Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- SUV (Standardized Uptake Value)
研究概览
简要总结
To study the normal physiological distribution of the probe 124I-EV in human body and its ability to detect overexpression of Nectin-4 in tumor lesions.
详细描述
Nectin-4 is highly expressed in different types of cancer and is involved in various aspects of tumor proliferation, angiogenesis, metastasis, tumor recurrence, and DNA repair. Therefore, the development of nuclear medicine molecular probes targeting Nectin-4 is of great significance for improving the specificity and accuracy of Nectin-4 related cancer diagnosis.
EV (Enfortumab vedotin) is the first and only drug targeting Nectin-4 so far. By exploring the diagnostic efficacy of 124I-EV in tumors with high nectin-4 expression, it will not only provide evidence for the early diagnosis of tumors. At the same time, the Nectin-4 expression in tumors can be used to develop effective and precise treatment for patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old, male or female;
- •Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
- •The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.
- •Normal heart function;
- •Good follow-up compliance;
- •presence of at least one measurable target lesion according to RECIST1.1 criteria
- •Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before the start of the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test.
排除标准
- •Serious abnormality of liver, kidney and blood;
- •Pregnant patients;
- •Pregnant and lactation women;
- •unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.
研究组 & 干预措施
124I-EV
Imaging cohort All enrolled participants will be allocated to undergo three 124I-EV PET/CT scans.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
SUV (Standardized Uptake Value)
时间窗: 2 years
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （124I-EV） in tumor lesions by measuring SUV on PET/CT.
次要结局
未报告次要终点
研究者
Hua Zhu
Professor
Peking University Cancer Hospital & Institute