68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Quantitative measurement of standardized uptake values (SUVs) of lesions.
研究概览
简要总结
Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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.
- •The definite diagnosis of lung cancer was established by pre-operational bronchoscopic or puncture biopsy or the definite diagnosis of lung tuberculomas was established on the basis of positive sputum culture examinations and confirmed by follow-up.
- •Without any treatment or resection surgury.
- •All the biopsies are done at least 10 days before PET/CT scans.
- •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
In patients in suspicion of lung cancer or lung tuberculosis; in patients with differential diagnosis difficulties; without treatment or surgery. They underwent a standard routine 18F-FDG PET/CT first, and were injected 10~20MBq 68Ga-Alfatide II in the next day, followed by whole body PET/CT acquisitions.
干预措施: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG (Radiation)
结局指标
主要结局
Quantitative measurement of standardized uptake values (SUVs) of lesions.
时间窗: 1 year
The quantitative analysis will be performed by the same person for all cases, and the standardized uptake value (SUV) of each tumor will be measured using a volume of interest (VOI) method.
次要结局
- Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning.(1 year)