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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05287750
Other study ID # Brain Diseases-ChinaPLAGH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date September 1, 2026

Study information

Verified date March 2022
Source Chinese PLA General Hospital
Contact Kun Cheng, M.S.
Phone +86 19921784434
Email dr_chengkun@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Intervention

Diagnostic Test:
Magnetic resonance imaging
Patients recruited will receive Magnetic resonance imaging.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 within a month after biopsy
Primary The visibility of white matter tracts on 7T MRI 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. within a month after biopsy
Secondary The correlation between the ROI's signal intension on 7T MRI scan and the KPS in 1 month after operation 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 within a month after biopsy
Secondary The visibility of white matter tracts on 7T MRI and 3T MRI 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 Six months after the biopsy
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