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临床试验/EUCTR2014-003167-38-NL
EUCTR2014-003167-38-NL进行中(未招募)1 期

68Ga-NODAGA-exendin-4 PET/CT in patients with AHH - a prospective comparative evaluation of preoperative imagingUnder the FP7 project Betacure (602812); Personalized diagnosis and treatment of hyperinsulinemic hypoglycaemia caused by betacell pathology - GLP-l-AHH

Radboudumc0 个研究点目标入组 56 人开始时间: 2015年1月7日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Radboudumc
入组人数
56

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic symptoms in the fasting state with low plasma glucose, inappropriately high serum insulin and C-peptide concentrations
  • Signed informed consent
  • Standard imaging not older than 8 weeks. This includes a triple-phase CT or MRI, somatostatin receptor imaging (68Ga-DOTATOC, 68Ga-DOTATATE or 111In-DTPA-octreotide SPECT/CT) and endocopic ultrasound (EUS). Protocols that should be followed for these procedures can be found in the annex.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 56
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Breast feeding
  • Pregnancy or the wish to become pregnant within 6 months
  • Calculated creatinine clearance below 40ml/min
  • Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions)
  • Age < 18 years
  • No signed informed consent

研究者

发起方
Radboudumc

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