NCT03042416已完成3 期
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Immediate safety evaluation
研究概览
简要总结
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations:
- Pediatric patients with congenital hyperinsulinism
- Pediatric patients with neuroblastoma
- Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor
- Adult patients with a clinical suspicion of Parkinson's disease
- Pediatric or Adult patients with primary brain tumors
This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (less than 17 years old) with congenital hyperinsulinism
- •Pediatric patients (less than 17 years old) with neuroblastoma
- •Pediatric patients (less than 17 years old) or Adult patients (17 or older) with known or clinically suspected neuroendocrine tumor outside of the pancreas
- •Adult patients (17 or older) with a clinical suspicion of Parkinson's disease.
- •Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors
排除标准
- •Unable to obtain consent
- •Weight > 250 kg (weight limitation of PET/CT scanner)
- •Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan
- •Young pediatric patients (less than 10 years old) who are unable to lie flat for 20-30 minutes and for whom clinical sedation is contraindicated (as determined by a pediatric anaesthesiologist)
- •Pregnancy
- •Lack of intravenous access
研究组 & 干预措施
18F-DOPA scan
Experimental
18F-DOPA (4 MBq/kg, minimum 110 MBq, maximum 600 MBq) intravenous. Single-dose 20-80 minutes prior to PET/CT scan of brain or whole body (depending on specific imaging protocol for patient).
干预措施: 18F-DOPA (Drug)
结局指标
主要结局
Immediate safety evaluation
时间窗: Within 1 hour of injection
Clinical screen for adverse reactions to 18F-DOPA injection
次要结局
- Delayed safety evaluation - referring physician(6 months after injection)
- Delayed safety evaluation(10-14 days after injection)
- Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected(Within 3 days after injection)
- Perceived clinical benefit(6 months after injection)
研究者
研究点 (1)
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