Assessment of Eloquent Function in Brain Tumor Patients

Primary Brain Tumor Clinical Trial

Official title:

Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01535430
• Other study ID #: 0240-24-FB
• Status: Recruiting
• Start date: January 31, 2012
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of Nebraska
• Contact: Dulce Maroni, PhD
• Phone: 402-836-9751
• Email: dmaroni[@]unmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Metastatic Brain Tumor
• Neoplasms
• Primary Brain Tumor

Intervention

Diagnostic Test:
• Brain mapping
Brain mapping will be employed pre-, intra-, and post-operatively to evaluate specific functions.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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