Assessment of Eloquent Function in Brain Tumor Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01535430
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Nebraska
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michele Aizenberg, MD
Principal Investigator Affiliation	University of Nebraska
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Brain Tumor, Metastatic Brain Tumor

Additional Details

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.

Arms & Interventions

Arms

: Eloquent area tumor

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

Interventions

Diagnostic Test: - Brain mapping

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Site Contact

Dulce Maroni, PhD

[email protected]

402-836-9751

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