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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03964909
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ho-Ling A Liu
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Mass, Glioma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Procedure: - Functional Magnetic Resonance Imaging

Undergo fMRI

Procedure: - Magnetic Resonance Imaging

Undergo CVR MRI

Procedure: - Resting State Functional Connectivity Magnetic Resonance Imaging

Undergo rs-fMRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Ho-Ling A. Liu

[email protected]

713-563-7383

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