68Ga-NY104 PET/CT and 18F-FDG PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma: a Prospective, Single Center, Single Arm, Comparative Imaging Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Positivity of lesions detected by 18F-FDG PET
研究概览
简要总结
This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and compare it with 18F-FDG PET/CT.
详细描述
This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. Each patient will receive one dose of 68Ga-NY104 and one dose of 18F-FDG by intravenous route. Dedicated whole-body PET/CT imaging will be performed. PET/CT studies will be interpreted by two readers, both of whom will provide independent, blinded interpretations. Imaging interpretations and a composite reference standard will be used to estimate the sensitivity of each modality. The tumor uptake will also be compared for matched lesions.
39 patients will be recruited in Peking Union Medical College Hospital.
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
- •Histopathological diagnosis of clear cell renal cell carcinoma
- •Metastatic disease confirmed by histopathology or typical appearance of multifocal metastatic disease
- •Expected survival of at least 6 months
- •Written informed consent provided for participation in the trial
- •In the opinion of investigator, willing and able to comply with required study procedures.
排除标准
- •On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY
- •If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
- •Patients on HIF antagonist treatment < 3 months before 68Ga-NY104 PET/CT. CA9, which encodes carbonic anhydrase IX (CAIX), is one of the genes most strongly upregulated by HIF-
- •HIF antagonist, such as Belzutifan, might affect the expression of CAIX and thus the binding of 68Ga-NY104 to tumor. Withdraw of at least 3 months is required for HIF antagonist.
- •Pregnancy or breastfeeding.
- •Severe claustrophobia.
结局指标
主要结局
Positivity of lesions detected by 18F-FDG PET
时间窗: From study completion to 1 month after completion
Any focal accumulation that cannot be explained by physiologic uptake of 18F-FDG will be interpreted as focal lesion.
Positivity of lesions detected by 68Ga-NY104 PET
时间窗: From study completion to 1 month after completion
Any focal accumulation that cannot be explained by physiologic uptake of the 68Ga-NY104 will be interpreted as focal lesion.
次要结局
- SUVmax of lesions detected by 68Ga-NY104 PET(From study completion to 1 month after completion)
- SUVmax of lesions detected by 18F-FDG PET(From study completion to 1 month after completion)