Brain TumorNCT04536142
Evaluation of Changes in Brain Connectivity After Tumor Resection
An observational study of Brain Tumor, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor
- What is being tested?
- MRI and neuropsychological tests and qualitative assessment
- Type of treatment
- Injection or infusion
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2020to 6 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- informed consent
- age equal to or greater than 19 years (age of majority in Nebraska)
- healthy subject with no know neurocognitive deficiencies
Who cannot join
- 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
Show all 9Show fewer
- metabolic encephalopathy
- significant medical co-morbidities precluding a safe surgery
- need for sedation for MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the 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).
- Conditions
- Brain Tumor
- Being tested
- MRI, neuropsychological tests and qualitative assessment
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
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.
neuropsychological tests and qualitative assessmentDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Brain tumors | Subjects with operable supratentorial brain tumors Receives: Diagnostic Test: MRI; Diagnostic Test: neuropsychological tests and qualitative assessment | |
| Healthy subjects | Healthy subjects Receives: Diagnostic Test: MRI; Diagnostic Test: neuropsychological tests and qualitative assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Cognitive tests will be performed within 1 week prior to surgery and again 2 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start27 Aug 2020
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Great Plains IDeA-CTR
- Responsible party
- Sponsor
- Investigators
- Michele Aizenberg, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536142
- Sponsor's protocol ID
- 0155-20-EP
- Status last verified
- Sep 2023
- First submitted
- 27 Aug 2020
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Brain Connectivity After Tumor Resection
- ClinicalTrials.gov ID
- NCT04536142
- Acronym / sponsor ID
- 0155-20-EP
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Great Plains IDeA-CTR
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain tumors | – | Diagnostic Test: MRI, Diagnostic Test: neuropsychological tests and qualitative assessmentSubjects with operable supratentorial brain tumors |
| Healthy subjects | – | Diagnostic Test: MRI, Diagnostic Test: neuropsychological tests and qualitative assessmentHealthy subjects |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Brain tumor subjects (27)
- Healthy subjects (3)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIA 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 | Brain tumors, Healthy subjects |
| neuropsychological tests and qualitative assessmentNeuropsych 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 | Diagnostic test | Brain tumors, Healthy subjects |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Aizenberg, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain connectivity changes (time frame: MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.