ZOOMit-fMRI Identifies Motor Functional Cortex

NCT ID: NCT03091270

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-01

Study Completion Date

2025-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed to collect a series of patients with gliomas which were involved in motor cortex to analyze difference accuracy of motor cortex localization between BOLD-fMRI and ZOOMit-fMRI.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Gliomas will lead motor dysfunction when they are involved in motor cortex. However, tumor resection also have risk to lead postoperatively motor function deficits if destroy patients' motor cortex when tumor removed. Hence, it is important for neurosurgeon to realize the situation of patients' motor cortex locations in order to determine personal operative protocol.

The blood oxygen level dependent fMRI (BOLD-fMRI) is a prevalent preoperative method to localization motor cortex. It shows motor relevant cortex by the change of blood oxygen level when patients cooperate to finish motor 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 motor functional cortex.The advantage of ZOOMit-fMRI is smaller field of view (FOV) and higher spatial resolution comparing with BOLD-fMRI. That 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 motor cortex, to acquire their BOLD-fMRI and ZOOMit-fMRI data in order to analyze their difference in the accuracy of motor cortex localization.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gliomas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BOLD-fMRI

Identifying the motor functional cortex in glioma patients with BOLD-fMRI.

No interventions assigned to this group

ZOOMit-fMRI

Identifying the motor functional cortex in glioma patients with ZOOMit-fMRI.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

The inclusion criteria were as follows: 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.

The exclusion criteria were as follows: 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

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Neurosurgical Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tao Jiang, MD and PhD

Role: CONTACT

+86-010-67021832

Shengyu Fang, MD

Role: CONTACT

+8613466331405

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tao Jiang, MD and PhD

Role: primary

+86-010-67021832

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NSFC-81601452

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.