Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Standardized uptake value (SUV)
研究概览
简要总结
The aim of this study is to establish and optimize the Trop2/HER2-targeted 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 breast cancer will be evaluated.
详细描述
Enrolled patients will undergo whole-body[18F]F-RESCA-RT4(Trop2-targeted imaging probes ) or [18F]F-RESCA-RB14(HER2-targeted imaging probes) 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years old and of female gender；
- •Histologically confirmed diagnosis of breast cancer or suspected breast cancer 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
Trop2/HER2-targeted immunoPET imaging
Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.
干预措施: [18F]F-RESCA-RB14 (Drug)
Trop2/HER2-targeted immunoPET imaging
Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.
干预措施: [18F]F-RESCA-RT4 (Drug)
结局指标
主要结局
Standardized uptake value (SUV)
时间窗: 1 day from injection of the tracer
Standardized uptake value (SUV) of \[18F\]F-RESCA-RT4/ \[18F\]F-RESCA-RB14 in the included subjects' primary and/or metastatic lesions.
Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer
时间窗: 30 days
We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of \[18F\]F-RESCA-RT4/\[18F\]F-RESCA-RB14 PET/CT in patients with breast cancer. We will also compare the diagnostic value of above probes with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., MRI). All the above goals will be achieved by analyzing the static/dynamic\[18F\]F-RESCA-RT4/\[18F\]F-RESCA-RB14 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of \[18F\]F-RESCA-RT4/\[18F\]F-RESCA-RB14 PET/CT for patients with breast cancer.
Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14
时间窗: 1 day from injection of the tracer
Measurement of the overall biodistribution of above probes in normal tissues and organs.
Radiation dosimetry of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14
时间窗: 1 day from injection of the tracer
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.
The correlation between Trop2 expression and [18F]F-RESCA-RT4 uptake value
时间窗: 60 days
The Standardized uptake value (SUV) of \[18F\]F-RESCA-RT4 will be calculated, and the correlation between pathological results and tumor uptake of\[18F\]F-RESCA-T4 will be analyzed.
The correlation between HER2 expression and [18F]F-RESCA-RB14 uptake value
时间窗: 60 days
Standardized uptake value (SUV) of \[18F\]F-RESCA-RB14 will be calculated, and the correlation between pathological results and tumor uptake of \[18F\]F-RESCA-RB14 will be analyzed.
次要结局
- Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer(3-6 months)
- The predictive value of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the course of targeted therapies(3-6 months)