Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Biodistribution
研究概览
简要总结
The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.
详细描述
Enrolled patients will undergo whole-body PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.
Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years old and of either sex；
- •Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
- •Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
排除标准
- •Severe hepatic and renal insufficiency;
- •History of serious surgery in the last month;
- •Allergic to antibody or single-domain antibody radiopharmaceuticals.
研究组 & 干预措施
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [68Ga]Ga-DOTA-H2D3 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [18F]F-RESCA-RB14 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-T4 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [18F]F-RESCA-T4 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-G5 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [18F]F-RESCA-G5 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-WWH347 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [18F]F-RESCA-WWH347 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-RND20 (Drug)
ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
干预措施: [18F]F-RESCA-RND20 (Drug)
结局指标
主要结局
Biodistribution
时间窗: 1 day from injection of the tracers
Measurement of the overall biodistribution of above tracers in normal tissues and organs.
Standardized uptake value (SUV)
时间窗: 1 day from injection of the tracers
Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions.
Radiation dosimetry
时间窗: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.
Diagnostic value in patients with digestive system malignancy
时间窗: 30 days
Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics and, more importantly, the clinical value of these target-specific tracers in patients with malignancies of the digestive system.
The correlation between the expression of specific target and tracer uptake value
时间窗: 60 days
The Standardized uptake value (SUV) will be calculated, and the correlation between pathological results and tumor uptake of these tracers will be analyzed.
次要结局
- Predictive value of these tracers in the course of combined immunotherapies and targeted therapies(3-6 months)
- Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy(3-6 months)