Brain Diseases on 7.0T Magnetic Resonance Imaging

Brain Tumor Clinical Trial

Official title:

Brain Diseases on 7.0T Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287750
• Other study ID #: Brain Diseases-ChinaPLAGH
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Neoplasms
• Brain Tumor
• Cerebrovascular Disease
• Cerebrovascular Disorders
• MRI

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