2022-501694-39-01招募中2 期
A Prospective Study Comparing [18F]mFBG PET-CT to [123I]mIBG Scanning in Neuroblastoma
Princess Maxima Center For Pediatric Oncology1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年9月23日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Detected skeletal lesions on [18F]mFBG PET-CT and [123I]mIBG scanning
研究概览
简要总结
To compare the diagnostic performance of [18F]mFBG PET-CT to conventional [123I]mIBG SPECT-CT for the detection of skeletal lesions in patients with neuroblastoma
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient with (a clinical suspicion of) neuroblastoma who is referred for conventional [123I]mIBG imaging
- •Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations
排除标准
- •[18F]mFBG imaging cannot be scheduled within two weeks of [123I]mIBG imaging
- •Pregnancy of patient
结局指标
主要结局
Detected skeletal lesions on [18F]mFBG PET-CT and [123I]mIBG scanning
Detected skeletal lesions on [18F]mFBG PET-CT and [123I]mIBG scanning
次要结局
- Detected soft tissue lesions on [18F]mFBG and [123I]mIBG scanning
- Radiation absorbed doses (mSv) for organs and tumour of [18F]mFBG imaging
- Mean difference in number of detected lesions and limits of agreement, Cohen’s kappa
- SUVmean for normal organs, SUVmax for tumour lesions
研究者
Prof. Dr. G.A.M. Tytgat
Scientific
Princess Maxima Center For Pediatric Oncology
研究点 (1)
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