Trial Outcomes & Findings for Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area (NCT NCT01351337)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

within 3 days

Results posted on

2015-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Intraoperative Functional Monitoring 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
Overall Study STARTED	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intraoperative Functional Monitoring n=58 Participants 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
Age, Continuous Patients enrolled	44 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Study Specific Measure [Tumor Location] Frontal lobe	22 participants n=5 Participants
Study Specific Measure [Tumor Location] Parietal lobe	13 participants n=5 Participants
Study Specific Measure [Tumor Location] Insular lobe	12 participants n=5 Participants
Study Specific Measure [Tumor Location] Temporal lobe	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intraoperative Functional Monitoring n=58 Participants 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
Extent of Tumor Resection subtotal resection	7 participants
Extent of Tumor Resection partial resection	4 participants
Extent of Tumor Resection gross total resection	40 participants
Extent of Tumor Resection near-total resection	7 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intraoperative Functional Monitoring n=58 Participants 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
Postoperative Motor Function and Long-time Functional Status Normal	41 participants
Postoperative Motor Function and Long-time Functional Status Short-term motor deficit	11 participants
Postoperative Motor Function and Long-time Functional Status Long-term motor deficit	6 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intraoperative Functional Monitoring n=58 Participants 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
The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results Sentitivity	92.6 percentage of stimulation sites
The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results Specificity	93.2 percentage of stimulation sites
The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results Accordance rate	92.9 percentage of stimulation sites

Adverse Events

Intraoperative Functional Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jinsong Wu

Huashan Hospital

Phone: 862152888771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place