68Ga-NOTA-RM26 PET/CT in Glioma Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SUVmax
研究概览
简要总结
The aim of this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT).
详细描述
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to assess its clinical diagnostic value in patients with glioma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected or confirmed untreated glioma patients
- •signed written consent.
排除标准
- •pregnancy
- •breastfeeding
- •known allergy against Pentixafor
- •any medical condition that in the opinion of the investigator,may
- •significantly interfere with study compliance
研究组 & 干预措施
68Ga-RM26, PET/CT
Inject 68Ga-Pentixafor and then perform PET/CT scan.
干预措施: 68Ga-RM26 (Drug)
结局指标
主要结局
SUVmax
时间窗: through study completion, an average of 1.5 years
SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT.
次要结局
未报告次要终点