MR 7700 Multinuclear Application Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MR Scanning with Phosphorus nucleus + Sodium nucleus.
- Who it may be relevant to
- Registry conditions: MR Multinuclear, Image Quality, Device Convenience, Device Stability. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MR 7700 Multinuclear Application Clinical Study
Overview
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
- Device MR Scanning with Phosphorus nucleus + Sodium nucleus
Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning
Primary outcome measures
- The excellent and good rate of Spectral image quality of 31P-MRS [Time frame: 14 days (anticipated) after finishing 31P-MRS scanning]
- The excellent and good rate of image quality of 23Na-MRI [Time frame: 14 days (anticipated) after finishing 23Na-MRI scanning]
Secondary outcome measures (4)
- The Device convenience of the entire system [Time frame: 14 days (anticipated) after finishing scanning]
- Device stability [Time frame: 14 days (anticipated) after finishing scanning]
- System security [Time frame: 14 days (anticipated) after finishing scanning]
- Adverse event [Time frame: From the time the subjects signed the ICF to completion of study visit(1 day).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07368036 · 300957