NCT06165874招募中不适用
[68Ga]Ga-NOTA-RW102 PET Imaging in the Diagnosis of PD-L1-expressing Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Calculation and comparison of [68Ga]Ga-NOTA-RW102 radioactivity concentrations in focal and non-focal tissues
研究概览
简要总结
The aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RW102, as well as its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent was evaluated in patients with non-small cell lung cancer
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PD-L1-positive non-small cell lung cancer
- •Age between 18 and 65 years old, gender is not limited.
- •Patients with CT findings that can be occupied on the lung with a diameter greater than 1cm or more who have not undergone surgery.
- •Lung cancer patients with a clinical diagnosis of positive PD-L1 expression;
- •Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
- •Willingness and ability to cooperate with all programs of this study.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •Severe hepatic and renal insufficiency;
- •Targeted therapy prior to radiotherapy or PET/CT scan. PD-L1 expression in existing lesions was assessed by immunohistochemistry using antibody clone 22C
- •Renal function: serum creatinine less than or equal to the upper limit of the normal range;
- •Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
- •History of serious surgery in the last month.
- •Those who have participated in other clinical trials during the same period.
结局指标
主要结局
Calculation and comparison of [68Ga]Ga-NOTA-RW102 radioactivity concentrations in focal and non-focal tissues
时间窗: 90mins from time of injection
Assessment of the efficacy of \[68Ga\]Ga-NOTA-RW102 in the diagnosis and differential diagnosis of non-small cell lung cancer
次要结局
未报告次要终点
研究者
研究点 (1)
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