Resting-State Functional MRI in Glioma Patients Before and After Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03964909|
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : May 27, 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 (Clinical Trial)|
|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 :||October 24, 2019|
|Estimated Study Completion Date :||October 24, 2019|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 email@example.com|
|Principal Investigator: Ho-Ling A. Liu|
|Principal Investigator:||Ho-Ling A Liu||M.D. Anderson Cancer Center|