Clinical trial NCT04536142: Evaluation of Changes in Brain Connectivity After Tumor Resection
Official title: Evaluation of Changes in Brain Connectivity After Tumor Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Great Plains IDeA-CTR
First posted: 2020-09-02
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncologists and neurosurgeons may identify their patients for potential inclusion as brain tumor subjects. The "word-of-mouth" approach will be used to identify potential healthy subjects for this study.

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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

Primary outcomes:
measure: Brain connectivity changes
timeFrame: MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery.
measure: Neurocognitive changes
timeFrame: Cognitive tests will be performed within 1 week prior to surgery and again 2 weeks after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Michele Aizenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: