EUCTR2016-002279-88-NL进行中（未招募）1 期
The physiology of glucagon-like peptide-l receptor expression in patients with endogenous hyperinsulinism: correlation with histopathology - Exendin-CHI
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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 and clinically proven endogenous congenital hyperinsulinism:
- •- Unresponsive to medical treatment (diazoxide)
- •- Indication for 18F-DOPA PET/CT based on mutation analysis
- •- Standard imaging (18F-DOPA PETICT) not older than 8 weeks
- •- < 16 years old
- •- informed consent signed by parents or legal guardians of the patient.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Genetically proven diffuse CHI (presenting with a homozygous or compound heterozygous ABCCS/KCNJ11 mutation)
- •- Calculated creatinine clearance below 40 ml/min
- •- Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions based on CT)
- •- Age > 16 years
- •- No signed informed consent
研究者
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