Pilot Clinical Evaluation of a Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Tumor uptake of 68Ga-NY104
研究概览
简要总结
The goal of this pilot clinical trial is to see the potential application of a CAIX targeted PET. tracer in patients with clear cell renal cell carcinoma. The main question[s] it aims to answer are:
- The biodistribution of the PET tracer
- Whether RCC lesions can be identified by the PET tracer Participants will undergo 68Ga-NY104 PET/CT scan and images will be reviewed by nuclear medicine specialists.
详细描述
PET/CT imaging of three patients using 68Ga-NY104 for medical reasons will be performed. Patients received an intravenous injection of 68Ga-NY104. Images will be obtained at 0.5 h, 1 h, and 2 h after injection. A comparative 18F-FDG PET/CT scan will also be performed if necessary. The study will be carried out on a time-of-flight PET/CT scanner. SUVmax and SUVmean of normal organs and lesions, as well as tumor-to-background ratios, will be quantitatively assessed using a region-of-interest technique.
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
- •Confirmed or suspected metastatic ccRCC
- •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
- •Patients on VEGF TKI treatment < 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC. 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.
- •Pregnancy or breastfeeding.
- •Severe claustrophobia.
研究组 & 干预措施
PET scan
Patients will receive an intravenous injection of 68Ga-NY104
干预措施: 68Ga-NY104 (Drug)
结局指标
主要结局
Tumor uptake of 68Ga-NY104
时间窗: From study completion to 2 hour after completion
Uptake measured by SUVmax and SUVmean in suspected tumor lesions
Biodistribution of 68Ga-NY104 in normal organs
时间窗: From study completion to 2 hour after completion
Uptake measured by SUVmax and SUVmean in normal organs using a region-of-interest technique
次要结局
未报告次要终点