected neurodegenerative Parkinsonian Syndrome and acquisition of at least one of the following modalities: cMRI, OCT, tau-PET

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Exclusion Criteria

other non-neurodegenerative CNS diseases like glioma or stroke

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik und Poliklinik für Nuklearmedizin, LMU München
    • Mr.  Dr.  Matthias  Brendel 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Nuklearmedizin, LMU München
    • Mr.  Dr.  Matthias  Brendel 
    • Marchioninistraße 15
    • 81377  München
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Klinik und Poliklinik für Nuklearmedizin, LMU München
    • Mr.  Dr.  Matthias  Brendel 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Nuklearmedizin, LMU München
    • Mr.  Dr.  Matthias  Brendel 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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