68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Standardized uptake value (SUV)
研究概览
简要总结
To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.
详细描述
Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
排除标准
- •(i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
Experimental: 68Ga-DOTA/NOTA-FAPI-04
Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.
干预措施: PET/CT scan (Diagnostic Test)
Experimental: 68Ga-DOTA/NOTA-FAPI-04
Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.
干预措施: 68Ga-DOTA/NOTA-FAPI-04 (Drug)
结局指标
主要结局
Standardized uptake value (SUV)
时间窗: 30 days
Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.
次要结局
- Diagnostic efficacy(30 days)
研究者
Weibing Miao, PhD
Director, Department of Nuclear Medicine
First Affiliated Hospital of Fujian Medical University