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ZOOMit-fMRI Identifies Language Functional Cortex

Sponsor
Beijing Neurosurgical Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05188534
Collaborator
(none)
60
Enrollment
1
Location
10.9
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    The Application of ZOOMit-fMRI to Identify Language Functional Cortex
    Anticipated Study Start Date :
    Feb 1, 2022
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. The accurate rate for language related cortex localization with BOLD-fMRI and ZOOMit-fMRI [From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Neurosurgical Institute and Beijing Tiantan Hospital Beijing Beijing China 100005

    Sponsors and Collaborators

    • Beijing Neurosurgical Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Neurosurgical Institute
    ClinicalTrials.gov Identifier:
    NCT05188534
    Other Study ID Numbers:
    • KYSB2016-026
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Beijing Neurosurgical Institute
    Language functional cortex
    ZOOMit-fMRI

    Study Results

    No Results Posted as of Jan 12, 2022