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Evaluation of Changes in Brain Connectivity After Tumor Resection

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ClinicalTrials.gov Identifier: NCT04536142
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : October 3, 2022
Sponsor:
Collaborator:
Great Plains IDeA-CTR
Information provided by (Responsible Party):
Michele Aizenberg, MD, University of Nebraska

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.

Condition or disease Intervention/treatment
Brain Tumor 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).

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Changes in Brain Connectivity After Tumor Resection
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Group/Cohort Intervention/treatment
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


Healthy subjects
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





Primary Outcome Measures :
  1. Brain connectivity changes [ Time Frame: MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery. ]
    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.

  2. Neurocognitive changes [ Time Frame: Cognitive tests will be performed within 1 week prior to surgery and again 2 weeks after surgery. ]

    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.




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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536142


Contacts
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Contact: Dulce Maroni, PhD 402.836.9751 dmaroni@unmc.edu

Locations
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United States, Nebraska
UNMC/Nebraska Medicine Recruiting
Omaha, Nebraska, United States, 68198
Contact: Dulce Maroni, PhD    402-836-9751    dmaroni@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Great Plains IDeA-CTR
Investigators
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Principal Investigator: Michele Aizenberg, MD University of Nebraska
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Responsible Party: Michele Aizenberg, MD, Professor, Neurosurgery, Director Brain and Spine Cancer Center, University of Nebraska
ClinicalTrials.gov Identifier: NCT04536142    
Other Study ID Numbers: 155-20-EP
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases