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Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery


N/A
6 Years
75 Years
Open (Enrolling by invite only)
Both
Glioma

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Trial Information

Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery


Adverse effects caused by electrical stimulation during the operation were recorded. All
subjects adopted early postoperative MRI examinations (within 3 days) to evaluate both the
extent of tumor resection and the integrity of the PTs. Muscle strength was assessed
preoperatively and postoperatively.The Karnofsky Performance Scale (KPS) was adopted for
grading functional status at the 6-month evaluation. Further tumor progression interval and
survival analysis was conducted for each subject with high-grade glioma (HGG)


Inclusion Criteria:



- patients with an initial imaging diagnosis of single, unilateral, supratentorial
primary glioma (or intrinsic neoplasm).

- The lesions were involved in PTs, comprising cortical regions in the motor or
somatosensory areas, cortical regions adjacent to the central gyrus, subcortical
regions with an infiltrative progression along the PTs, and temporal or insular
regions in relation to the internal capsule.

- MRI enabled preoperative identification of patients in whom maximal tumor resection
was likely to be achieved, and close PT approach within resection cavity at the time
of surgery was possible.

Exclusion Criteria:

- patients with secondary or recurrent gliomas (or intrinsic neoplasm), patients with
contraindications for MRI or direct electrical stimulation, and patients in whom
initial muscle strength grades of the affected extremities was 2/5 or lower.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Extent of tumor resection and the integrity of the PTs confirmed by postoperative MRI

Outcome Time Frame:

within 3 days

Safety Issue:

No

Principal Investigator

Liangfu Zhou, Doctorate

Investigator Role:

Study Chair

Investigator Affiliation:

Huashan Hospital, Fudan University

Authority:

China: Food and Drug Administration

Study ID:

07QA14008

NCT ID:

NCT01351337

Start Date:

October 2008

Completion Date:

November 2011

Related Keywords:

  • Glioma
  • Pyramidal tract
  • Diffusion tensor imaging
  • Intraoperative monitoring
  • Tractography Neuronavigation
  • Subcortical stimulation
  • Glioma

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