Clinical trial NCT05188534: ZOOMit-fMRI Identifies Language Functional Cortex
Official title: The Application of ZOOMit-fMRI to Identify Language Functional Cortex
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Keywords: Language functional cortex
ZOOMit-fMRI
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: The accurate rate for language related cortex localization with BOLD-fMRI and ZOOMit-fMRI
timeFrame: From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
state: Beijing
Study officials:
References: