Trial document




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  DRKS00003306

Trial Description

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Title

7 Tesla MR spectroscopy in diffusely infiltrating gliomas

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Proton magnetic resonance spectroscopic imaging (1H-MRSI) enables the assessment of local changes in brain metabolism that underlie many brain diseases such as brain tumors. 1H-MRSI is a valuable tool for treatment planning. However, available 1H-MRSI methods at clinical MR scanners are restricted by several practical limitations. Our preliminary results show that 7 Tesla MR spectroscopy can help to overcome these limitations (i.e. low spatial resolution).
The aim of this project is to improve the quality of 1H-MRSI results by better hardware (i.e. 7T MR scanner and improved RF coils) and by improved acquisition methods.
After first validation of the technique in healthy volunteers, the additional value of high resolution 1H-MRSI will be explored in a selected group of 40 patients with brain tumors. It will be evaluated if the new method helps to improve the pre-operative planing before brain surgery.
After first successful application of high resolution 1H-MRSI, our method can be readily extended to investigations of other neurological diseases such as epilepsy, multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, psychiatric and metabolic disorders.

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Brief Summary in Scientific Language

Proton magnetic resonance spectroscopic imaging (1H-MRSI) enables the non-invasive assessment of local changes in brain metabolism that underlie many brain diseases such as brain tumors. 1H-MRSI can improve brain tumor grading, differential diagnosis, detection of tumor foci, and assessment of tumor infiltration. This makes 1H-MRSI a valuable tool for treatment planning. However, available 1H-MRSI methods at clinical MR scanners (≤3 Tesla) are restricted by several practical limitations. Our preliminary results show that novel 1H-MRSI methods at ultra-high magnetic field strength (i.e. 7 Tesla) can help to overcome these limitations (i.e. low spatial resolution).
The aim of this project is to improve the quality of 1H-MRSI results by better hardware (i.e. 7T MR scanner and improved RF coils) and by improved acquisition methods. The further development of an improved 1H-MRSI sequence for 7T based on our initial results should enable 3D metabolic mapping of pathologic brain areas within reasonable scans times.
After first validation of the technique in healthy volunteers, the additional value of high resolution 1H-MRSI will be explored in a selected group of 40 patients with diffusely infiltrating glioma (DIG). The extent of the infiltration area and tumor foci in DIG is difficult to assess by other imaging modalities. Hence, DIG are a suitable model to demonstrate the advantages of high resolution 1H-MRSI at 7T. Metabolic maps obtained by 1H-MRSI will be incorporated into the neuronavigation system. Stereotactic biopsies will be taken. A topographic correlation between metabolic maps and histopathology will be performed.
After first successful application of high resolution 1H-MRSI, our method can be readily extended to investigations of other neurological diseases such as epilepsy, multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, psychiatric and metabolic disorders.

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Organizational Data

  •   DRKS00003306
  •   2011/10/18
  •   [---]*
  •   yes
  •   Approved
  •   Ek.-Nr. 106/2011, Ethikkommission der Medizinischen Universität Wien Borschkegasse 8b/E06 1090 Wien http://ethikkommission.meduniwien.ac.at/ethik-kommission/
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Secondary IDs

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Health Condition or Problem studied

  •   C71.9 -  Malignant neoplasm: Brain, unspecified
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Proton magnetic resonance spectroscopic imaging at 7 Tesla in brain tumor patients (glioma)
  •   Proton magnetic resonance spectroscopic imaging at 7 Tesla in healthy subjects
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Characteristics

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

Development of an improved magnetic resonance spectroscopy sequence for 7 Tesla for three-dimensional metabolic mapping of pathologic brain areas.

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Secondary Outcome

Successful clinical evaluation of developed 7 Tesla magnetic resonance spectroscopy method on brain tumor patients in comparison to healthy controls.

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2012/01/01
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

-(in case of patients) radiologically verified brain tumor (diffus infiltrating glioma, WHO grade II-IV)
-(in case of patients) adequate performance score (Karnofsky score >70%)

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Exclusion Criteria

-pregnancy
-any contraindications for MR imaging
-pacemaker
-(in case of volunteers) disease of the central nervous system (especially the brain)

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Addresses

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    • MR Exzellenzzentrum, Universitätsklinik für Radiodiagnostik, Medizinische Universität Wien
    • Mr.  Dr.  Wolfgang  Bogner 
    • Lazarettgasse 14
    • 1090  Wien
    • Austria
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    • MR Exzellenzzentrum, Universitätsklinik für Radiodiagnostik, Medizinische Universität Wien
    • Mr.  Dr.  Wolfgang  Bogner 
    • Lazarettgasse 14
    • 1090  Wien
    • Austria
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    • MR Exzellenzzentrum, Universitätsklinik für Radiodiagnostik, Medizinische Universität Wien
    • Mr.  Dr.  Wolfgang  Bogner 
    • Lazarettgasse 14
    • 1090  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Fonds zur Förderung der wissenschaftlichen Forschung (FWF)
    • Haus der Forschung, Sensengasse 1
    • 1090  Wien
    • Austria
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Status

  •   Recruiting planned
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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.