Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 68Ga-NEB in Healthy Volunteers and Patients With Hepatic Space-occupying Lesions and Suspicious Lymph Nodes Metastasis
试验速览
- 阶段
- 1 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging
研究概览
简要总结
This is an open-label whole-body PET/CT study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in healthy volunteers and patients with suspected infection. Changes of routine blood and urine tests and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
详细描述
The labeling of albumin has advantages as drawing blood is unnecessary and the operator labeling is not exposed to potentially infectious material. Evans blue (EB) dye has high affinity for serum albumin, The final obtained products NEB (a NOTA conjugate of a truncated form of Evans blue for in vivo albumin labeling) was proceeded strict quality controls.
No fasting, hydration or other specific preparation was requested on the day of imaging.
Patients for blood pool imaging underwent whole-body PET/CT acquisitions 30-45 min after intravenous injection of 111-148 MBq (3-4 mCi) 68Ga-NEB with each bed position lasted for 2 min and a standard routine 18F-FDG PET/CT within one week.
Patients for lymph node imaging including the breast nodules patients underwent a standard routine 18F-FDG PET/CT first, and were locally injected 10~20MBq 68Ga-NEB, followed by dynamic chest regional PET acquisitions.
A Siemens MMWP workstation was used for post-processing. Visual analysis was used to determine the general biodistribution and the temporal and intersubject stability. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 liver focal lesion(s). In suspicion of arteriovenous malformations. Newly diagnosed breast cancer and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available. Evaluation of cardiac function.
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 blood pool imaging:
The patients were intravenously injected with 68Ga-NEB and underwent PET/CT scan 30~45min after the injection.
Patients for lymph node imaging:
The patients were locally injected 10~20MBq 68Ga-NEB and followed by dynamic regional PET acquisitions.
干预措施: 68Ga-NEB (Drug)
结局指标
主要结局
Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging
时间窗: 1 years
次要结局
- Adverse events collection(2 week)
- Routine blood test(24 hours)
- Serum albumin(24 hours)
- Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET(2 years)
- Routine urine test(24 hours)