MR 7700 Multinuclear Application Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- The excellent and good rate of Spectral image quality of 31P-MRS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 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
排除标准
- •• 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.
研究组 & 干预措施
Healthy volunteers
干预措施: MR Scanning with Phosphorus nucleus + Sodium nucleus (Device)
Patient
干预措施: MR Scanning with Phosphorus nucleus + Sodium nucleus (Device)
结局指标
主要结局
The excellent and good rate of Spectral image quality of 31P-MRS
时间窗: 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
时间窗: 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%.
次要结局
- The Device convenience of the entire system(14 days (anticipated) after finishing scanning)
- Device stability(14 days (anticipated) after finishing scanning)
- System security(14 days (anticipated) after finishing scanning)
- Adverse event(From the time the subjects signed the ICF to completion of study visit(1 day).)