Preparation of 5T4 Tumor Novel Target Nanobody PET Probe and Clinical Translation in Lung Cancer
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
研究概览
简要总结
This study aims to evaluate a novel 5T4 targeted nanobody PET imaging tracer, 68Ga-MY, for the detection and evaluation of solid tumors.
The 5T4 oncofoetal antigen is considered a valuable tumor-associated antigen, which is expressed in many different cancers, but is rarely expressed in normal adult tissues. And cell surface expression of 5T4 is an important property for antibody-targeted therapies. It has been shown that 5T4 is expressed on tumour-initiating cells (TICs) and associated with worse clinical outcome. Moreover, decreased adherence due to 5T4 expression may be associated with cancer spread.
In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-MY. The imaging results will be compared with 18F-FDG. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-MY PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with solid tumors;
- •Presence of measurable lesions on imaging examinations;
- •Expected survival ≥12 weeks.
排除标准
- •Severe hepatic or renal dysfunction;
- •Women who are planning pregnancy, pregnant, or breastfeeding;
- •Unable to remain in supine position for 30 minutes;
- •Refusal to participate in this clinical study;
- •Diagnosis of claustrophobia or other psychiatric disorders;
- •Other conditions deemed by the investigator as inappropriate for participation in the trial.