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Clinical Trials/NCT05287750
NCT05287750
Recruiting
Not Applicable

Brain Diseases on 7.0T Magnetic Resonance Imaging

Chinese PLA General Hospital1 site in 1 country200 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Tumor
Sponsor
Chinese PLA General Hospital
Enrollment
200
Locations
1
Primary Endpoint
The visibility of white matter tracts on 7T MRI
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
September 1, 2026
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xin Lou

Director and Clinical Professor

Chinese PLA General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

The visibility of white matter tracts on 7T MRI

Time Frame: 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

Time Frame: 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 Outcomes

  • 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 visibility of white matter tracts on 7T MRI and 3T MRI(Six months after the biopsy)

Study Sites (1)

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