Assessment of Eloquent Function in Brain Tumor Patients

University of Nebraska

Status

Enrolling

Conditions

Metastatic Brain Tumor

Primary Brain Tumor

Treatments

Diagnostic Test: Brain mapping

Study type

Observational

Funder types

Other

Identifiers

NCT01535430

0671-11-FB

0240-24-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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