Assessment of Eloquent Function in Brain Tumor Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brain mapping.
- Who it may be relevant to
- Registry conditions: Primary Brain Tumor, Metastatic Brain Tumor. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
Overview
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.
Interventions
- Diagnostic test Brain mapping
Brain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.
Primary outcome measures
- Eloquent function [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Nebraska Medical Center — Omaha
Publications
- 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. PMID 32006951
Identifiers
NCT: NCT01535430 · 0240-24-FB · 0671-11-FB