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 28, 2019
Last Update Posted : June 24, 2022
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Condition or disease | Intervention/treatment | Phase |
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Brain Mass Glioma | Procedure: Functional Magnetic Resonance Imaging Procedure: Magnetic Resonance Imaging Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging | Not Applicable |
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.
Study Type : | Interventional |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Resting-State Functional MRI in Glioma Patients Before and After Surgery |
Actual Study Start Date : | April 24, 2017 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
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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.
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Procedure: Functional Magnetic Resonance Imaging
Undergo fMRI
Other Names:
Procedure: Magnetic Resonance Imaging Undergo CVR MRI
Other Names:
Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging Undergo rs-fMRI
Other Names:
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- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with newly diagnosed brain mass suspected to be gliomas
- Native 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 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
Exclusion Criteria:
- Patients with prior radiation or chemotherapy
- Patients cannot give informed consent
- Patients cannot undergo MRI and functional MRI examinations

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 hlaliu@mdanderson.org | |
Principal Investigator: Ho-Ling A. Liu |
Principal Investigator: | Ho-Ling A Liu | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT03964909 |
Other Study ID Numbers: |
2016-0906 NCI-2019-02653 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2016-0906 ( Other Identifier: M D Anderson Cancer Center ) |
First Posted: | May 28, 2019 Key Record Dates |
Last Update Posted: | June 24, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |