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Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area

This study has been completed.
Sponsor:
Collaborator:
Shanghai Municipal Science and Technology Commission
Information provided by (Responsible Party):
Jinsong Wu, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01351337
First received: May 9, 2011
Last updated: September 22, 2013
Last verified: September 2013
  Purpose

Resection of brain tumors in eloquent areas involves the risk of postoperative motor deficits. For brain tumors within or adjacent to the eloquent area, maximizing tumor resection while preserving motor function is crucially important.we used DTI-based tractography to visualize the spatial relationship between brain lesions and the nearby pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional connections of the illustrated PT by direct electrical stimulation. We evaluated the reliability of DTI-based tractography for PT mapping using intraoperative subcortical stimulation ) and the usefulness of the combination of two techniques.


Condition Intervention
Glioma, Motor Pathway
Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery

Resource links provided by NLM:


Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • Extent of tumor resection and the integrity of the PTs confirmed by postoperative MRI [ Time Frame: within 3 days ] [ Designated as safety issue: No ]
    The postoperative volumetric analysis showed gross total resection in 40 subjects (69.0%), near-total resection in 7 subjects (12.1%), subtotal resection in 7 subjects (12.1%), and partial resection in 4 subjects (6.9%).


Secondary Outcome Measures:
  • postoperative motor function and long-time functional status assessed clinically [ Time Frame: more than 6 months ] [ Designated as safety issue: No ]
    Seventeen subjects (29.3%) experienced postoperative worsening, and 11 recovered to a normal status by their 1-month follow-up. Six subjects (10.3%), including the 2 subjects with postoperative bleeding, suffered from 1-month motor deficit.


Other Outcome Measures:
  • The safety margin for PT preservation. [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
    DsCS verified a high accordance rate with DTI tractography for the purposes of PT mapping. The sensitivity of DTI for PT mapping was 92.6% (95% confidence interval [CI], 85.6-99.6) and specificity was 93.2% (95% CI, 86.8-99.6).In terms of the response to the stimulation considering the isolated points, the sensitivity of DTI for PT mapping was 95.9% (95% CI, 91.9-99.8) and the specificity was 82.1% (95% CI, 75.1- 89.2). DsCS verified a high accordance rate with DTI tractography in 92.9% of all subjects The area under the ROC curve was 0.97 (95% CI, 0.94-0.99), with extremely high discriminatory power. If we set the cutoff value between 8.0 and 8.6 mm, both the sensitivity and specificity were .90%.


Enrollment: 58
Study Start Date: October 2008
Study Completion Date: February 2013
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
intraoperative functional monitoring
intraoperative functional monitoring
Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation
All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation

Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01351337

Locations
China, Shanghai
Hushan Hospital, Fudan University
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Huashan Hospital
Shanghai Municipal Science and Technology Commission
Investigators
Study Chair: Liangfu Zhou, Doctorate Huashan Hospital, Fudan University
  More Information

Publications:
Responsible Party: Jinsong Wu, professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01351337     History of Changes
Other Study ID Numbers: 07QA14008, 07QA14008
Study First Received: May 9, 2011
Last Updated: September 22, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Huashan Hospital:
Diffusion tensor imaging, Glioma, Intraoperative monitoring, Pyramidal tract, Subcortical
stimulation, Tractography

Additional relevant MeSH terms:
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 20, 2014