Evaluation of Diagnostic Value of 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors
研究概览
简要总结
The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1.
Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
详细描述
Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent；
- •Patients with confirmed or suspected clear cell renal cell carcinoma;
- •Expected survival ≥6 months.
排除标准
- •Renal mass is known to be a metastasis of another primary tumor;
- •Have other malignancies that require treatment;
- •Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks;
- •Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²;
- •Pregnant and lactating women or female patients plan to become pregnant within 6 months;
- •Uncontrolled psychiatric disorders;
- •Vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).
研究组 & 干预措施
68Ga-C1
Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.
干预措施: 68Ga-C1 (Drug)
结局指标
主要结局
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors
时间窗: 1 year
Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma
时间窗: 1 year
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT
次要结局
- Quantitative evaluation of 68Ga-C1(1 year)
- The dosimetry of 68Ga-C1(1 year)
- Correlation with pathological expression(1 year)
研究者
GONG Kan
Surgeon
Peking University First Hospital