Brain Diseases on 7.0T Magnetic Resonance Imaging

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05287750

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting brain diseases. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor MRI Cerebrovascular Disease	Diagnostic Test: Magnetic resonance imaging	N/A

Detailed Description

7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of brain diseases on 7T MRI.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Brain Diseases on 7.0T Magnetic Resonance Imaging

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Outcome Measures

Primary Outcome Measures

the correspondence between brain tumor cells found in the biopsies and region of interest(ROI) signal intension on the 7T MRI scan and 3T MRI scan [within a month after biopsy]
Pathological assessment of biopsy material compared with the lesion's contrast-enhancement signal intension to normal brain white mater on 7T MRI and 3T MRI
The visibility of white matter tracts on 7T MRI [within a month after biopsy]
Visualization of white matter tracts will be done with the use of diffusion tensor imaging (DTI) on 7T MRI and measuring the mean diffusivity (MD) value on Post-processing workstation ,and analysis the correlation between these values and pathological.

Secondary Outcome Measures

The correlation between the ROI's signal intension on 7T MRI scan and the KPS in 1 month after operation [within a month after biopsy]
The correlation analysis between the T1 contrast-enchanced signal intension, Regional cerebral blood flow on 7T MRI (clinical sequence and perfusion) scan and the KPS in 1 month after operation
The visibility of white matter tracts on 7T MRI and 3T MRI [Six months after the biopsy]
Visualization of white matter tracts will be done with the use of diffusion tensor imaging (DTI) on 7T MRI and 3T MRI. and analysis the difference of the mean diffusivity (MD) value between 7.0T MRI and 3.0T MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age≥18 and ≤80
Having brain diseases (eg: brain tumor, cerebrovascular diseases)
Having no contraindications against MRI or intravenous contrast agent administration
Clinically stable