Trial document




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  DRKS00003118

Trial Description

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Title

Clinical Use of Different Fiber Tractography Methods in Epilepsy Surgery

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Trial Acronym

KAFEe

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The human brain consists of grey and white matter. Grey matter contains neurons, whereas white matter contains the fibers conducting the signals from the neurons. Magnetic Resonance Imaging allows the depiction of the course of fibre bundles in the brain. There are several methods to calculate the fibre tracts of which three shall be compared to each other.
Fibertracking of the brain is especially important for neurosurgical planning in advance to an operation of epilepsy, because it is intended, to preserve the fibre tracts which pass adjacent to an illness as far as possible. The purpose of this retrospective study on data of earlier operated patients is to find out, which of the three methods is best for fibre tracking of the brain.
As a direct proof of a correct depiction of fibres is not possible in the living human, the fibre tracking by those three methods in the pre-operative data set will be compared with possible unavoidable neurological deficits after operation to find out, whether parts of particular fibre tracts were affected by the operation. Additionally, the pre-operatively assessed fibre tracts will be compared with post-operative imaging data sets, to depict the exact place of partial damage of the fibers. In cases without any damage, the extent and the anatomical course of the depicted fibres will be compared for all three methods.

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Brief Summary in Scientific Language

In the literature (Nimsky et al., 2005; Nimsky et al., 2006; Okada et al., 2006), presurgical fibre tracking is recommended for the depiction of functionally critical fibre pathways, commonly using the FACT algorithm (Mori et al., 1999).
Probability Maps (Parker et al. 2003) providing also the depiction of fibres with a stronger bending are increasingly used (Ciccarelli et al., 2003). These both methods use a circumscribed, local approach for the depiction of fibers, whereas a new approach for a global fibre reconstruction has been developed in the Dept. of Medical Physics of the Radiological University Hospital Freiburg ("Gibbs Tracking", Kreher et al. 2008; "Global Tracking" Reisert et al. 2010). The advantage of this newly proposed method is the possibility to depict fibres also across fibre crossings.
The purpose of this retrospective study is to find out which of the three proposed methods (FACT, Probability Maps und Global Tracking) is best suited to depict fibre pathways in the brain of epilepsy patients, and whether different fibre systems with particular anatomical characteristics have potentially to be investigated by different algorithms.
As a direct proof of a correct depiction of fibres is not possible in the living human, fibre tracking by using these three methods will be performed in pre-operative data sets of patients with epilepsy, and will be compared with possible unavoidable neurological deficits after operation to find out, whether parts of particular fibre tracts could not be preserved during operation. Postoperative evaluation routinely consists of a neurological examination and postoperative imaging after three months. Additionally, the pre-operatively assessed fibre tracts will be compared with post-operative imaging data sets to depict the exact place of partial damage of the fibers. Thus, the correct depiction of the fibre pathways is controlled by a lesion study. In cases without any damage, the extent and the anatomical course of the depicted fibres will be compared for all three methods.

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Organizational Data

  •   DRKS00003118
  •   2011/06/28
  •   [---]*
  •   yes
  •   Approved
  •   217/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   G40.2 -  Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
  •   G40.4 -  Other generalized epilepsy and epileptic syndromes
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Interventions/Observational Groups

  •   No intervention. MRT data of epilepsy patients are analysed by the FACT algorithm.
  •   No intervention. MRT data of epilepsy patients are analysed by the Probability Map algorithm.
  •   No intervention. MRT data of epilepsy patients are analysed by the Global Tracking algorithm.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

In advance to the comparison of the three different fibre tracking algorithms, three prior steps have to be performed before the final 4th step (comparsion) can be done.

1. Estimation of the neurological findings 3 months after operation, documentation on CRF.

2. Estimation of the resection borders to delinaeate the lesion size, voxel-based electronical documentation.

3. Deduction of the fiber course from the lesion caused by operation and their neurologic-topic sequels, voxel-based electronical documentation.

4. Evaluation, which fibre tracking algorithm has correctly depicted the concerned part of the fibre pathway, voxel-based electronical documentation, documentaion as table.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/07/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   65   Years
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Additional Inclusion Criteria

Indication for epilepsy surgery

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Exclusion Criteria

Contraindications against MRI

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Addresses

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    • Neurozentrum des Universitätsklinikums Freiburg Abteilung für Neuroradiologie
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Neurozentrum des Universitätsklinikums Freiburg Abteilung Neuroradiologie
    • Mr.  Constantin  Anastasopoulos 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Neurozentrum der Universitätsklinik Freiburg Abteilung Neuroradiologie
    • Ms.  Susanne  Olschok 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Neurozentrum des Universitätsklinikums Freiburg Abteilung für Neuroradiologie
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/11/30
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Trial Publications, Results and other Documents

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