NCT06641674尚未招募不适用
Development and Clinical Translation of EGFR Mutation Targeting PET Probe
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Standard Uptake Value Value
研究概览
简要总结
In this project, investigators plan to develop a F-18 labeled molecular probe in order to detect the EGFR mutation tumor lessions in patients to identify patients benefiting fromTKIs treatment, and evaluate its efficacy in detecting EGFR Del 19 mutant lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male and female, aged 18-75 years old (including 18 and 75 years old), ECOG score 0 or
- •Patients could understand and sign the informed consent form voluntarily with good compliance.
- •Patients with histologically or cytologically or clinically confirmed lung cancer with measurable disease.
- •Women had to be using an effective contraceptive method (effective contraceptive means sterilisation, intrauterine hormonal devices, condoms, contraceptives/pills, sexual abstinence, or partner's removal of the vas deferens) during the study and for 6 months after the study. Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period.
- •Predicted survival greater than 3 months;
排除标准
- •Severe hepatic or renal dysfunction;
- •Pregnant or nursing;
- •Known allergy to the investigational drug or its excipients in study;
- •Unable to comply with the PET/CT imaging procedures;
- •Claustrophobia or other psychiatric disorders;
- •Other conditions deemed unsuitable for participation in the trial;
结局指标
主要结局
Standard Uptake Value Value
时间窗: 1 year
The standardized uptake value (SUV) of 18F-LF13 in EGFR mutation lesion measured by PET/CT
次要结局
未报告次要终点
研究者
研究点 (1)
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