Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism
研究概览
简要总结
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.
详细描述
For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any age, but primarily infants 0-6 months.
- •Children with confirmed diagnosis of congenital hyperinsulinism.
排除标准
- •Cases in which surgery will not be considered by parents or guardians.
研究组 & 干预措施
Subjects who had PET and surgery
Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.
干预措施: F-DOPA (Drug)
Subjects who had PET and surgery
Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.
干预措施: PET scan (Radiation)
结局指标
主要结局
The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism
时间窗: up to 1 month post surgical intervention
Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse
次要结局
- Safety of F-DOPA PET(72 hours maximum or prior to pancreatic surgery)
研究者
Lisa States
Attending Physician/Radiologist
Children's Hospital of Philadelphia