NCT05321316招募中不适用
Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
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: 2026年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Standardized uptake value（SUV）
研究概览
简要总结
To evaluate the ability of [68Ga]N188 to detect nectin-4 overexpression in patients with urothelial carcinoma, especially in patients with recurrent or advanced bladder 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years old, male or female;
- •Heart function is normal;
- •Normal heart function;
- •Estimated survival ≥12 weeks;
- •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 starting 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;
- •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.
排除标准
- •Serious abnormality of liver, kidney and blood;
- •Pregnant patients;
- •Pregnant and lactation women;
- •3) 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
68Ga-N188
Experimental
Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-N188 PET/CT scan.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Standardized uptake value（SUV）
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 （68Ga-N188） in urothelial carcinoma 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
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung LesionsLung Cancer, Non-Small CellLung InfectionNCT06648317Peking University Cancer Hospital & Institute20
招募中
不适用
68Ga-N188 PET/CT Imaging in MalignancyNeoplasmsNCT05593107Peking University First Hospital203
进行中（未招募）
不适用
68Ga-DOTANOC as a PET tool to diagnose nueroendocrine tumors - NDStudy of tumor neuroendocrin originEUCTR2010-022975-67-ITAZIENDA U.L.S.S. N.8 DI ASOLO
Unknown
早期 1 期
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of NesidioblastosisNesidioblastosisInsulinomaNCT02560376Peking Union Medical College Hospital100
尚未招募
不适用
Nectin-4 Targeting ADC Probe for PET Imaging in Solid TumorsSolid TumorNCT05322512Peking University Cancer Hospital & Institute20