Resting-State Functional MRI in Glioma Patients Before and After Surgery

NCT ID: NCT03964909

Last Updated: 2024-11-15

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2024-11-12

Brief Summary

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This clinical trial studies how well resting-state functional magnetic resonance imaging (MRI) and cerebrovascular reactivity (CVR) MRI performed before and after surgery works in measuring the effects on language in patients with glioma. Mapping language function before brain tumor resection is crucial for preventing post-surgical deficits and maximizing restoration of language function following surgery. Additional imaging, such as resting-state functional MRI and CVR MRI, may help measure the language network in the brain before surgery and any effects on language function after surgery.

Detailed Description

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PRIMARY OBJECTIVES:

I. To develop a reliable platform for preoperative mapping of language networks using resting-state-functional magnetic resonance imaging (rs)-fMRI in glioma patients.

SECONDARY OBJECTIVES:

I. To explore the reorganizations of resting-state functional connectivity (FC) and their relation to neuropsychological outcomes in glioma patients after surgery.

OUTLINE:

Patients undergo standard of care functional (f)MRI, CVR MRI over 3 minutes, and rs-fMRI over 6 minutes 1 month before and within 6 weeks after standard of care surgery.

After completion of study, patients are followed up at 4-6 weeks.

Conditions

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Brain Mass Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (fMRI, CVR MRI, rs-fMRI)

Patients undergo standard of care fMRI, CVR MRI over 3 minutes, and rs-fMRI over 6 minutes 1 month before and within 6 weeks after standard of care surgery.

Group Type EXPERIMENTAL

Functional Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo fMRI

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo CVR MRI

Resting State Functional Connectivity Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo rs-fMRI

Interventions

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Functional Magnetic Resonance Imaging

Undergo fMRI

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo CVR MRI

Intervention Type PROCEDURE

Resting State Functional Connectivity Magnetic Resonance Imaging

Undergo rs-fMRI

Intervention Type PROCEDURE

Other Intervention Names

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fMRI Functional MRI Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Resting fcMRI Resting State Functional Connectivity MRI RS-fcMRI

Eligibility Criteria

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Inclusion Criteria

* Patients with newly diagnosed brain mass suspected to be gliomas
* English speaker
* Right handed
* Tumor is located on or adjacent to Broca's or Wernicke's areas in the hemisphere suspected to be dominant for language
* No prior history of neurologic disease or insult, or neuropsychiatric illness requiring treatment that would affect cognition in the opinion of the attending neuropsychologist
* Patients who will undergo neurosurgical resection
* Patients who are on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care
* Patients who will complete pre- and postoperative neuropsychological testing per standard of care
* Pregnant women

Exclusion Criteria

* Patients with prior radiation or chemotherapy
* Patients cannot give informed consent
* Patients cannot undergo MRI and functional MRI examinations
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Ling A Liu

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2019-02653

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-0906

Identifier Type: OTHER

Identifier Source: secondary_id

2016-0906

Identifier Type: -

Identifier Source: org_study_id

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