PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- uPAR PET/CT imaging of patients with neuroendocrine tumors
研究概览
简要总结
The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with neuroendocrine tumors (NETs).
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. A total of 120 NET patients will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET.
- •WHO performance status 0-2
- •Must be able to read and understand the patient information in Danish and to give informed consent
排除标准
- •Pregnancy
- •Breast-feeding
- •Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
- •History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E[c(RGDyK)]2
- •In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)
研究组 & 干预措施
uPAR PET/CT
One injection of the radioligand 68Ga-NOTA-AE105
干预措施: One injection of 68Ga-NOTA-AE105 (Drug)
uPAR PET/CT
One injection of the radioligand 68Ga-NOTA-AE105
干预措施: PET/CT (Device)
结局指标
主要结局
uPAR PET/CT imaging of patients with neuroendocrine tumors
时间窗: 1 hour
The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3)
次要结局
- uPAR PET/CT prognostic factor for progression free survival(12 months)
- uPAR PET/CT prognostic factor for overall and disease specific survival(12 months)
研究者
Esben Carlsen
Principle investigator, Medical doctor
Rigshospitalet, Denmark