Recruiting

Observational Study

Sponsor:

University of Nebraska

Code:

NCT01535430

Conditions

Primary Brain Tumor

Metastatic Brain Tumor

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Brain mapping

Study Details

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.

Conditions

Primary Brain Tumor

Metastatic Brain Tumor

Study ID

NCT01535430

Start date

Jan 31, 2012

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Eloquent area tumor

Standard of care with brain mapping, pre-, intra-, and post-operative.

Interventions

Brain mapping

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

Primary outcome measure

  • Eloquent function [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Dulce Maroni, PhD

402-836-9751dmaroni@unmc.edu

Katie Maire, MS

402-559-6895kmaire@unmc.edu

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Dulce Maroni, PhD

402-836-9751dmaroni@unmc.edu

Katie Maire, MS

402-559-6895kmaire@unmc.edu

Principal Investigator:

Michele Aizenberg, MD

More Information

Sponsor

University of Nebraska

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • brain mapping
  • brain tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-01-13.