Primary Brain TumorNCT01535430
Assessment of Eloquent Function in Brain Tumor Patients
An observational study of Primary Brain Tumor and Metastatic Brain Tumor, run by University of Nebraska at 1 site in United States.
Trial summary
Purpose of the study: AIM 1: Prospectively collect pre-operative [functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), magnetoencephalography (MEG)] and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Brain Tumor, Metastatic Brain Tumor
- What is being tested?
- Brain mapping
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2012to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).
Who may be able to join
- 19 years and older
- Brain tumor in or near eloquent brain regions that is appropriate for attempted resection
- Appropriate body habitus and mental status/capacity to participate with non-invasive or invasive mapping
- Benign or malignant intra-axial brain tumor
- Primary or metastatic intra-axial brain tumor
Who cannot join
- Any contraindication to MRI (i.e. implanted devices)
- Inappropriate body habitus or mental status/capacity to participate with non-invasive or invasive mapping in a safe and reliable manner
- Declining to participate
- Lacks capacity to understand the study or consent for themselves
- Neurologic status which precludes testing (poor function- not testable)
- Positive pregnancy test
- End stage renal disease or severe renal dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Dulce Maroni, PhD, 402-836-9751, dmaroni@unmc.edu
Katie Maire, MS, 402-559-6895, kmaire@unmc.edu
About this study
Official title: Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
Purpose of the study:
AIM 1: Prospectively collect pre-operative [functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), magnetoencephalography (MEG)] and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent brain function. In addition, each modality will be compared with the other.
AIM 2: Assess reorganization of eloquent brain function and plasticity in patients with intra-axial brain tumors. This will be accomplished by prospectively collecting post-operative mapping studies and neuropsychological tests to compare them to prior mapping studies as stated above.
Read the detailed description
Any patient with a primary or metastatic brain tumor in or near an eloquent area would be eligible for participation in the study assuming no contraindications to any of the studies or operative procedure.
Pre-operative evaluation will include clinical evaluation, neuropsychological testing, magnetic resonance imaging (MRI) brain with and without contrast, fMRI, DTI tractograms, and MEG studies as well as standard pre-operative work-up.
Intra-operative procedures include all non-invasive pre-operative mapping data being incorporated into the operative procedure with imaging tools that are routinely used during neurosurgical procedures. Participants will have awake mapping performed. Usual standards of care will be followed during craniotomy, mapping, and tumor resection or biopsy.
Post-operative procedures include routine post-operative care and assessment consisting of clinical examinations and imaging obtained within 24 hours post-resection. Participants will have routine follow-up outpatient appointments after surgery which will include neurologic assessment and follow-up imaging (MRI with and without contrast) for their tumors as appropriate. The experimental portion of the protocol is incorporating repeat neuropsychological testing and mapping studies (fMRI, DTI, MEG) studies at 2 and 6 months post-surgery into their routine follow-up.
- Conditions
- Primary Brain Tumor, Metastatic Brain Tumor
- Being tested
- Brain mapping
- Keywords
- brain mapping, brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain mappingDiagnostic test
Brain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.
| Study group | Role | What they receive |
|---|---|---|
| Eloquent area tumor | Standard of care with brain mapping, pre-, intra-, and post-operative. Receives: Diagnostic Test: Brain mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eloquent function
The location of the eloquent function of interest (motor, sensory, speech) will be assessed pre-operatively and intra-operatively and compared. Then, at 2 and 6 months post-operatively, repeat non-invasive mapping studies will be performed to compare to the subjects' prior studies. This will allow for assessment of reorganization and plasticity of function. Additionally, novel ways of identifying eloquent brain regions will be developed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study start31 Jan 2012
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Aizenberg, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535430
- Sponsor's protocol ID
- 0240-24-FB
- Other IDs
- 0671-11-FB
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2012
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ellis DG, White ML, Hayasaka S, Warren DE, Wilson TW, Aizenberg MR. Accuracy analysis of fMRI and MEG activations determined by intraoperative mapping. Neurosurg Focus. 2020 Feb 1;48(2):E13. doi: 10.3171/2019.11.FOCUS19784.
