Trial document




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  DRKS00008794

Trial Description

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Title

Mesoscopic Detection of Focal Cortical Signal Alterations

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Trial Acronym

MesDeFoCoS

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URL of the Trial

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Brief Summary in Lay Language

Benign brain tumors can cause pharmaco-resistant epilepsy in children, adolescents and young adults. In this case or in case of tumor growth, an operation can be performed. Due to a different tissue composition of the tumors, they may recur in varying frequencies. Thus it is interesting and important, whether diffusion metrics are able to distinguish between those tumors. Diffusion metrics describe the mobility of hydrogen nuclei along or perpendicular to the neural fibers or between cells.
Therefore diffusion weighted images being primarily used for preoperative fiber tracking were retrospectively analysed concerning the discrimination of the different pathologies.

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Brief Summary in Scientific Language

LEATs (Low grade Epilepsy Associated Tumors) are benign and low grade brain tumors leading to epilepsy. They predominantly comprise dysembryoplastic neuroepithelial tumors (DNET) WHO grade °I and gangliogliomas WHO Grade °I. DNETS are benign intracortical lesions based on and embedded in a focal cortical dysplasia. They occur in children, adolescents and young adults, mostly < 20 years. Gangliogliomas are development-related epilepsy-associated tumors with atypical ganglion cells in combination with neoplastic glial cells in children, adolescents and young adults, mostly <30 years. Both entities undergo an operation, if the epilepsy is pharmaco-resistant or the tumor is growing. In principle, gangliogliomas recur more often than DNETs because of their glial element. Therefore, it is interesting to differentiate both entities prior to operation. But this is not straightforward on the basis of qualitative structural imaging.

Diffusion weighted imaging allows an assessment of the microscopic structure of the brain tissue, even though the spatial resolution of the images is larger than the microscopic scale (hence the name mesoscopic imaging). From diffusion weighted data, being used in clinical application for pre-operative fiber tracking of functional relevant fiber structures, it is possible to calculate diffusion metrics per pixel that permit quantitative statements about the microstructure. These include the apparent diffusion coefficient (ADC), fractional anisotropy (FA, a measure of the directionality), axial (AD, along the main diffusion direction) and radial diffusivity (RD, diffusion perpendicular to the main direction). Moreover, it is possible to calculate the fiber direction for the same data sets.

The goal of this retrospective study is to calculate the above mentioned diffusion metrics (FA, ADC, AD, RD) from the pre-operative diffusion data within the lesion and its surroundings.
Furthermore, local fiber courses in the direct vicinity of the lesion will be evaluated by Global Tracking to assess the integrity of the U-fibers, and will be compared to the contralateral normal appearing matter.

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Organizational Data

  •   DRKS00008794
  •   2015/10/09
  •   2015/06/18
  •   yes
  •   Approved
  •   283/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   D33.9 -  Benign neoplasm: Central nervous system, unspecified
  •   Q04.9 -  Congenital malformation of brain, unspecified
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Interventions/Observational Groups

  •   Comparsion of diffusion metrics such as Mean Diffusivity, Apparent Diffusion Coefficient, Axial and Radial Diffusivity in different part of the tumor (solid, cystic, without, with contrast enhancement), in the adjacent tissue and in contralateral normal appearing matter, between three groups, the first being:
    Dysembryoblastic neuroepithelial tumor ICD10 - D33.9
  •   Ganglioglioma ICD10 - D33.9
  •   Focal cortical dysplasia ICD10 - Q04.9
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The calculation of diffusion parameters of each pathology.

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Secondary Outcome

Group-wise comparison of the diffusion parameters using parametric or non-parametric tests.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with Dysembryoplastic Neuroectodermal Tumors, Gangliogliomas and Focal Cortical Dysplasias and preoperative 3D- and diffusion imaging.

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Exclusion Criteria

Poor image quality

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Klinik für Neuroradiologie
    • Ms.  Prof. Dr.  Irina  Mader 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Klinik für Neuroradiologie
    • Ms.  Ulrike  Bergmann 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/01/29
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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.