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

• Sponsor: Huashan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01351337
• Collaborator: Shanghai Municipal Science and Technology Commission (Other)
• Enrollment: 58
• Location: 1
• Arm: 1
• Duration (Months): 52
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma, Motor Pathway	Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation	N/A

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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (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
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

1. Extent of Tumor Resection [within 3 days]

   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.

Secondary Outcome Measures

1. Postoperative Motor Function and Long-time Functional Status [3 days to 6 months after surgery]

   Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge. The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale. Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed. Grade 2: Muscle can onlly move if resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.

Other Outcome Measures

1. The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results [During the operation]

   The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative). The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive). The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jinsong Wu, professor, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT01351337
• Other Study ID Numbers: 07QA14008; 07QA14008
• First Posted: May 10, 2011
• Last Update Posted: Apr 20, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Jinsong Wu, professor, Huashan Hospital: Diffusion tensor imaging, Glioma, Intraoperative monitoring, Pyramidal tract, Subcortical; stimulation, Tractography
• Additional relevant MeSH terms: Glioma

Study Results

Participant Flow

Arm/Group Title	Intraoperative Functional Monitoring
Arm/Group Description	intraoperative functional monitoring and diffusion tensor tractography All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
Period Title: Overall Study
STARTED	58
COMPLETED	58
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intraoperative Functional Monitoring
Arm/Group Description	intraoperative functional monitoring 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
Overall Participants	58
Age (years) [Mean (Full Range) ]
Patients enrolled	44
Sex: Female, Male (Count of Participants)
Female	21 36.2%
Male	37 63.8%
Study Specific Measure [Tumor Location] (participants) [Number]
Frontal lobe	22 37.9%
Parietal lobe	13 22.4%
Insular lobe	12 20.7%
Temporal lobe	11 19%

Outcome Measures

1. Primary Outcome

Title	Extent of Tumor Resection
Description	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.
Time Frame	within 3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intraoperative Functional Monitoring
Arm/Group Description	intraoperative functional monitoring 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
Measure Participants	58
gross total resection	40 69%
near-total resection	7 12.1%
subtotal resection	7 12.1%
partial resection	4 6.9%

2. Secondary Outcome

Title	Postoperative Motor Function and Long-time Functional Status
Description	Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge. The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale. Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed. Grade 2: Muscle can onlly move if resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.
Time Frame	3 days to 6 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intraoperative Functional Monitoring
Arm/Group Description	intraoperative functional monitoring 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
Measure Participants	58
Normal	41 70.7%
Short-term motor deficit	11 19%
Long-term motor deficit	6 10.3%

3. Other Pre-specified Outcome

Title	The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results
Description	The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative). The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive). The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.
Time Frame	During the operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intraoperative Functional Monitoring
Arm/Group Description	intraoperative functional monitoring and diffusion tensor tractography All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
Measure Participants	58
Sentitivity	92.6
Specificity	93.2
Accordance rate	92.9

Adverse Events

Time Frame	Within1 week
Adverse Event Reporting Description	We recorded the peri-operative adverse events which might influence the postoperative motor function of each subject, including cavity bleeding, death.
Arm/Group Title	Intraoperative Functional Monitoring
Arm/Group Description	intraoperative functional monitoring 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
All Cause Mortality
	Intraoperative Functional Monitoring
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Intraoperative Functional Monitoring
	Affected / at Risk (%)	# Events
Total	0/58 (0%)
Other (Not Including Serious) Adverse Events
	Intraoperative Functional Monitoring
	Affected / at Risk (%)	# Events
Total	0/58 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.