Clinical Study of 68GA-labeled Claudin 18.2 Developer Combined with PET/CT for Imaging of Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Biological distribution characteristics
研究概览
简要总结
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range of 18 to 75 years old (including boundary values);
- •Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
- •Diagnosed G/GEJ adenocarcinoma and pancreatic cancer;
- •Gastroscopy/CT/MRI/PET-CT examination results within the past month (if any);
- •Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).
排除标准
- •Merge patients with other clearly diagnosed malignant tumors:
- •Uncontrolled severe infections or individuals with other serious illnesses;
- •Those with an expected survival period of less than or equal to three months;
- •Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;
- •investigators determine that patients who are not suitable to participate in this study;
研究组 & 干预措施
dose escalation
subgroups mass does escalation
干预措施: [68Ga]Ga-NODAGA-SNA014 (Drug)
结局指标
主要结局
Biological distribution characteristics
时间窗: 1week
Evaluate the biological distribution characteristics of important organs in the subjects. * Draw the Volume of Interest (VOI) of the subject's vital organs and calculate the Percentage of Injected Activity (IA) of the vital organs * Using PMOD software, manually draw regions of interest (VOI) on PET/CT images of the liver, spleen, normal stomach, heart, bone marrow, kidneys, and other areas to obtain the cumulative radioactive activity of these regions. Divide the cumulative radioactive activity by the injection dose to obtain the percentage of injection activity (% IA).
Safety tolerance characteristics
时间窗: hrough study completion, an average of 1 year
AE/SAE/SUSAR
次要结局
- Metabolic Dynamics Evaluation and Radiation Dose(1 day)