uPAR-PET/MRI in Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- uPAR PET/MRI prognostic factor for overall survival
研究概览
简要总结
The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of glioblastoma.
详细描述
68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/MRI will be applied in patients suspected of glioblastoma multiforme. The uptake of the radioligand 68Ga-NOTA-AE105 will be compared and correlated with expression of the molecular target: uPAR using immunohistochemistry of tumor tissue samples obtained during routine stereotactic biopsies or operation. In addition, the semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in tumor tissue will be correlated with overall survival and progression free survival
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients where imaging with MRI or CT is suspicious of having glioblastoma multiforme, and patients, and who is referred for stereotactic biopsy, chemotherapy or surgery
- •The participants must be capable of understanding and giving full informed written consent
- •age above 18 years
排除标准
- •Pregnancy
- •Lactation/breast feeding
- •Age above 85 years old
- •Weight above 140 kg
- •Known allergy towards 68Ga-NOTA-AE105
研究组 & 干预措施
uPAR PET/MRI
One injection of 68Ga-NOTA-AE105 followed by PET/MRI.
干预措施: One injection of 68Ga-NOTA-AE105 (Drug)
uPAR PET/MRI
One injection of 68Ga-NOTA-AE105 followed by PET/MRI.
干预措施: PET/MRI (Device)
结局指标
主要结局
uPAR PET/MRI prognostic factor for overall survival
时间窗: 36 months
Patients will be followed for 36 months after uPAR/PET MRI
uPAR PET/MRI imaging of uPAR expression
时间窗: 1 hour
Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/MRI scan performed within 1 hour following injection of 68Ga-NOTA-AE105, compared with immunohistochemistry of uPAR (semiquantitative)
次要结局
- uPAR PET/MRI prognostic factor for progression free survival(36 months)
研究者
Dorthe Skovgaard
Principal investigator, MD, Phd
Rigshospitalet, Denmark