PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Malignant glioma uptake of 68Ga-DOTATOC
研究概览
简要总结
The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Age: 18 to 70 years old
- •Language spoken: Finnish or Swedish
- •Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- •Supratentorial malignant glioma based on MRI imaging
- •Supratentorial recurrent glioma based on MRI and/or [11C]methionine PET imaging
- •Patients must be able to understand the meaning of the study and sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff
排除标准
- •Any medical or psychiatric condition that compromises the subject´s ability to participate in the study
- •Any other significant disease including liver or renal disease
- •Pregnant or lactating women
研究组 & 干预措施
68Ga-DOTATOC
干预措施: [68Ga]DOTATOC (Drug)
结局指标
主要结局
Malignant glioma uptake of 68Ga-DOTATOC
时间窗: within 90 minutes post-injection
PET/CT imaging of the brain starts immediately after the intravenous bolus injection of 68Ga-DOTATOC. Dynamic PET/CT imaging is done over 60-min. A late 90-min scan will be obtained for selected patients. PET studies are analyzed by determining the Standardized Uptake Values (SUV) of the tumor using regions of interest (ROI) drawn both manually and automatically on the tumor.
次要结局
- Immunohistochemical SST2 receptor status of the tumor specimen(After glioma surgery within 4 weeks of PET/CT imaging)
研究者
Heikki Minn
Chief Physician
Turku University Hospital