ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients
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
- 2
- 主要终点
- Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma
研究概览
简要总结
This study aims to investigate 68Ga-MY6349, an immune-PET tracer targeting trophoblast cell surface antigen 2 (Trop2), for the noninvasive diagnosis of craniopharyngioma in vivo.
详细描述
The trophoblast cell surface antigen 2 (Trop2), encoded by the TACSTD2 gene, is a transmembrane glycoprotein that regulates epithelial malignant transformation and proliferation. Trop2 has been reported to be overexpressed in various epithelial tumors, including craniopharyngioma. 68Ga-MY6349, an immune-PET tracer targeting Trop2, has demonstrated high specificity and sensitivity in visualizing other Trop2-high solid tumors. In this research, patients with primary or recurrent craniopharyngioma scheduled for surgery will receive the preoperative 68Ga-MY6349 PET/CT in addition to standard MRI. Tumor uptake is quantified by the maximum standardized uptake value (SUVmax). The diagnostic performance of 68Ga-MY6349 PET is subsequently compared with MRI and the SUVmax is correlated with Trop2 expression levels in postoperative pathological specimens.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be able to provide a written informed consent
- •radiologically presumed and/or histologically confirmed craniopharyngioma scheduled for resection
- •adequate clinical condition (Karnofsky performance status ≥70)
排除标准
- •concomitant major central nervous system disorders
- •severe hepatic or renal dysfunction
- •history of severe allergy or hypersensitivity to intravenous radiographic contrast agents
- •claustrophobia precluding PET/CT or MRI examinations
- •pregnancy or breastfeeding
结局指标
主要结局
Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma
时间窗: Within 1 week after PET imaging.
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in craniopharyngioma will be measured.
Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma
时间窗: Within 1 week after PET imaging.
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in craniopharyngioma will be measured.
次要结局
- Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in craniopharyngioma.(Within 2 week after surgery.)
- Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in craniopharyngioma.(Within 2 week after surgery.)
研究者
Deling Li
Professor
Beijing Tiantan Hospital