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
- 100
- 主要终点
- Ratio of metabolites （PME/PDE）
研究概览
简要总结
The purpose of this clinical study is to perform phosphorus nucleus (31P) and sodium nucleus (23Na) imaging of the liver in patients with primary hepatocellular carcinoma (HCC) and healthy volunteers using the MR 7700 Magnetic Resonance Equipment, in order to explore the manifestations of multinuclear imaging in HCC patients and healthy volunteers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. HCC patient group
- •Age ≥ 18 years;
- •With clear consciousness, ability to cooperate, and autonomous behavior;
- •Voluntary agreement to participate in this clinical trial and signing of the subject's informed consent form;
- •Patients diagnosed with primary hepatocellular carcinoma by imaging or clinical diagnosis, and who have not received tumor treatment.
- •2. Healthy control group
- •Age ≥ 18 years;
- •With clear consciousness, ability to cooperate, and autonomous behavior;
- •Voluntary agreement to participate in this clinical trial and signing of the subject's informed consent form;
- •No previous history of liver disease.
排除标准
- •HCC patient group and healthy control group
- •Patients with claustrophobia.
- •Subject's body temperature > 39.5°C on the day of scanning.
- •Females who plan to be pregnant within 6 months, and pregnant and lactating females.
- •Patients with other implants, prostheses, foreign bodies, patches, etc. that are not suitable for MRI examination; patients with electronic implants, such as pacemakers, stimulators, insulin pumps, cochlear implants, etc.
- •Critically ill subjects with various resuscitation devices or those with any emergency medical condition requiring first aid.
- •Subjects with poor compliance are considered to be excluded by the investigators.
- •Subjects who are not considered suitable for this trial by the investigators.
研究组 & 干预措施
HCC patients
HCC patients
干预措施: MR Scanning with Phosphorus nucleus + Sodium nucleus (Device)
Healthy volunteers
Healthy volunteers
干预措施: MR Scanning with Phosphorus nucleus + Sodium nucleus (Device)
结局指标
主要结局
Ratio of metabolites （PME/PDE）
时间窗: 14 days (anticipated)] after finishing 31P-MRS scanning
By comparing the ratios of metabolites (PME/PDE) in the liver, the effectiveness of 31P magnetic resonance spectroscopy (31P-MRS) was evaluated. Theoretically,the PME/PDE ratio in patients with HCC was higher than that in healthy volunteers.
Image quality of 23Na-MRI
时间窗: 14 days (anticipated)] after finishing 23Na-MRI scanning
Image quality will be assessed by Likert score (1-5)
Adverse Event
时间窗: From the time the subjects signed the ICF to completion of study visit(1 day).
Monitor adverse events and serious adverse events during the study,summarize and analyze the frequency and percentage of all adverse events (including severe adverse events)
次要结局
未报告次要终点