ZOOMit-fMRI Identifies Language Functional Cortex

The Application of ZOOMit-fMRI to Identify Language Functional Cortex

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioma

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Tao Jiang, MD and Ph.D; Phone Number: +86-010-67021832; Email: taojiang1964@163.com
• Study Contact Backup: Name: Shengyu Fang, MD; Phone Number: +8613466331405

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with gliomas which are closed to language related area (Broca area and Wernicke area), treated by awake craniotomy and intraoperative brain mapping.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
BOLD-fMRI; Identifying the language functional cortex in glioma patients with BOLD-fMRI
ZOOMit-fMRI; Identifying the language functional cortex in glioma patients with ZOOMit-fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Beijing Neurosurgical Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: December 26, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: ZOOMit-fMRI; Language functional cortex
• Other Study ID Numbers: KYSB2016-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No