Device Convenience, Device Stability, Image Quality, MR Multinuclear, System Safety
Conditions
Keywords
multinuclear, MR
Brief summary
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.
Interventions
Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* • 18 ≤ Age ≤ 75 years old; * Clear mind, able to cooperate, and capable of autonomous behavior; * Voluntarily agree to participate in this clinical trial and sign the informed consent form for the subjects
Exclusion criteria
* • Individuals with claustrophobia. * On the day of scanning, the subject's body temperature was above 39.5 ℃. * Plan to become pregnant, pregnant, and breastfeeding women within 6 months. * Other implants, prostheses, foreign bodies, patches, etc. that are not suitable for magnetic resonance imaging examination; There are electronic implants such as pacemakers, stimulators, insulin pumps, cochlear implants, etc. * Critical patients equipped with various rescue devices, as well as subjects with any emergency medical conditions requiring first aid. * Subjects with poor compliance, which the researchers believe should be excluded. * Other situations that the investigators believe are not suitable for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The excellent and good rate of Spectral image quality of 31P-MRS | 14 days (anticipated) after finishing 31P-MRS scanning | 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%. |
| The excellent and good rate of image quality of 23Na-MRI | 14 days (anticipated) after finishing 23Na-MRI scanning | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Device convenience of the entire system | 14 days (anticipated) after finishing scanning | 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. |
| Device stability | 14 days (anticipated) after finishing scanning | 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. |
| System security | 14 days (anticipated) after finishing scanning | 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. |
| Adverse event | From the time the subjects signed the ICF to completion of study visit(1 day). | 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. |
Contacts
CONTACTBing Zhang
CONTACTAndi Gao
Outcome results
None listed