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临床试验/NCT03785236
NCT03785236终止不适用

Visualizing Beta Cells After Intrahepatic Islet of Langerhans Transplantation

Radboud University Medical Center2 个研究点 分布在 2 个国家目标入组 13 人开始时间: 2016年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
2
主要终点
Hepatic uptake of 68Ga-NODAGA-exendin-4

研究概览

简要总结

In patients with type 1 diabetes (T1D) that have undergone islet of Langerhans transplantation or are on the waiting list for transplantation, Ga-68-exendin PET imaging is performed to study the visualization of transplanted islet grafts in patients.

详细描述

Detecting damage to islets with a reliable imaging technique could be important for improving islet survival after transplantation. This could lead to better patient outcomes which would be of great interest for the treatment of type 1 diabetes. In order to assess the possibility of visualizing transplanted islet grafts with Ga-68-NODAGA-exendin-4 PET, a proof-of -concept study is performed in 10 patients with type 1 diabetes who have undergone intrahepatic islet transplantation with biochemically proven functional islet grafts and 5 patients with type 1 diabetes who are on the waiting list for islet transplantation. The investigators propose to determine the uptake of the radiolabeled tracer and compare it to functionality of the islet grafts. These highly relevant data will provide us with more information on the suitability of GLP-1 receptor imaging for monitoring of transplanted islet mass.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Treatment with synthetic exendin or Dipeptidyl-Peptidase IV inhibitors within the last 3 months
  • Breast feeding
  • Pregnancy or the wish to become pregnant within 6 months
  • Kidney disease
  • Liver disease
  • Age <18 years
  • No signed informed consent
  • Exclusion criteria for MR:
  • fragments, clips or devices in brain, eyes, spinal canal
  • Implantable defibrillator or pacemaker (wires)
  • Mandibular magnetic implants
  • Neurostimulator, bladder stimulator, non-removable insulin pump
  • Metal tissue-expander in chest
  • Cochlear implant
  • Ossicular replacement prosthesis

结局指标

主要结局

Hepatic uptake of 68Ga-NODAGA-exendin-4

时间窗: 1 year

Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis

次要结局

  • Islet graft function(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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