MR 7700 Multinuclear Application Clinical Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPhilips Clinical & Medical Affairs Global
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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
Disqualifiers
• 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.
Trial design
Design model
Parallel
Treatments tested in this trial
MR Scanning with Phosphorus nucleus + Sodium nucleus
DeviceUsing the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Healthy volunteersExperimental treatment 1 intervention
Group B: PatientExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 scanning2
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 scanningSecondary outcomes
1
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 scanning2
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 scanning3
System security
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 scanning4
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).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: