- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06470711
Mapping of Electrical Properties in the Brain
Mapping of Electrical Properties in the Brain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Optimize pulse sequence acquisitions for diffusion imaging on clinical MRI vendor systems.
II. Develop image-based MRI models (including diffusion-based MRI) that accurately depict the multi-regional electrical properties in the brain (e.g., resistivity, current) to inform of neural integrity and function (including white matter tract integrity) in diseased and non-diseased states.
III. Compare/correlate image-based MRI models (e.g., diffusion) with existing structural, physiologic, and functional MRI methods (e.g., tensor imaging, fMRI, DSC-MRI, etc).
IV. Further train image-based models/measurements with loco-regional benchmarks including (but not exclusive to) electrophysiologic monitoring, functional and structural tissue assays (from available biopsies), and correlative clinical features (e.g., histology, outcomes, treatment, etc).
OUTLINE: This is an observational study.
Participants complete a survey and undergo MRI on study.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Recruiting
- Mayo Clinic in Arizona
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Leland S. Hu, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aim 1: normal healthy volunteers
- Aim 2, 3, 4: participants included in IRB 16-002424, including those that have undergone surgical biopsy/resection for suspected or known glioma
Exclusion Criteria:
- Healthy volunteer unable to have an MRI
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational
Participants complete a survey and undergo MRI on study.
|
Non-interventional study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify diffusion MRI metrics [using conductivity tensor imaging (CTI)] that inform of regional electrical properties in the brain
Time Frame: Baseline
|
At least 4 normal white matter regions of the brain will be analyzed.
Fractional anisotropy (FA) and optimized diagnostic imaging (ODI) values will be compared to determine alignment within normal healthy white matter tracts (e.g.
cortical spinal tract, corpus callosum).
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leland S. Hu, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-003556 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2024-04689 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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