Glioma, Motor Pathway
Conditions
Keywords
Diffusion tensor imaging, Glioma, Intraoperative monitoring, Pyramidal tract, Subcortical, stimulation, Tractography
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.
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)
Interventions
PROCEDUREdiffusion 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
Sponsors
Shanghai Municipal Science and Technology Commission
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraoperative Functional Monitoring 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 | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | Intraoperative Functional Monitoring |
|---|---|
| Age, Continuous Patients enrolled | 44 years |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 37 Participants |
| Study Specific Measure [Tumor Location] Frontal lobe | 22 participants |
| Study Specific Measure [Tumor Location] Insular lobe | 12 participants |
| Study Specific Measure [Tumor Location] Parietal lobe | 13 participants |
| Study Specific Measure [Tumor Location] Temporal lobe | 11 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
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.
Time frame: within 3 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intraoperative Functional Monitoring | Extent of Tumor Resection | gross total resection | 40 participants |
| Intraoperative Functional Monitoring | Extent of Tumor Resection | near-total resection | 7 participants |
| Intraoperative Functional Monitoring | Extent of Tumor Resection | subtotal resection | 7 participants |
| Intraoperative Functional Monitoring | Extent of Tumor Resection | partial resection | 4 participants |
Secondary
Postoperative Motor Function and Long-time Functional Status
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intraoperative Functional Monitoring | Postoperative Motor Function and Long-time Functional Status | Normal | 41 participants |
| Intraoperative Functional Monitoring | Postoperative Motor Function and Long-time Functional Status | Short-term motor deficit | 11 participants |
| Intraoperative Functional Monitoring | Postoperative Motor Function and Long-time Functional Status | Long-term motor deficit | 6 participants |
Other Pre-specified
The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intraoperative Functional Monitoring | The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results | Sentitivity | 92.6 percentage of stimulation sites |
| Intraoperative Functional Monitoring | The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results | Specificity | 93.2 percentage of stimulation sites |
| Intraoperative Functional Monitoring | The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results | Accordance rate | 92.9 percentage of stimulation sites |