Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Accrual rate
研究概览
简要总结
Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Staging of the disease can be done by different imaging strategies (CT, MRI, scintigraphy and PET/CT). Discrepancies may be observed among these different strategies resulting in different treatment strategies. The goal of this study is to assess the feasibility and safety of 68Ga-DOTATATE and to compare it to 123I-MIBG when investigating neuroblastoma.
详细描述
Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.
Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.
Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot
Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.
Study population: Children and adults with biopsy-proven or suspected neuroblastoma
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly suspected or biopsy-proven neuroblastoma or recurrence of neuroblastoma
- •Planned 123I-MIBG imaging
- •Able and willing to provide signed informed consent in French or English (for the adult candidates or the parent/legal tutor of the pediatric candidates)
- •Aged between 1 day and 21 years old (inclusively).
排除标准
- •History of another cancer in the past 5 years other than non-melanomatous skin cancer.
- •Currently under a randomized control trial with unknown allocation;
- •Currently under treatment;
- •Medical/surgical intervention on the tumour between 123I-MIBG and 68Ga-DOTATATE PET/CT scan.
- •Medically unstable or unable to undergo scan.
- •Pregnancy (breastfeeding is not an exclusion criterion but needs to be stopped for at least 12 hours after 68Ga-DOTATATE injection).
- •Prior allergic reaction to somatostatin analogues
研究组 & 干预措施
Single arm with 68Ga-DOTATATE
all participants will undergo a PET scan with 68Ga-DOTATATE
干预措施: Radiopharmaceutical 68Ga-DOTATATE (Biological)
结局指标
主要结局
Accrual rate
时间窗: For the duration of the study, lasting 6 years
Number of participants enrolled / year
Rate of adverse events
时间窗: Up to 24 hours following injection of 68Ga-DOTATATE
Number of adverse events (being serious or not) associated to the intervention (injection of 68Ga-DOTATATE and PET/CT acquisition
次要结局
- Positive lesions for 68Ga-DOTATATE(One hour post-injection of 68Ga-DOTATATE)
- Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG(Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan))