Evaluation of 68Ga-DOTATOC PET/CT-enterography for the Detection of the Primary Lesion in Neuroendocrine Tumors of the Small Bowel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Evaluation of predictive role of CT-Enterography and 68Ga-DOTATOC PET/CT in detecting siNETs
研究概览
简要总结
The neuroendocrine neoplasms of the small intestine (Si-NENs) is a relatively rare malignancy. Surgical resection is the only curative treatment for the early-stage. It remains controversial its application for advanced metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
The identification of metastatic disease and tumor grade are the most important prognostic factors in advanced GEPNETs. Therefore, precise staging and evaluation of disease burden with a reliable imaging method is crucial for determining the correct stage of the disease and consequently the correct treatment.
A unique feature of NeuroEndocrinal Tumors (NETs) is the expression of somatostatin receptors (SSTR) which can be targeted with radiolabeled peptides for imaging.
The Positron Emission Tomography-Computed Tomography (PET/CT) technique using somatostatin analogs labeled with the positron emitting isotope, 68Ga (68Ga-DOTA peptides), has been shown to offer advantages over conventional imaging modalities as well as additional important quantitative and qualitative diagnostic information.
The aim of this study is to calculate the sensitivity (SE), the specificity (SP), the positive and negative predictive values (PPV and NPV) and the overall accuracy of 68Ga-DOTATOC PET/CT-enterography in detecting in primary lesion and multifocality of siNETs.
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
- •patients with small bowel neuroendocrine tumours
- •tumors with any grade (from 1 to 3) and any Ki 67 percentage
- •patients eligible for surgical resection
排除标准
- •patients with synchronous other oncological disease
- •patients with Inflammatory bowel disease
- •patients Not eligible for surgery
结局指标
主要结局
Evaluation of predictive role of CT-Enterography and 68Ga-DOTATOC PET/CT in detecting siNETs
时间窗: 3 months
Proportion of the true positive patients at diagnostic procedure considering the pathology results as the gold standard.
次要结局
未报告次要终点
