- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03964909
Resting-State Functional MRI in Glioma Patients Before and After Surgery
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Ho-Ling A. Liu
- Phone Number: 713-563-7383
- Email: hlaliu@mdanderson.org
-
Principal Investigator:
- Ho-Ling A. Liu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Undergo fMRI
Other Names:
Undergo CVR MRI
Other Names:
Undergo rs-fMRI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ho-Ling A Liu, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0906 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-02653 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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