Glioma, Motor PathwayNCT01351337
Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area
A study testing diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation in people with Glioma, Motor Pathway, run by Huashan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Glioma, Motor Pathway
- What is being tested?
- diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Hushan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery
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.
Read the 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)
- Conditions
- Glioma, Motor Pathway
- Being tested
- diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation
- Keywords
- Diffusion tensor imaging, Glioma, Intraoperative monitoring, Pyramidal tract, Subcortical, stimulation, Tractography
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion tensor tractography neuronavigation and intraoperative subcortical stimulationProcedure or surgery
All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
| Study group | Role | What they receive |
|---|---|---|
| intraoperative functional monitoring | Other | intraoperative functional monitoring Receives: Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 3 days
Secondary outcomes (1)
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.
Measured: 3 days to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioma, Motor PathwayStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Principal investigator, Jinsong Wu, Huashan Hospital
- Investigators
- Liangfu Zhou, Doctorate, Study chair, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351337
- Sponsor's protocol ID
- 07QA14008
- Other IDs
- 07QA14008
- Status last verified
- Apr 2015
- First submitted
- 9 May 2011
- Last updated
- 20 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22986591
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery
- ClinicalTrials.gov ID
- NCT01351337
- Acronym / sponsor ID
- 07QA14008
- Conditions
- Glioma, Motor Pathway
- Keywords
- Diffusion tensor imaging, Glioma, Intraoperative monitoring, Pyramidal tract, Subcortical, stimulation, Tractography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Posted 20 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraoperative functional monitoring | Other | Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulationintraoperative functional monitoring |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diffusion tensor tractography neuronavigation and intraoperative subcortical stimulationAll of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation | Procedure or surgery | intraoperative functional monitoring |
Primary outcome
Extent of Tumor Resection
Time frame: 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.
1 secondary outcome
Postoperative Motor Function and Long-time Functional Status
Time frame: 3 days to 6 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22986591Zhu 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.
Related trials for Glioma, Motor Pathway
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liangfu Zhou, Doctorate study chair
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation in people with Glioma, Motor Pathway, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of Tumor Resection (time frame: within 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.