2024-513843-10-00招募中2 期
68Ga-SATO in paediatric neuroblastoma patients; exploratory, safety, non-randomized, open label, comparative study - GAP NBL study
Prinses Maxima Centrum voor Kinderoncologie B.V.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月11日最近更新:
适应症
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
- 1
- 主要终点
- To assess the short term safety and tolerability of 68Ga-SATO, according to CTCAE v5.0.
研究概览
简要总结
Assess the short term safety and tolerability of 68Ga-SATO in pediatric patients with NBL
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 0-18 years
- •Written informed consent (by legal representative) and assent consent from the patient when applicable
- •Patients with a clinical suspicion of neuroblastoma who are referred for the first time for conventional M123IBGimaging and patients with known NBL who are referred for for follow-up M123IBG imaging
排除标准
- •Children with pre-existing severe auto-immune diseases.
- •Use of therapeutic long-acting somatostatin analogs (e.g. Sandostatin®, Lanreotide®) within the 21 days beforethe planned infusion of 68Ga-SATO
- •Use of diuretics within 24 hours before the planned infusion of 68Ga-SATO.
- •pregnancy of the patient
结局指标
主要结局
To assess the short term safety and tolerability of 68Ga-SATO, according to CTCAE v5.0.
To assess the short term safety and tolerability of 68Ga-SATO, according to CTCAE v5.0.
次要结局
- Comparison of 68Ga-SATO PET/CT imaging to the current clinical standard of M123IBG scintigraphy in NBL patients, in terms of lesions detection.
- Comparison of 68Ga-SATO PET/CT imaging to whole body MRI (in case available), in terms of lesions detection.
- To calculate, in a subset of patients, the radiation absorbed dose of 68Ga-SATO for patients using dynamic PET imaging.
- Evaluation of procedure time for the preparations and acquisition of a 68Ga-SATO
研究者
Arthur Braat
Scientific
Prinses Maxima Centrum voor Kinderoncologie B.V.
研究点 (1)
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