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

This study is enrolling participants by invitation only.

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: November 20, 2011

Last verified: March 2011

History of Changes

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	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:

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

postoperative motor function and long-time functional status assessed clinically [ Time Frame: more than 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	55
Study Start Date:	October 2008
Estimated Study Completion Date:	November 2011
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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:

Wu JS, Zhou LF, Tang WJ, Mao Y, Hu J, Song YY, Hong XN, Du GH. Clinical evaluation and follow-up outcome of diffusion tensor imaging-based functional neuronavigation: a prospective, controlled study in patients with gliomas involving pyramidal tracts. Neurosurgery. 2007 Nov;61(5):935-48; discussion 948-9.

Berman JI, Berger MS, Chung SW, Nagarajan SS, Henry RG. Accuracy of diffusion tensor magnetic resonance imaging tractography assessed using intraoperative subcortical stimulation mapping and magnetic source imaging. J Neurosurg. 2007 Sep;107(3):488-94.

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:	November 20, 2011
Health Authority:	China: Food and Drug Administration

Keywords provided by Huashan Hospital:

Pyramidal tract
Diffusion tensor imaging
Intraoperative monitoring
Tractography Neuronavigation
Subcortical stimulation

Additional relevant MeSH terms:

Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 16, 2013

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