PubMed 32006951
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT01535430
- Acronym / sponsor ID
- 0240-24-FB
- Conditions
- Primary Brain Tumor, Metastatic Brain Tumor
- Keywords
- brain mapping, brain tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 31 Jan 2012 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Feb 2012 (estimated)
- 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.
Purpose of the study:
AIM 1: Prospectively collect pre-operative [functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), magnetoencephalography (MEG)] and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent brain function. In addition, each modality will be compared with the other.
AIM 2: Assess reorganization of eloquent brain function and plasticity in patients with intra-axial brain tumors. This will be accomplished by prospectively collecting post-operative mapping studies and neuropsychological tests to compare them to prior mapping studies as stated above.
Detailed description
Any patient with a primary or metastatic brain tumor in or near an eloquent area would be eligible for participation in the study assuming no contraindications to any of the studies or operative procedure.
Pre-operative evaluation will include clinical evaluation, neuropsychological testing, magnetic resonance imaging (MRI) brain with and without contrast, fMRI, DTI tractograms, and MEG studies as well as standard pre-operative work-up.
Intra-operative procedures include all non-invasive pre-operative mapping data being incorporated into the operative procedure with imaging tools that are routinely used during neurosurgical procedures. Participants will have awake mapping performed. Usual standards of care will be followed during craniotomy, mapping, and tumor resection or biopsy.
Post-operative procedures include routine post-operative care and assessment consisting of clinical examinations and imaging obtained within 24 hours post-resection. Participants will have routine follow-up outpatient appointments after surgery which will include neurologic assessment and follow-up imaging (MRI with and without contrast) for their tumors as appropriate. The experimental portion of the protocol is incorporating repeat neuropsychological testing and mapping studies (fMRI, DTI, MEG) studies at 2 and 6 months post-surgery into their routine follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eloquent area tumor | – | Diagnostic Test: Brain mappingStandard of care with brain mapping, pre-, intra-, and post-operative. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).
Key inclusion criteria (5 listed)
- 19 years and older
- Brain tumor in or near eloquent brain regions that is appropriate for attempted resection
- Appropriate body habitus and mental status/capacity to participate with non-invasive or invasive mapping
- Benign or malignant intra-axial brain tumor
- Primary or metastatic intra-axial brain tumor
Key exclusion criteria (7 listed)
- Any contraindication to MRI (i.e. implanted devices)
- Inappropriate body habitus or mental status/capacity to participate with non-invasive or invasive mapping in a safe and reliable manner
- Declining to participate
- Lacks capacity to understand the study or consent for themselves
- Neurologic status which precludes testing (poor function- not testable)
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 |
|---|---|---|
| Brain mappingBrain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions. | Diagnostic test | Eloquent area tumor |
Primary outcome
Eloquent function
Time frame: 1 year
The location of the eloquent function of interest (motor, sensory, speech) will be assessed pre-operatively and intra-operatively and compared. Then, at 2 and 6 months post-operatively, repeat non-invasive mapping studies will be performed to compare to the subjects' prior studies. This will allow for assessment of reorganization and plasticity of function. Additionally, novel ways of identifying eloquent brain regions will be developed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Derived from this study: PubMed 32006951Ellis DG, White ML, Hayasaka S, Warren DE, Wilson TW, Aizenberg MR. Accuracy analysis of fMRI and MEG activations determined by intraoperative mapping. Neurosurg Focus. 2020 Feb 1;48(2):E13. doi: 10.3171/2019.11.FOCUS19784.
- Individual participant dataSharing planned: No
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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.
Michele Aizenberg, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Brain Tumor and Metastatic Brain Tumor, run by University of Nebraska 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dulce Maroni, PhD (402-836-9751, dmaroni@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eloquent function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01535430, which also lists 1 linked publication.
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 13 Jan 2026.