Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Standardized uptake value
研究概览
简要总结
Glucagon-like peptide-1 receptor (GLP-1R) is a kind of G protein coupled receptor which regulate the insulin secretion and serves as potential target in the diagnosis of functional pancreas neuroendocrine tumor. The aim of this study was the clinical evaluation of a potential GLP-1R targeted tracer 68Ga-NOTA-MAL-Cys39-exendin-4 for the detection of insulinoma.
详细描述
Since GLP-1R is expressed in human β-cells and highly overexpressed in insulinomas，multiple GLP-1R-targeted radiopharmaceuticals were devoted to insulinoma localization imaging.68Ga-NOTA-MAL-Cys39-exendin-4 is an optimal probe targeting GLP-1R. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-MAL-Cys39-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.The investigators will determine the use of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient volunteers and signs an informed consent form.
- •age ≥18 and ≤75 years old;
- •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 3 month.
排除标准
- •Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;
- •Breast feeding;
- •Pregnancy or the wish to become pregnant within 6 months;
- •Renal function: serum creatinine > 3.0 mg/dl;
- •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-MAL-Cys39-exendin-4 PET/CT
The patients were injected with 111-185 MBq of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 60 min later.
干预措施: 68Ga-NOTA-MAL-Cys39-exendin-4 (Drug)
结局指标
主要结局
Standardized uptake value
时间窗: 1 year
Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma
次要结局
- Incidence of Adverse Events(Adverse events within 1 week after the injection and scanning of patients will be followed and assessed)
- GLP-1 receptor expression by histology compared to tracer uptake(1 year)
研究者
FengWang
Director of Nuclear Medicine
Nanjing First Hospital, Nanjing Medical University