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Assessment of Eloquent Function in Brain Tumor Patients
Conditions
Primary Brain Tumor - Metastatic Brain Tumor
Conditions: official terms
Brain Neoplasms - Neoplasms
Conditions: Keywords
brain mapping, brain tumor
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
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.
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, 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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: 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.
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.
Location
University of Nebraska Medical Center
Omaha, Nebraska, United States
Status: Recruiting
Contact: Michele Aizenberg, MD - 402-559-9614 - maizenberg@unmc.edu
Start Date
January 2012
Completion Date
December 2015
Sponsors
University of Nebraska
Source
University of Nebraska
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page