Brain Diseases on 7.0T Magnetic Resonance Imaging

Not Applicable

Recruiting

• Conditions: Brain Tumor; MRI; Cerebrovascular Disease

• Registration Number: NCT05287750
• Lead Sponsor: Chinese PLA General Hospital

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.

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-07
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

• Age<18 or >80
• Pregnancy and other contraindication to MRI scan
• Informed consent not obtained

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China