We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Changes in Brain Connectivity After Tumor Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 27, 2020
First Posted Date September 2, 2020
Last Update Posted Date October 3, 2022
Actual Study Start Date August 27, 2020
Estimated Primary Completion Date March 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: August 27, 2020)
  • 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, we will compute graph network measures before and after surgical resection. We will assess both nodal and global network measures.
  • 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Changes in Brain Connectivity After Tumor Resection
Official Title Evaluation of Changes in Brain Connectivity After Tumor Resection
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).
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Brain Tumor
Intervention
  • 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

Study Groups/Cohorts
  • Brain tumors
    Subjects with operable supratentorial brain tumors
    Interventions:
    • Diagnostic Test: MRI
    • Diagnostic Test: neuropsychological tests and qualitative assessment
  • Healthy subjects
    Healthy subjects
    Interventions:
    • Diagnostic Test: MRI
    • Diagnostic Test: neuropsychological tests and qualitative assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 27, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 30, 2023
Estimated Primary Completion Date March 30, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Dulce Maroni, PhD 402.836.9751 dmaroni@unmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04536142
Other Study ID Numbers 155-20-EP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Michele Aizenberg, MD, University of Nebraska
Original Responsible Party Same as current
Current Study Sponsor University of Nebraska
Original Study Sponsor Same as current
Collaborators Great Plains IDeA-CTR
Investigators
Principal Investigator: Michele Aizenberg, MD University of Nebraska
PRS Account University of Nebraska
Verification Date September 2022