Assessment of Eloquent Function in Brain Tumor Patients

NCT ID: NCT01535430

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2027-12-31

Brief 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 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.

Conditions

Primary Brain Tumor; Metastatic Brain Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Eloquent area tumor

Standard of care with brain mapping, pre-, intra-, and post-operative.

Brain mapping

Intervention Type: DIAGNOSTIC_TEST

Brain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.

Interventions

Brain mapping

Brain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Aizenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dulce Maroni, PhD

Role: CONTACT

dmaroni@unmc.edu

402-836-9751

Katie Maire, MS

Role: CONTACT

kmaire@unmc.edu

402-559-6895

Facility Contacts

Dulce Maroni, PhD

Role: primary

dmaroni@unmc.edu

402-836-9751

Katie Maire, MS

Role: backup

kmaire@unmc.edu

402-559-6895

References

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.

Reference Type: DERIVED

PMID: 32006951 (View on PubMed)

Other Identifiers

0671-11-FB

Identifier Type: OTHER

Identifier Source: secondary_id

0240-24-FB

Identifier Type: -

Identifier Source: org_study_id