Targeted Molecular Imaging of [68Ga]- Labelling Anti-EGFR Affibody Molecule in EGFR ECD in Lung Cancer Patients and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 PET/CT Imaging
研究概览
简要总结
The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.
详细描述
The goals of investigators are to evaluate the use of [68Ga]-labelling Anti-EGFR Affibody Molecule as a novel PET/CT radiotracer to monitor EGFR-ECD expression status and classify EGFR-ECD benefit NSCLC patients. The investigators want to evaluated the use of [68Ga]-labelling Anti-EGFR Affibody Molecule in lung cancer imaging in adult NSCLC patients with different EGFR-ECD expression status of primary and metastatic cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Advanced NSCLC
- •18 years or older
- •A life expectancy of at least 12 weeks
- •Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
- •Written informed consent
排除标准
- •Claustrophobia
- •Pregnancy
- •Metal implants in the thorax
结局指标
主要结局
tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 PET/CT Imaging
时间窗: at time of imaging
To quantify the accumulation, a volume of interest using a 3-D sphere, was placed over the primary lung tumor, lymph nodes and distant metastases avoiding necrosis, blood vessels and normal lung tissue as much as possible on a workstation (Advantage Workstation 4.6; GE Healthcare). The maximum standard uptake value (SUVmax) normalized to body weight (kBq/mL) was calculated within the region of interest.
次要结局
未报告次要终点
研究者
Xilin Sun
Chief
Harbin Medical University