Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Correlation between the tracer uptake (counts) and beta cell mass (mg)
研究概览
简要总结
The main goal is to study the correlation of pancreatic uptake of In-111-DTPA-exendin-4 (measured by ex vivo counting) with the beta cell mass determined in the pancreatic specimens obtained after surgery.
详细描述
In order to fully characterize the highly promising tracer In-111-DTPA-exendin-4 in humans, quantitative SPECT imaging will be correlated to the ex vivo tracer distribution in patients undergoing pancreatectomy or a Whipple procedure. In vivo imaging will be combined with post-pancreatectomy (micro)autoradiography, measurement of In-111-DTPA-exendin-4 concentrations in the pancreas using a gamma counter and morphometric determination of the actual beta cell mass. By this means, the relation between tracer uptake and beta cell mass in non-diabetic patients and T2D patients will be established. These highly relevant data will allow the improvement of the interpretation of clinical quantitative SPECT data in subsequent studies in patients with T1D and T2D. In addition, high uptake has been observed in the duodenum/pyloric area in patients in an ongoing study. At this point in time, it remains unclear which cells are responsible for this uptake. It would be of great interest to identify the GLP-1R positive cells in order to better understand the physiological actions of GLP-1 agonists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Scheduled for partial or complete pancreatectomy or Whipple procedure at Radboudumc
排除标准
- •Resection that provides insufficient amount of tissue
- •Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl- Peptidase IV inhibitors
- •Breast feeding
- •Pregnancy or the wish to become pregnant within 6 months
- •Renal disease
- •Liver disease
- •Age < 18 years
研究组 & 干预措施
Scheduled for (partial) pancreatectomy or Whipple procedure
I.v. injection with In-111-DTPA-exendin-4 and SPECT/CT scan
干预措施: indium-111-exendin SPECT/CT (Radiation)
结局指标
主要结局
Correlation between the tracer uptake (counts) and beta cell mass (mg)
时间窗: 4 years
The primary objective is the correlation between the ex vivo In-111-exendin tracer accumulation in the pancreas (counts) of patients undergoing pancreatectomy or Whipple procedure, and the beta cell mass (mg) in non- diabetic patients and patients with diabetes.
次要结局
未报告次要终点