68Ga-NOTA Evans Blue PET/CT in Patients With Lymphatic System Related Diseases
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 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-NOTA Evans Blue (68Ga-NEB) positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and efficacy assessment in lymphatic system related diseases.
详细描述
Subjects with lymphatic system related diseases underwent 68Ga-NEB PET/CT either for a primary diagnosis or for efficacy assessment. Anomalies were detected by visual analysis and quantitative analysis of maximum standard uptake value (SUVmax). To compare the diagnostic sensitivity of 68Ga-NEB PET/CT lymphatic imaging with other lymphatic imaging such as 99mTc-dextran for lymphatic system related diseases.
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
- •adult population (aged between18 years and 80 years)
- •patients with suspected or new diagnosed or previously treated lymphatic system related diseases
- •patients who had scheduled 68Ga-NEB PET/CT scan
- •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
- •patients with pregnancy
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
68Ga-NOTA Evans Blue PET/CT in Patients with Lymphatic System Related Diseases
A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA Evans Blue will be injected subcutaneously. PET/CT imaging will be performed at 5-30 min post- injection. Visual and quantitative method will be used to assess the PET/CT images.
干预措施: 68Ga-NOTA Evans Blue (Drug)
结局指标
主要结局
Standardized uptake value (SUV)
时间窗: through study completion, an average of 3 years
Standardized uptake value (SUV) of 68Ga-NEB for each target lesion of subject.
Visual analysis of lymphatic patency
时间窗: through study completion, an average of 3 years
The bilateral lymphatic description on 68Ga-NEB PET/CT and lymphatic SPECT imaging were compared. The patency of lymphatic vessels (including lymphatic disruption, dermal distribution, and so on, results are indicated by 0 and 1) are shown in two imagings were recorded respectively.
次要结局
- Diagnostic efficacy(through study completion, an average of 3 years)
研究者
Weibing Miao, PhD
Director, Department of Nuclear Medicine
First Affiliated Hospital of Fujian Medical University