The Evaluation of the 6-[18F]Fluoro-levo-dopa and 123I-MIBG Uptake in the Patients With Neuroblastoma
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The maximum standardized uptake value and tumor-to-liver uptake ratio
研究概览
简要总结
Neuroblastic tumors are childhood neoplasms that possess amino acid decarboxylase (AADC) activity and Meta-iodobenzylguanidine(MIBG), they can theoretically be imaged by (18)F-fluorodihydroxyphenylalanine ((18)F-FDOPA) and (123)I-Meta-iodobenzylguanidine((123)I-MIBG) PET, they are new and specific diagnostic and follow-up tools for neuroendocrine tumors. In this study, we explored the accuracy and clinical role of (18)F-FDOPA and (123)I-MIBG PET in neuroblastic tumors.
METHODS:
Patients with tissue-proven neuroblastic tumors receiving (18)F-FDOPA PET or (123)I-MIBG at initial diagnosis or during follow-ups were enrolled. The sensitivity and specificity of (18)F-FDOPA or (123)I-MIBG PET were compared to each other and compared to(18)F-FDG PET, using tumor histology as the standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Diagnosed by clinical criteria(one of below)
- •Proved as Neuroblastoma by a pathological section
- •Bone meta with 24 hrs urine VMA(Vanillylmandelic acid )or HVA (Homovanillic acid) elevated
- •CT or MRI found tumor around adrenal gland or Neuroblastic tumor
- •(2) Age between 0-30 years old，Body weight over 2.5kg
- •(3) Signed Inform Consent Form
排除标准
- •(1)AST and ALT > 200U/L、Cre > 2.5mg/dl
- •(2)Allerg to 18F-dopa、123I-MIBG
- •(3)Subject not fit this study(assessed by PI)
- •(4)No more need to arrenge PET because disease progress, assessed by VS
结局指标
主要结局
The maximum standardized uptake value and tumor-to-liver uptake ratio
时间窗: Outcome will be measured in one week after performed.
The maximum standardized uptake value and tumor-to-liver uptake ratio will be evaluated by specific Nuclear Medicine doctor.
次要结局
未报告次要终点