Glioma Clinical Trial
Official title:
Resting-State Functional MRI in Glioma Patients Before and After Surgery
Verified date | April 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detectability of language networks | Will 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. | Up to 6 weeks | |
Secondary | Changes in resting-state functional connectivity and neuropsychological outcomes | Graph 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. | Up to 6 weeks |
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