68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
详细描述
68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The investigators will determine the use of 68Ga-NOTA-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging. GLP-1R imaging, specifically expressed on pancreatic beta cell surface, might help with diagnosis of different types of nesidioblastosis (ie. focal or diffuse type), and may improve the treatment strategy of nesidioblastosis. The investigator will determine the use of 68Ga-NOTA-exendin-4 PET/CT in differentiating nesidioblastosis.
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
- 6 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad.
- •Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration <3.0 mM, insulin >3 µU/ml, and C-peptide >0.6 ng/ml).
- •Conventional imaging within 1 month
- •Signed written consent
- •Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study)
排除标准
- •Pregnancy
- •Breastfeeding
- •Renal function: serum creatinine > 3.0 mg/dl
- •Known allergy against exendin-4
- •Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
研究组 & 干预措施
68Ga-NOTA-exendin-4 PET/CT
The patients were injected with 55.5-111 MBq of 68Ga-NOTA-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 30-60 min later.
干预措施: 68Ga-NOTA-exendin-4 (Drug)
结局指标
主要结局
Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis
时间窗: 1 year
次要结局
- Adverse events collection(1 week)