- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07786233
Multi-Field-Strength MRI Brain Atlas Construction in Healthy Chinese Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective multi-field-strength neuroimaging study involving healthy Chinese adults. Eligible participants will undergo standardized brain MRI examinations at 0.55T, 1.5T, 3T, 5T, and 7T according to the study protocol.
MRI acquisitions include structural imaging, diffusion imaging, functional imaging, and quantitative imaging sequences where applicable. Images will undergo standardized preprocessing, registration, segmentation, and quantitative analysis. Multi-field-strength brain templates will be constructed, and anatomical and functional imaging characteristics will be compared across magnetic field strengths.
The study aims to establish normative multi-field-strength MRI reference data and brain atlases for healthy Chinese adults and to evaluate the consistency and field-strength-related differences in brain morphometry, cortical measurements, diffusion characteristics, functional connectivity, and other quantitative MRI parameters.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ziheng Zhou
- Phone Number: +86 18710574531
- Email: 173416171@qq.com
Study Locations
-
-
Shaanxi
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Xi'an, Shaanxi, China
- Recruiting
- Tangdu Hospital, Fourth Military Medical University
-
Contact:
- Shicao Li
- Phone Number: 029-84717761
- Email: tangduec@126.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 16 to 66 years. Voluntarily participates in the study and provides written informed consent. No contraindications to MRI examination and able to cooperate with and complete the MRI examinations.
Female participants must not be pregnant. No current or previous clinical diagnosis of severe neurological or psychiatric disorders, such as schizophrenia, dementia, epilepsy, or severe sequelae of traumatic brain injury.
No obvious intracranial lesions or structural abnormalities identified on routine MRI examination.
Exclusion Criteria:
- Presence of contraindications to MRI examination, including MRI-incompatible implanted metallic or electronic devices, cochlear implants, cardiac pacemakers, intracranial metallic clips, or similar devices.
Severe claustrophobia preventing completion of the MRI examination. Pregnancy. Current or previous clinical diagnosis of severe neurological or psychiatric disorders.
History of severe head trauma, brain tumor, stroke, brain surgery, or other conditions that may substantially affect brain structure or function.
MRI data of insufficient quality for analysis due to marked discomfort, excessive head motion, or other causes during the examination.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Chinese Adults
Healthy Chinese adult volunteers will undergo standardized brain MRI examinations at multiple magnetic field strengths according to the study protocol.
|
Participants will undergo standardized brain MRI examinations at 0.55T, 1.5T, 3T, 5T, and 7T.
MRI acquisitions include structural, diffusion, functional, and quantitative imaging sequences according to the study protocol.
No therapeutic intervention will be administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Regional Gray Matter Volume Across MRI Field Strengths
Time Frame: From enrollment through completion of all scheduled multi-field-strength MRI examinations, up to 12 months
|
Regional gray matter volumes will be quantified from standardized structural MRI data and compared across 0.55T, 1.5T, 3T, 5T, and 7T MRI acquisitions.
|
From enrollment through completion of all scheduled multi-field-strength MRI examinations, up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
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
Other Study ID Numbers
- K202607-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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