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Brain Diseases on 7.0T Magnetic Resonance Imaging

Primary Purpose

Brain Tumor, MRI, Cerebrovascular Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnetic resonance imaging
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Brain tumor, Cerebrovascular disease, MRI, Ultra high field

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Outcomes

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
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
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
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
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

Full Information

First Posted
January 7, 2022
Last Updated
March 15, 2022
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05287750
Brief Title
Brain Diseases on 7.0T Magnetic Resonance Imaging
Official Title
Brain Diseases on 7.0T Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, MRI, Cerebrovascular Disease
Keywords
Brain tumor, Cerebrovascular disease, MRI, Ultra high field

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
Patients recruited will receive Magnetic resonance imaging.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
within a month after biopsy
Title
The visibility of white matter tracts on 7T MRI
Description
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.
Time Frame
within a month after biopsy
Secondary Outcome Measure Information:
Title
The correlation between the ROI's signal intension on 7T MRI scan and the KPS in 1 month after operation
Description
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
Time Frame
within a month after biopsy
Title
The visibility of white matter tracts on 7T MRI and 3T MRI
Description
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
Time Frame
Six months after the biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Cheng, M.S.
Phone
+86 19921784434
Email
dr_chengkun@163.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Cheng, M.S.
Phone
+8619921784434
Email
dr_chengkun@163.com

12. IPD Sharing Statement

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Brain Diseases on 7.0T Magnetic Resonance Imaging

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