Clinical trial NCT01535430: Assessment of Eloquent Function in Brain Tumor Patients
Official title: Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Brain Tumor
Metastatic Brain Tumor
Keywords: brain mapping
brain tumor
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a brain tumor in or near an area of eloquent brain function (speech, motor, sensory).

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.

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

Primary outcomes:
measure: Eloquent function
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Michele Aizenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.