Assessment of Eloquent Function in Brain Tumor Patients



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:4/2/2016
Start Date:January 2012
End Date:December 2015
Contact:Michele Aizenberg, MD
Email:maizenberg@unmc.edu
Phone:402-559-9614

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Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

Purpose of the study:

AIM 1 Prospectively collect pre-operative (fMRI, DTI, 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.

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, MRI brain with and
without contrast, fMRI, DTI tractograms, and MEG studies as well as standard pre-operative
work-up.

Intra-operative:

All non-invasive pre-operative mapping data will be incorporated into the operative
procedure with the imaging tools that we routinely use during neurosurgical procedures.
Patients will have awake mapping performed. Our usual standards of care will be followed
during craniotomy, mapping, and tumor resection or biopsy.

Post-operative:

Patients will have routine post-operative care and assessment consisting of clinical
examinations and imaging obtained within 24 hours post resection. They 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.

Inclusion Criteria:

1. Patients 19 years and older.

2. Brain tumor in or near eloquent brain regions that is appropriate for attempted
resection.

3. Appropriate body habitus and mental status/capacity to participate with non-invasive
or invasive mapping.

4. Benign or malignant intra-axial brain tumor.

5. Primary or metastatic intra-axial brain tumor.

Exclusion Criteria:

1. Any patient with a contraindication to MRI (i.e. implanted devices)

2. Inappropriate body habitus or mental status/capacity to participate with non-invasive
or invasive mapping in a safe and reliable manner.

3. Patient declines to participate.

4. Patient that does not have the capacity to understand the study or consent for
themselves.

5. Neurologic status which precludes them from testing (poor function- not testable).

6. Positive pregnancy test in females.

7. Any patient with end stage renal disease or severe renal dysfunction.
We found this trial at
1
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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