Evaluation of Changes in Brain Connectivity After Tumor Resection

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    30
  • sponsor
    University of Nebraska
Updated on 29 October 2022
Accepts healthy volunteers

Summary

This study is being done to see the changes in structural and functional connectivity that happen in the brain of patients undergoing brain tumor surgery.

Description

The purpose of this study is to visualize and quantify changes in the brain of patients undergoing brain tumor surgery through high-quality, high-resolution structural and functional brain imaging and brain connectivity measures. To understand the effects of the primary treatment for brain tumors, the investigators will determine changes in brain connectivity after surgery and correlate this with neurologic status. The investigators will prospectively collect brain imaging (MRI) and clinical data in brain tumor patients before and after removal of their tumor. Any adult patient with a brain tumor (primary or metastatic) for whom surgery to remove the tumor is planned is eligible. The investigators plan for recruitment of 30 subjects. This will include 27 subjects with brain tumors and 3 healthy controls. Both clinical and imaging data will be collected for tumor and healthy subjects. A two-part research scan (diffusion MRI and resting state functional MRI) will be performed within 1 week prior to surgery and again 2 weeks after surgery. The healthy controls will obtain identical research scans with the second session two weeks following the first session. Subjects will be also administered Neurocognitive and Qualitative Assessments at two time intervals, pre- and post-surgery (2 weeks).

Details
Condition Brain Tumor
Treatment MRI, neuropsychological tests and qualitative assessment
Clinical Study IdentifierNCT04536142
SponsorUniversity of Nebraska
Last Modified on29 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Brain tumor subjects (27)
informed consent
age equal to or greater than 19 years (age of majority in Nebraska)
brain tumor that requires surgery
primary or metastatic brain tumor
Healthy subjects (3)
informed consent
age equal to or greater than 19 years (age of majority in Nebraska)
healthy subject with no know neurocognitive deficiencies

Exclusion Criteria

any contraindication to MRI (i.e. implanted devices)
inappropriate body habitus for MRI
no capacity to understand the study the study or consent to it
positive pregnancy test in females
end stage renal disease or severe renal dysfunction
severe anxiety disorder
metabolic encephalopathy
significant medical co-morbidities precluding a safe surgery
need for sedation for MRI
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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