Assessment of Eloquent Function in Brain Tumor Patients

Trial Title: Assessment of Eloquent Function in Brain Tumor Patients

NCT ID: NCT01535430

Condition: Primary Brain Tumor
Metastatic Brain Tumor

Conditions: Official terms:
Neoplasms
Brain Neoplasms

Conditions: Keywords:
brain mapping
brain tumor

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Brain mapping
Description: Brain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.
Arm group label: Eloquent area tumor

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.

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.

Criteria for eligibility:

Study pop:
Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Nebraska Medical Center

Address:
City: Omaha
Zip: 68198
Country: United States

Status: Recruiting

Contact:
Last name: Dulce Maroni, PhD

Phone: 402-836-9751
Email: dmaroni@unmc.edu

Contact backup:
Last name: Katie Maire, MS

Phone: 402-559-6895
Email: kmaire@unmc.edu

Investigator:
Last name: Michele Aizenberg, MD
Email: Principal Investigator

Start date: January 31, 2012

Completion date: December 2025

Lead sponsor:
Agency: University of Nebraska
Agency class: Other

Source: University of Nebraska

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01535430