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出境医 / 临床实验 / Resting-State Functional MRI in Glioma Patients Before and After Surgery
Resting-State Functional MRI in Glioma Patients Before and After Surgery
Study Description
Brief Summary:
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.
| 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 |
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 Design
| Study Type : | Interventional (Clinical Trial) |
| 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 : | May 12, 2021 |
| Estimated Study Completion Date : | May 12, 2022 |
Arms and Interventions
| 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.
|
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:
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Locations
| 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 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Ho-Ling A Liu | M.D. Anderson Cancer Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 23, 2019 | ||||
| First Posted Date ICMJE | May 28, 2019 | ||||
| Last Update Posted Date | January 15, 2021 | ||||
| Actual Study Start Date ICMJE | April 24, 2017 | ||||
| Estimated Primary Completion Date | May 12, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Resting-State Functional MRI in Glioma Patients Before and After Surgery | ||||
| Official Title ICMJE | Resting-State Functional MRI in Glioma Patients Before and After Surgery | ||||
| Brief Summary | 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. | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | 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.
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
30 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 12, 2022 | ||||
| Estimated Primary Completion Date | May 12, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | |||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03964909 | ||||
| Other Study ID Numbers ICMJE | 2016-0906 NCI-2019-02653 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2016-0906 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| PRS Account | M.D. Anderson Cancer Center | ||||
| Verification Date | January 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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