ZOOMit-fMRI Identifies Language Functional Cortex

NCT ID: NCT05188534

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-12-31

Brief 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.

Detailed 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.

Conditions

Glioma

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

BOLD-fMRI

Identifying the language functional cortex in glioma patients with BOLD-fMRI

No interventions assigned to this group

ZOOMit-fMRI

Identifying the language functional cortex in glioma patients with ZOOMit-fMRI

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Neurosurgical Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Tao Jiang, MD and Ph.D

Role: CONTACT

taojiang1964@163.com

+86-010-67021832

Shengyu Fang, MD

Role: CONTACT

+8613466331405

Other Identifiers

KYSB2016-026

Identifier Type: -

Identifier Source: org_study_id