First Affiliated Hospital of Fujian Medical University
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- SUVmax
研究概览
简要总结
Both fibroblast activation protein (FAP)-targeted imaging and somatostatin receptors (SSTR)-targeted imaging were the promising imaging modalities for the diagnosis of primary and metastatic nasopharyngeal carcinoma (NPC). This prospective study is going to investigate to compare the diagnostic efficacy of 68Ga-FAPI and 68Ga-DOTATATE in detecting primary and metastatic NPC lesions, thereby obtaining a more accurate examination method of NPC.
详细描述
Patients with newly diagnosed or previously treated NPC will be recruited in this study.
Each patient received an intravenous injection of 68Ga-DOTATATE (2-4mCi) on the first day and 68Ga-FAPI (2-4mCi) on the second day. Whole-body PET/CT scans were performed at 40-60 min after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and lesion uptake were compared.
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
- •Patients of either gender, aged ≥ 18 years.
- •Patients with newly diagnosed or previously treated NPC
- •A diagnostic magnetic resonance imaging (MRI) of the tumor region within the previous 1 weeks prior to dosing day is available.
- •signed written consent.
排除标准
- •pregnancy
- •breastfeeding
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT
NPC patients receive a single intravenous injection of 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT (2-4mCi) PET/CT,and undergo PET/CT scan at 40-60 min post-injection.
干预措施: 68Ga-DOTATATE and 68Ga-FAPI (Drug)
结局指标
主要结局
SUVmax
时间窗: through study completion, an average of 2 years
Determination of SUV for detected lesions and discernible organs of 68Ga-FAPI and 68Ga-DOTATATE scan.
Lesion numbers
时间窗: through study completion, an average of 2 years
Determination of lesion numbers of 68Ga-FAPI and 68Ga-DOTATATE scan.
次要结局
未报告次要终点
研究者
Weibing Miao, PhD
Director of Nuclear Medicine Department
First Affiliated Hospital of Fujian Medical University