Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc.
试验速览
- 阶段
- 1 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Standardized uptake value of 68Ga NEB in lymphatic lesion
研究概览
简要总结
This is an open-label whole-body PET/CT study for investigating the value of 68Ga NEB PET imaging in the diagnosis and evaluation of lymphatic disorders including lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.
详细描述
No fasting, hydration or other specific preparation was requested on the day of imaging.
Patients for lymphatic drainage disorders imaging underwent whole-body PET/CT acquisitions 20-40 min after subcutaneously injected into first and second interdigital spaces of both feet or hands of 74-111 MBq (2-3 mCi) 68Ga-NEB with each bed position lasted for 2 min.
A MIM workstation was used for post-processing. The visual method was used to evaluate the lymphatic system, including the morphology and the distribution of the lymphatic system. Semiquantitative methods were applied for image analysis.
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
- •Must be able to provide a written informed consent; Males and females, ≥18 years old； Diagnostic CT or MRI suggesting a diagnosis of lymphatic system lesion(s). In suspicion of lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.
排除标准
- •Females planning to bear a child recently or with childbearing potential; Known severe allergy or hypersensitivity to IV radiographic contrast； Inability to lie still for the entire imaging time because of cough, pain, etc. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- •Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
研究组 & 干预措施
68Ga-NEB injection and PET/CT scan
Patients for lymphatic disorders imaging: The patients were subcutaneously injected with 68Ga-NEB and underwent PET/CT scan 20~40min after the injection.
干预措施: 68Ga-NEB (Drug)
结局指标
主要结局
Standardized uptake value of 68Ga NEB in lymphatic lesion
时间窗: 1 years
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in lymphatic lesion will be measured.
次要结局
- Adverse events collection(1 week)