Evaluation of Changes in Brain Connectivity After Tumor Resection

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.

Study Overview

• Status: Completed
• Conditions: Brain Tumor
• Intervention / Treatment: Diagnostic test: MRI; Diagnostic test: neuropsychological tests and qualitative assessment

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).

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Unversity of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects	Diagnostic test: MRI; A research MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery. The surgical removal of the brain tumor(s) is not a component of this research. The MRI scan will perform both programs (diffusion MRI, resting state MRI) during the same single session. The healthy controls will obtain identical research scans with the second session between two and three weeks following the first session, since they will not undergo a surgery.; Diagnostic test: neuropsychological tests and qualitative assessment; Neuropsych Tests: COWA, Trails, RCFT, RAVLT, WMS-III subtests, NAB Digits, Grooved Pegboard, Stroop Color Word Test, verbal and spatial working memory, WRAT-IV, Word Reading subtest. Standardized quality of life measures: MDASI-BT, FACT-Br, FrSBe
Brain tumors; Subjects with operable supratentorial brain tumors	Diagnostic test: MRI; A research MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery. The surgical removal of the brain tumor(s) is not a component of this research. The MRI scan will perform both programs (diffusion MRI, resting state MRI) during the same single session. The healthy controls will obtain identical research scans with the second session between two and three weeks following the first session, since they will not undergo a surgery.; Diagnostic test: neuropsychological tests and qualitative assessment; Neuropsych Tests: COWA, Trails, RCFT, RAVLT, WMS-III subtests, NAB Digits, Grooved Pegboard, Stroop Color Word Test, verbal and spatial working memory, WRAT-IV, Word Reading subtest. Standardized quality of life measures: MDASI-BT, FACT-Br, FrSBe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain connectivity changes	With both the functional and structural connectomes created, the investigators will compute graph network measures before and after surgical resection and assess both nodal and global network measures.	MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery.
Neurocognitive changes	Meyers Neuropsychological Battery: Published reliable change indices (RCI) will be used to control for practice effects between the assessment points for all Meyers Neuropsychological Battery (MNB) subtests. QOL inventories: Differences in scores at baseline, relative to treatment phase, will be calculated.	Cognitive tests will be performed within 1 week prior to surgery and again 2 weeks after surgery.

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: Great Plains IDeA-CTR
• Investigators: Principal Investigator: Michele Aizenberg, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Actual): June 6, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 0155-20-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No