Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation: Monocentric Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL
研究概览
简要总结
18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography) imaging using peptide receptors has gained an increasing role in the management of NETs. The use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of SSTRs-expressing tumors, including PGLs.
In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and 68Ga-DOTATATE PET-CT have never been compared in this clinical setting.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PHEO or PGL: initial staging or restaging
- •Reference imaging within the last 2 months: multiphasic cervico-thoracoabdominal CT scan, 18F-FDOPA PET-CT and head and neck MRI (if head and neck localization
排除标准
- •Pregnant or breast-feeding woman
结局指标
主要结局
interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL
时间窗: 7 months
The primary outcome measure is to determine the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL. We will document the number of additional foci detected by 68Ga-DOTATATE PET-CT compared to 18F-FDOPA PET-CT.
次要结局
- assesment of 68Ga-DOTATATE PET-CT to anatomical imaging(7 months)