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ZOOMit-fMRI Identifies Motor Functional Cortex

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ClinicalTrials.gov Identifier: NCT03091270
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Neurosurgical Institute

Brief Summary:
This study was designed to collect a series of patients with gliomas which were involved in motor cortex to analyze difference accuracy of motor cortex localization between BOLD-fMRI and ZOOMit-fMRI.

Condition or disease
Gliomas

Detailed Description:

Gliomas will lead motor dysfunction when they are involved in motor cortex. However, tumor resection also have risk to lead postoperatively motor function deficits if destroy patients' motor cortex when tumor removed. Hence, it is important for neurosurgeon to realize the situation of patients' motor cortex locations in order to determine personal operative protocol.

The blood oxygen level dependent fMRI (BOLD-fMRI) is a prevalent preoperative method to localization motor cortex. It shows motor relevant cortex by the change of blood oxygen level when patients cooperate to finish motor tasks. The advantage of BOLD-fMRI includes higher time and spatial resolution, higher sensitivity, non-invasive. However, its accuracy of localization has not been satisfactory because neurovascular uncoupling. The ZOOMit-fMRI is a novel technic which is evolved from conventional BOLD-fMRI to localize motor functional cortex.The advantage of ZOOMit-fMRI is smaller field of view (FOV) and higher spatial resolution comparing with BOLD-fMRI. That helps to reduce other region of brain interference and elevate accuracy of localizations.

In this study, the investigators plan to enroll 60 patients, whose gliomas are involved in motor cortex, to acquire their BOLD-fMRI and ZOOMit-fMRI data in order to analyze their difference in the accuracy of motor cortex localization.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Application of ZOOMit-fMRI to Identify Motor Functional Cortex
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
BOLD-fMRI
Identifying the motor functional cortex in glioma patients with BOLD-fMRI.
ZOOMit-fMRI
Identifying the motor functional cortex in glioma patients with ZOOMit-fMRI.



Primary Outcome Measures :
  1. The accurate rate for hand motor cortex localization with BOLD-fMRI and ZOOMit-fMRI. [ Time Frame: From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient. ]
    To illustrate the accurate rate of hand motor cortex localization, the overlap indexes in BOLD-fMRI or ZOOMit-fMRI will be calculated. The results in BOLD-fMRI and ZOOMit-fMRI will be defined with 300 maximum value voxels via Statistical Parametric Mapping 8 (SPM8) software. According to the photographs and records of direct cortical stimulation (DCS) during awaken craniotomy, the DCS results will be confirmed as a global region with 5 mm diameter. Subsequently, we will overlap the BOLD-fMRI/ZOOMit-fMRI and DCS results then calculate the number of voxels overlapping. In this way, the overlap indexes can be calculated as a ratio between the number of voxels overlapping and the number of total voxels in BOLD-fMRI and ZOOMit-fMRI. We defined if the overlap index is larger than 0, the localization result is accurate. In contrast, if the overlap index is equal to zero, the localization result is inaccurate. Finally, the accurate rate of hand motor cortex localization can be calculated.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with gliomas which are closed to motor area (including primary motor area, premotor area and supplementary area), treated by awake craniotomy and intraoperative brain mapping
Criteria

The inclusion criteria were as follows: 1) age ≥ 18 years; 2) no history of surgical treatment or radiotherapy; 3) no contraindication to MRI scanning; 4) agreeable to receive the fMRI scanning and awake craniotomy with DCS.

The exclusion criteria were as follows: 1) basing on the anatomic MRI, the distance from the tumor to the hand-knob area lower than 20 mm; 2) disable to finish the task of clenching fist during fMRI scanning.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091270


Contacts
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Contact: Tao Jiang, MD and PhD +86-010-67021832 taojiang1964@163.com
Contact: Shengyu Fang, MD +8613466331405 fangtuo1@aliyun.com

Locations
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China, Beijing
Beijing Neurosurgical Institute and Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Tao Jiang, MD and PhD    +86-010-67021832    taojiang1964@163.com   
Sponsors and Collaborators
Beijing Neurosurgical Institute

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Responsible Party: Beijing Neurosurgical Institute
ClinicalTrials.gov Identifier: NCT03091270     History of Changes
Other Study ID Numbers: NSFC-81601452
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Keywords provided by Beijing Neurosurgical Institute:
gliomas
motor functional cortex
ZOOMit-fMRI
BOLD-fMRI
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue