PET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Angiogenesis 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 angiogenesis PET/CT with the radioligand 68Ga-NODAGA- E[c(RGDyK)]2 in patients with neuroendocrine tumors (NETs).
详细描述
The radioligand 68Ga-NODAGA- E[c(RGDyK)]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/CT.
A total of 120 NET patients will be subjected to an angiogenesis-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-NODAGA-E[c(RGDyK)]2 (Standardized Uptake Values, SUVmax) 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
Experimental: Angiogenesis PET/CT
One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/CT
干预措施: One injection of 68Ga-NODAGA-E[c(RGDyK)]2 (Drug)
Experimental: Angiogenesis PET/CT
One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/CT
干预措施: PET/CT (Device)
结局指标
主要结局
Angiogenesis PET/CT imaging of patients with neuroendocrine tumors
时间窗: 1 hour
The radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 can be used to visualize neuroendocrine tumors (grade G1-G3)
次要结局
- Angiogenesis PET/CT progonostic factor for progression free survival(12 months)
- Angiogenesis PET/CT prognostic factor for overall and disease specific survival(12 months)
- Target validation of angiogenesis PET/CT(2 weeks)
研究者
Esben Carlsen
MD
Rigshospitalet, Denmark