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

NCT01351337 | Completed Results DMC

• 1 other identifier: 07QA14008
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma, Motor Pathway

Keywords

Diffusion tensor imaging, Glioma, Intraoperative monitoring, Pyramidal tract, Subcortical; stimulation, Tractography

Outcome Measures

Primary Outcomes (1)

• Extent of Tumor Resection

  Volumetric analysis was performed both before and after surgery by calculating the tumor volume on the images of enhanced 3-D MP-RAGE sequence for high-grade gliomas and FLAIR sequence for low-grade gliomas. The extent of tumor resection was the ratio of pre-op tumor volume over post-op tumor volume. Gross total resection refers to a 100% resection of the tumor volume; near-total resection refers to 95% to 100% resection; subtotal resection refers to 90% to 95% resection; partial resection refers to 75% to 90% resection; and biopsy refers to ,75% resection of the tumor volume for histological diagnosis.

  within 3 days

Secondary Outcomes (1)

• Postoperative Motor Function and Long-time Functional Status

  3 days to 6 months after surgery

Other Outcomes (1)

• The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results

  During the operation

Study Arms (1)

intraoperative functional monitoring

OTHER

intraoperative functional monitoring

Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation

Interventions

diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation PROCEDURE

All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation

intraoperative functional monitoring

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Municipal Science and Technology Commission: collaborator

Study Sites (1)

Hushan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• Zhu FP, Wu JS, Song YY, Yao CJ, Zhuang DX, Xu G, Tang WJ, Qin ZY, Mao Y, Zhou LF. Clinical application of motor pathway mapping using diffusion tensor imaging tractography and intraoperative direct subcortical stimulation in cerebral glioma surgery: a prospective cohort study. Neurosurgery. 2012 Dec;71(6):1170-83; discussion 1183-4. doi: 10.1227/NEU.0b013e318271bc61.

  PMID: 22986591 RESULT

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Limitations and Caveats

The imaged motor pathway was reconstructed based on pre-opimages. An additional study that integrates real-time DTI tractography with high-field intraoperative MRI and DsCS for eloquent cerebral glioma surgery is currently underway in our department.

Results Point of Contact

• Title: Dr Jinsong Wu
• Organization: Huashan Hospital

wjsongc@126.com

862152888771

Study Officials

• Liangfu Zhou, Doctorate

  Huashan Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 10, 2011
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: February 1, 2013
• Last Updated: April 20, 2015
• Results First Posted: April 20, 2015

Record last verified: 2015-04

Locations

CN (1)