ZOOMit-fMRI Identifies Language Functional Cortex

Glioma Clinical Trial

Official title:

The Application of ZOOMit-fMRI to Identify Language Functional Cortex

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05188534
• Other study ID #: KYSB2016-026
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Glioma

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.