Assessment of Eloquent Function in Brain Tumor Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Brain Tumor; Metastatic Brain Tumor
• Intervention / Treatment: Diagnostic test: Brain mapping

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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Katie Maire, MS; Phone Number: 402-559-6895; Email: kmaire@unmc.edu
• Study Contact Backup: Name: Dulce Maroni, PhD; Phone Number: 402-836-9751; Email: dmaroni@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Katie Maire, MS; Phone Number: 402-559-6895; Email: kmaire@unmc.edu
      • Principal Investigator: Michele Aizenberg, MD
      • Contact: Dulce Maroni, PhD; Phone Number: 402-836-9751; Email: dmaroni@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eloquent area tumor; Standard of care with brain mapping, pre-, intra-, and post-operative.	Diagnostic test: Brain mapping; Brain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eloquent function	The location of the eloquent function of interest (motor, sensory, speech) will be assessed pre-operatively and intra-operatively. These will be compared. Then, at 2 and 6 months post-operatively, repeat non-invasive mapping studies will be performed to compare to the subjects' prior studies. This will allow for assessment of reorganization and plasticity of function. Addtionally, novel ways of identifying eloquent brain regions will be developed.	1 year

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Michele Aizenberg, MD, University of Nebraska

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2012
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 8, 2012
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (Estimated): February 17, 2012

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: brain tumor; brain mapping
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 0671-11-FB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No