Trial document




This trial has been registered retrospectively.
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  DRKS00008994

Trial Description

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Title

Spinal Diffusion Tensor Imaging (DTI) in intramedullary Tumors- diagnosis of Tumor entity and planning of surgical strategy

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Trial Acronym

spinDTI

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Magnetic resonance imaging is the gold standard for differentiation of spinal intramedullary lesions because of the highest lesion perceptibility and local resolution [Wolf 2012]. Additional information can be given by specific MR Diffusion Tensor Imaging (DTI) with detection of proton diffusion tensor and associated tissue microstructure in combination with local fiber tracking. Ischemic and traumatic spinal pathologies can mostly be diagnosed by anamnestic and clinical presentation. The differentiation of inflammatory and neoplastic lesions, as well as the specific spinal tumor entities themselves, seems to be challenging. On target is the noninvasive primary diagnosis [Liu 2014]. In recent literature the misdiagnosis of spinal tumors with following biopsy or resection and pathologic demonstration of mostly inflammatory demyelinating disease is described in up to 16% [Wang 2013, Lee 1998, Selviaridis 2007]. To reduce the rate of misdiagnosis can protect those patients for unnecessary surgical complications.
The advanced application of spinal tractography can improve the imaging of the relationship of those lesions and healthy eloquent surrounding tissue to increase primary diagnosis. DTI has been evaluated intensively for ischemic, traumatic and inflammatory spinal lesions, but only limited concerning neoplastic pathologies [Bihan 2001; Clark 2002; Vargas 2007]. Intracranial neoplastic lesions have been investigated more intensive [Bihan 2001; Witwer 2002; Bammer 2003], so that for cranial tumor surgery this method is already established [Potgieser 2014]. Our focus is the distinction of neoplastic to inflammatory lesions, that don’t have to undergo any surgical treatment and the neoplastic entities under themselves.

So aim of this study was to evaluate fiber characteristics of the spinal cord in relation to neoplastic and inflammatory spinal intramedullary lesions. We wanted to improved primary diagnosis to prevent surgical treatment in inflammatory lesions, delineate the intraspinal tumor entities from each other and therefore optimize management of those patients.

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Organizational Data

  •   DRKS00008994
  •   2016/02/17
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  •   yes
  •   Approved
  •   145/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   spinal tumors
  •   D43 -  Neoplasm of uncertain or unknown behaviour of brain and central nervous system
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Interventions/Observational Groups

  •   Pre-surgery:
    - admission to clinic with suspected diagnosis of an intramedullary tumor
    - patients history and clinical examination
    - spinal MRI with additional DTI sequence
    - determination of the treatment based on clinical and radiological information
    - perhaps additional examinations.

    Biopsy or resection of intramedullary tumor.

    Post-surgery:
    - clinical examination
    - description of the intraoperative findings from the neurosurgeon
    - histological diagnosis
    - assessment of clinical development and examination on discharge
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

sensitivity and specifity for tumor entity using spinal DTI for intramedullary tumors

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Secondary Outcome

spinal fiber tracking to optimize surgical approach to the spinal tumor

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/07/23
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

suspected intramedullary tumor and possibility to informed consent

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Exclusion Criteria

MRI contraindications (Pacemaker, foreign bodies, cuttings, Clips in Brain, eyball, lung, next to blood vessels, middle and inner ear implants

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Addresses

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    • Klinik für Neurochirurgie, Universitätsklinikum Freiburg
    • Breisacher Str. 64
    • 79102  Freiburg
    • Germany
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    • Klinik für Neurochirurgie Universitätsklinikum Freiburg
    • Mr.  Dr.  Marc  Hohenhaus 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Klinik für NeurochirurgieUniversitätsklinikum Freiburg
    • Mr.  Dr.  Marc  Hohenhaus 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neurochirurgie, Universitätsklinikum Freiburg
    • Breisacher Str. 64
    • 79102  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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