CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Standardized uptake value（SUV）
研究概览
简要总结
The objective of the study is to construct a noninvasive approach 68Ga-NC-BCH PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •1. Aged >18 years old; ECOG 0 or 1;
- •2. Patients with solid tumors;
- •3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
- •4. life expectancy >=12 weeks.
排除标准
- •1. Significant hepatic or renal dysfunction;
- •2. Is pregnant or ready to pregnant;
- •3. Cannot keep their states for half an hour;
- •4. Refusal to join the clinical study;
- •5. Suffering from claustrophobia or other mental diseases;
- •6. Any other situation that researchers think it is not suitable to participate in the experiment.
研究组 & 干预措施
68Ga-ACN376
Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-ACN376 PET/CT scan.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Standardized uptake value（SUV）
时间窗: 2 years
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-ACN376） in solid tumor lesions by measuring SUV on PET/CT.
Standardized Uptake Value (SUV) of 68Ga-NC-BCH
时间窗: 2 years
SUV is a semiquantitative index commonly used in PET to quantify tissue metabolic activity, calculated as the ratio of the radioactivity concentration in the tissue of interest to the injected dose normalized by body weight. Bio-distribution of the tracer will be assessed by measuring the Standardized Uptake Value (SUV) in normal organs (e.g., liver, spleen, kidney) via PET/CT imaging at specified time points post-injection.
次要结局
- Diagnostic performance(4 years)
研究者
Hua Zhu
Associate Professor
Peking University Cancer Hospital & Institute