Study of Melanoma-Resistant PET Monitoring Based on Key Rate-limiting Enzymes for Fatty Acid Metabolism in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- The maximum standardized uptake value (SUVmax)
研究概览
简要总结
This is a small-sample safety study involving 15 healthy volunteers who were divided into groups and underwent 68Ga-ACC-DE, 68Ga-FASN-DE, and 68Ga-ACLY-DE PET/CT imaging for safety, biodistribution, and radiation dosimetry assessments, laying the foundation for subsequent studies on the efficacy of resistance monitoring in melanoma targeted therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 to 65 years old (including the boundary values); Gender: Male or female; Weight: Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI = weight (kg) / height² (m²)) within the range of 18.0 to 28.0 kg/m² (including boundary values); Participants must fully understand and voluntarily participate in this experiment and sign an informed consent form.
排除标准
- •Individuals who cannot tolerate intravenous administration (e.g., those with a history of fainting from needles or blood); Individuals with alcohol allergies; Pregnant or breastfeeding women; Individuals with severe diseases of the heart, kidneys, lungs, blood vessels, nervous system, or mental health, immune deficiency diseases, or hepatitis/cirrhosis; Individuals whom the investigator deems unsuitable for or unable to complete PET or other imaging examinations for special reasons; Other circumstances deemed by the investigator to be unsuitable for participation in this study.
结局指标
主要结局
The maximum standardized uptake value (SUVmax)
时间窗: One hour after injection of the tracer
The maximum standardized uptake value (SUVmax) of 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE in the target population.
The maximum standardized uptake value (SUVmax)
时间窗: One hour after injection of the tracer
The maximum standardized uptake value (SUVmax) of 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE in the target population.
次要结局
未报告次要终点