Trial document





This trial has been registered retrospectively.
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  DRKS00015163

Trial Description

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Title

Contrast enhanced 3D T1w with blood suppression and compressed sensing at 3T - Evaluation of cerebral venous sinus infiltration of meningiomas.

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Trial Acronym

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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

Imaging venous sinus infiltration of meningiomas is mandatory for the therapeutically planning and the outcome of the patient, because tumor occlusion can lead to severe neurological complications and resection of infiltrating meningiomas has a higher recurrence rate and a potential risk of damage to the venous system.
The purpose of the study is to evaluate the cerebral venous vessel infiltration of meningiomas by using a contrast enhanced accelerated 3D T1w black blood fast-spin-echo sequence using compressed sensing (CS-SPACE) at 3T. This sequence may replace the routinely used 2D TOF Venography and the contrast enhanced T1 MPRAGE.

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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

  •   DRKS00015163
  •   2018/09/19
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  •   yes
  •   Approved
  •   206/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   D32.0 -  Benign neoplasm: Cerebral meninges
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Interventions/Observational Groups

  •   Patients in this study obtain an additional MRI-sequence (3D T1w black blood fast-spin echo sequence using compressed sensing) beside the standard MRI-protocoll. The additional sequence takes 7 minutes. No additional contrast medium is administered.
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Characteristics

  •   Non-interventional
  •   Other
  •   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

Radiological agreement of CS-SPACE with combination of 2D TOF and T1w MPRAGE in assessment of venous sinus infiltration

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Secondary Outcome

Radiological agreement of CS-SPACE with combination of 2D TOF and T1w MPRAGE in assessment of tumor infiltration of cortical veins
- Compare CS-SPACE with MPRAGE concerning tumor signal and motion artifacts

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/07/17
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patient send to our radiology department with suspected meningioma adjacent to venous sinus.

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Exclusion Criteria

contraindication to mri oder mri contrast agent. Pregnancy

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Addresses

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    • Klinik für Neuroradiologie Universitätsklinikum Freiburg
    • Breisacher Strasse 64
    • 79106   Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Neuroradiologie
    • Mr.  Dr.  Philippe  Dovi-Akue 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Neuroradiologie
    • Mr.  Dr.  Philippe  Dovi-Akue 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neuroradiologie Universitätsklinikum Freiburg
    • Breisacher Str. 65
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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