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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05188534
Other study ID # KYSB2016-026
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date December 31, 2022

Study information

Verified date December 2021
Source Beijing Neurosurgical Institute
Contact Tao Jiang, MD and Ph.D
Phone +86-010-67021832
Email taojiang1964@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This Study was designed to collect a series of patients with gliomas which were involved in language related cortex to analyze difference accuracy of language related cortex localization between BOLD-fMRI and ZOOMit-fMRI.


Description:

Gliomas can cause language dysfunction when they are involved in language related cortex. However, tumor resection also have risk to lead postoperatively language function deficits if destroy patients' language related cortex when tumor removed. Hence, it is important for neurosurgeon to realize the situation of patients' language related cortex locations in order to determine personal operative protocol. The blood oxygen level dependent fMRI (BOLD-fMRI) is a prevalent preoperative method to localization language related cortex. It shows language relevant cortex by the change of blood oxygen level when patients cooperate to finish language 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 language functional cortex.The advantage of ZOOMit-fMRI is smaller field of view (FOV) and higher spatial resolution comparing with BOLD-fMRI which 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 language related cortex, to acquire their BOLD-fMRI and ZOOMit-fMRI data in order to analyze their difference in the accuracy of language related cortex localization.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 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 Exclusion Criteria: 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Beijing Neurosurgical Institute and Beijing Tiantan Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The accurate rate for language related cortex localization with BOLD-fMRI and ZOOMit-fMRI To illustrate the accurate rate of language functional 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, the overlap of the BOLD-fMRI/ZOOMit-fMRI and DCS results will be calculated. 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 language functional cortex localization can be calculated. From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient.
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