Resting-State Functional MRI in Glioma Patients Before and After Surgery
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|ClinicalTrials.gov Identifier: NCT03964909|
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Mass Glioma||Procedure: Functional Magnetic Resonance Imaging Procedure: Magnetic Resonance Imaging Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging||Not Applicable|
I. To develop a reliable platform for preoperative mapping of language networks using resting-state-functional magnetic resonance imaging (rs)-fMRI in glioma patients.
I. To explore the reorganizations of resting-state functional connectivity (FC) and their relation to neuropsychological outcomes in glioma patients after surgery.
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.
|Study Type :||Interventional|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Resting-State Functional MRI in Glioma Patients Before and After Surgery|
|Actual Study Start Date :||April 24, 2017|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
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.
Procedure: Functional Magnetic Resonance Imaging
Procedure: Magnetic Resonance Imaging
Undergo CVR MRI
Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging
- Detectability of language networks [ Time Frame: Up to 6 weeks ]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.
- Changes in resting-state functional connectivity and neuropsychological outcomes [ Time Frame: Up to 6 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964909
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ho-Ling A. Liu 713-563-7383 firstname.lastname@example.org|
|Principal Investigator: Ho-Ling A. Liu|
|Principal Investigator:||Ho-Ling A Liu||M.D. Anderson Cancer Center|