68Ga-NY104 PET/CT Imaging in Patients With Confirmed or Suspicious Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Binary reading of focal lesions identified on 68Ga-NY104 PET/CT
研究概览
简要总结
This is a prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma.
详细描述
Two types of patients will be recruited in this study. Type 1, patients with renal masses scheduled for surgery, type 2, patients with confirmed or suspicious recurrent/metastatic ccRCC. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68G-NY104 PET/CT.
46 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.
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
- 否
入选标准
- •Written informed consent provided for participation in the trial
- •at least one of the following indications should be applied
- •Scheduled for surgical resection of renal mass
- •confirmed recurrent/metastatic clear cell renal cell carcinoma
- •suspicion for recurrent/metastatic clear cell renal cell carcinoma
排除标准
- •On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT.
- •Pregnancy or lactation
- •Severe claustrophobia.
结局指标
主要结局
Binary reading of focal lesions identified on 68Ga-NY104 PET/CT
时间窗: From study completion to 1 month after completion
Define lesion as PET positive or PET negative lesion.
次要结局
- SUVmax of focal lesions identified on 68Ga-NY104 PET/CT(From study completion to 1 month after completion)