The purpose of this clinical trial is to use the medical magnetic resonance imaging system MR 7700 to perform phosphorus (31P) and sodium (23Na) scanning imaging on the human body, evaluate the image quality of phosphorus (31P) and sodium (23Na) scanning, as well as the machine convenience, machine stability, and system safety of the entire system.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning
The excellent and good rate of Spectral image quality of 31P-MRS
Spectral image quality of phosphorus nucleus (31P) in each site (muscle, liver, heart)，will be assessed by Likert score (1-5) . The final evaluation of image quality at 3 points or above is considered excellent and good.The rate of excellent and good should be over 75%.
Time frame: 14 days (anticipated) after finishing 31P-MRS scanning
The excellent and good rate of image quality of 23Na-MRI
Image quality of sodium nuclei (23Na) in each site (liver, cartilage), will be assessed by Likert score (1-5) . The final evaluation of image quality at 3 points or above is considered excellent and good.The rate of excellent and good should be over 75%.
Time frame: 14 days (anticipated) after finishing 23Na-MRI scanning
The Device convenience of the entire system
A three-scale assessment will be used for evaluate the device convenience of the entire system from the aspects of subject positioning, scanning interface, scanning sequence, image processing, microphone communication, and image storage/transmission and management. A three-scale criteria- Satisfied, General, Dissatisfied Assessment criteria: The parameters should all reach "General or Satisfied", indicating that the case meet the device convenience.
Time frame: 14 days (anticipated) after finishing scanning
Device stability
Evaluate the stability of the device from the aspects of system startup, system shutdown, abnormal interruption during scanning, image display after scanning, and missing image reconstruction. A three-scale criteria- Satisfied, General, Dissatisfied. Assessment criteria: The parameters should all reach "General or Satisfied", indicating that the case meet the device stability.
Time frame: 14 days (anticipated) after finishing scanning
System security
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The technician observes whether there are any system safety issues during the scanning of each image instance After the scan, a "yes" or "no" judgment is made based on the occurrence of each assessment item. If all assessment items are rated as "none", it indicates that the system is safe.
Time frame: 14 days (anticipated) after finishing scanning
Adverse event
Analyze the adverse events during the clinical trial process, summarize and analyze the frequency and percentage of all adverse events (including serious adverse events) in a list, and classify them based on their correlation with the device.
Time frame: From the time the subjects signed the ICF to completion of study visit(1 day).