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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03964909
Enrollment
29
Registered
2019-05-28
Start date
2017-04-24
Completion date
2024-11-12
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Mass, Glioma

Brief summary

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

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.

Interventions

PROCEDUREFunctional Magnetic Resonance Imaging

Undergo fMRI

PROCEDUREMagnetic Resonance Imaging

Undergo CVR MRI

PROCEDUREResting State Functional Connectivity Magnetic Resonance Imaging

Undergo rs-fMRI

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detectability of language networksUp to 6 weeksWill be performed using resting-state-functional magnetic resonance imaging (rs-fMRI). The receiver operating characteristic (ROC) analysis will be carried out to compare the difference between the diagnostic performance of the proposed method and that of the data-driven rs-fMRI method. The study will evaluate the performance of rs-fMRI by comparing with the standard of care intraoperative direct cortical stimulation.

Secondary

MeasureTime frameDescription
Changes in resting-state functional connectivity and neuropsychological outcomesUp to 6 weeksGraph theoretical analysis and large-scale network analysis will be applied to analyze pre- and post- surgical rs-fMRI data, to explore how the functional reorganization is correlated to the changes of neuropsychological scores. Correlational analyses will be conducted to determine the associations between changes in rs-fMRI network features and neuropsychological functioning from the pre- to postoperative period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026