ZOOMit-fMRI Identifies Language Functional Cortex

NCT05188534 | Unknown

• 1 other identifier: KYSB2016-026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

Language functional cortex; ZOOMit-fMRI

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age ≥ 18 years;
• no history of surgical treatment or radiotherapy;
• no contraindication to MRI scanning;
• agreeable to receive the fMRI scanning and awake craniotomy with DCS

You may not qualify if:

• basing on the anatomic MRI, the distance from the tumor to the hand-knob area lower than 20 mm;
• disable to finish the task of clenching fist during fMRI scanning.

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100005, China

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Tao Jiang, MD and Ph.D

CONTACT

+86-010-67021832; taojiang1964@163.com

Shengyu Fang, MD

CONTACT

+8613466331405

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 12, 2022
• Study Start: February 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)