A Study of the Clinical Application of [18F]RCCB6 PET/ CT Imaging in the Diagnosis of Kidney Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Biodistribution of [18F]RCCB6
研究概览
简要总结
The aim of this study is to establish and optimize the [18F]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.
详细描述
Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging will be included. Especially patients with suspected metastases or routine follow-up or surveillance or suitable for systemic treatments (e.g., combined immunotherapy and targeted therapies) will undergo [18F]RCCB6 immunoPET/CT scans. Enrolled patients will undergo whole-body [18F]RCCB6 immunoPET/CT scans at 1 hour after tracer injection(0.05-0.1 mCi/kg). Uptake of [18F]RCCB6 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. Furthermore, we will compare the diagnostic rates of [18F]RCCB6 immunoPET/CT with those of conventional imaging examinations, such as CT, MRI, and 18F-FDG PET/CT, etc.The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. Further explore the value of [18F]RCCB6 in treatment decision-making（staging, surveillance, and restaging） for kidney cancer.We will conduct an interim assessment when more than half of the patients have been enrolled.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 year-old and of either sex；
- •Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney 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
CD70-targeted immunoPET imaging
Enrolled patients will undergo a CD70-targeted immunoPET/CT scanning.
干预措施: [18F]RCCB6 (Drug)
结局指标
主要结局
Biodistribution of [18F]RCCB6
时间窗: 1 day from injection of the tracer
Measurement of the overall biodistribution of \[18F\]RCCB6 in normal tissues and organs.
The correlation between CD70 expression and [18F]RCCB6 uptake value
时间窗: 60 days
The Standardized uptake value (SUV) of \[18F\]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of \[18F\]RCCB6 will be analyzed.
To explore the diagnostic performance of [18F]RCCB6 PET with that of conventional imaging and [18F]FDG PET
时间窗: 6 months
Using pathological or follow-up imaging data as the gold standard, explore the diagnostic performance of \[18F\]RCCB6 PET compared to conventional imaging and \[18F\]FDG PET.
Standardized uptake value (SUV)
时间窗: 1 day from injection of the tracer
Standardized uptake value (SUV) of \[18F\]RCCB6 in the included subjects' primary and/or metastatic lesions.
Diagnostic value of [18F]RCCB6 PET in patients with ccRCC
时间窗: 30 days
We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of \[18F\]RCCB6 PET/CT in patients with ccRCC. We will also compare the diagnostic value of \[18F\]RCCB6 with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., CT and MRI). All the above goals will be achieved by analyzing the static/dynamic \[18F\]RCCB6 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of \[18F\]RCCB6 PET/CT for patients with ccRCC.
次要结局
- [18F]RCCB6 PET/CT in changing clinical decision-making for ccRCC patients(3-6 months)