NCT06856109进行中（未招募）不适用
68Ga-Pentikra PET/CT Imaging Study in Healthy Subjects
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年2月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum Standardized uptake value
研究概览
简要总结
This is a prospective, interventional clinical pilot study that recruited 10 normal volunteers who underwent 68Ga-Pentikra PET/CT imaging to evaluate the safety, biodistribution and radiation dosimetry of 68Ga-Pentikra in normal volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 ~ 60 years old (including boundary values); 2) Gender: male or female; 3) Body weight: males weighing ≥50kg, females weighing ≥45kg, and body mass index [BMI = weight (kg)/height 2 (m2)] within the range of 19.0 ~ 26.0kg/m2 (including boundary values); (4) Subjects can fully understand and voluntarily participate in this experiment, and sign the informed consent form.
排除标准
- •Minors, pregnant women, lactating women, and those with severe hepatic or renal insufficiency (alanine aminotransferase exceeding the upper limit of normal values by 8-10 times and serum creatinine of 186-442 umol/L).
- •Previous history of tumour and surgery; 3) Other conditions judged by the investigator to be unsuitable as study subjects .
研究组 & 干预措施
healthy volunteers
Experimental
Ten normal volunteers were recruited to perform 68Ga-Pentikra PET/CT imaging to assess the safety, biodistribution and radiation dosimetry of 68Ga-Pentikra.
干预措施: 68Ga-Pentikra PET/CT Scan (Diagnostic Test)
结局指标
主要结局
Maximum Standardized uptake value
时间窗: 1 day from injection of the tracer
68Maximum standardised uptake values of Ga-Pentikra in regions of interest (ROIs) of the heart, lungs, liver, kidneys, spleen and brain in healthy subjects
次要结局
未报告次要终点
研究者
研究点 (1)
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