Brain MassNCT03964909
Resting-State Functional MRI in Glioma Patients Before and After Surgery
A study testing Functional Magnetic Resonance Imaging, Magnetic Resonance Imaging and Resting State Functional Connectivity Magnetic Resonance Imaging in people with Brain Mass and Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Mass, Glioma
- What is being tested?
- Functional Magnetic Resonance Imaging, Magnetic Resonance Imaging and Resting State Functional Connectivity Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Patients with prior radiation or chemotherapy
- Patients cannot give informed consent
- Patients cannot undergo MRI and functional MRI examinations
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Brain Mass, Glioma
- Being tested
- Functional Magnetic Resonance Imaging, Magnetic Resonance Imaging, Resting State Functional Connectivity Magnetic Resonance Imaging
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance ImagingProcedure or surgery
Also called fMRI, Functional MRI
Undergo fMRI
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo CVR MRI
Resting State Functional Connectivity Magnetic Resonance ImagingProcedure or surgery
Also called Resting fcMRI, Resting State Functional Connectivity MRI, RS-fcMRI
Undergo rs-fMRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (fMRI, CVR MRI, rs-fMRI) | Experimental | 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. Receives: Procedure: Functional Magnetic Resonance Imaging; Procedure: Magnetic Resonance Imaging; Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detectability of language networks
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.
Measured: Up to 6 weeks
Secondary outcomes (1)
Changes in resting-state functional connectivity and neuropsychological outcomes
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.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start24 Apr 2017
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MassStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ho-Ling A Liu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964909
- Sponsor's protocol ID
- 2016-0906
- Other IDs
- NCI-2019-02653, 2016-0906
- Status last verified
- Nov 2024
- First submitted
- 23 May 2019
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting-State Functional MRI in Glioma Patients Before and After Surgery
- ClinicalTrials.gov ID
- NCT03964909
- Acronym / sponsor ID
- 2016-0906
- Conditions
- Brain Mass, Glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (fMRI, CVR MRI, rs-fMRI) | Experimental | Procedure: Functional Magnetic Resonance Imaging, Procedure: Magnetic Resonance Imaging, Procedure: Resting State Functional Connectivity Magnetic Resonance ImagingPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with prior radiation or chemotherapy
- Patients cannot give informed consent
- Patients cannot undergo MRI and functional MRI examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic Resonance ImagingAlso: fMRI, Functional MRIUndergo fMRI | Procedure or surgery | Diagnostic (fMRI, CVR MRI, rs-fMRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo CVR MRI | Procedure or surgery | Diagnostic (fMRI, CVR MRI, rs-fMRI) |
| Resting State Functional Connectivity Magnetic Resonance ImagingAlso: Resting fcMRI, Resting State Functional Connectivity MRI, RS-fcMRIUndergo rs-fMRI | Procedure or surgery | Diagnostic (fMRI, CVR MRI, rs-fMRI) |
Primary outcome
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.
1 secondary outcome
Changes in resting-state functional connectivity and neuropsychological outcomes
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Ling A Liu principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Resonance Imaging, Magnetic Resonance Imaging and Resting State Functional Connectivity Magnetic Resonance Imaging in people with Brain Mass and Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detectability of language networks (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.