Positron Emission Tomography (PET) Imaging of Patients With Low & Intermediate Grade Neuroendocrine Tumors Using 64Cu-SARTATE: A Single Centre, Open-Label, Non-Randomized, Phase-0 Microdosing Investigation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Incidence of adverse events related to 64Cu-SARTATE
研究概览
简要总结
The primary purpose of this study is to examine the safety and potential effectiveness of a drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age greater than or equal to 18 years
- •Life expectancy greater than or equal to 8 weeks
- •Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET)
- •At least one site of active somatostatin receptor positive malignancy, as demonstrated on the pre-study 68Ga-DOTATATE PET/CT scan performed as part of routine clinical care
- •Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
排除标准
- •Pregnant or breastfeeding females
- •Known sensitivity or allergy to somatostatin analogues
- •Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT & 64Cu-SARTATE PET/CT scan
- •Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product
- •Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product
- •QTc interval greater than 0.44seconds as measured by screening ECG
- •Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
- •Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
研究组 & 干预措施
Intervention
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.
干预措施: 64Cu-SARTATE (Drug)
结局指标
主要结局
Incidence of adverse events related to 64Cu-SARTATE
时间窗: 1 week post administration
Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.
Absorbed organ dose
时间窗: At 24 hours following administration
Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
Percentage of injected 64Cu-SARTATE dose found in organs of interest
时间窗: At 24 hours following administration
Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
次要结局
- Uptake in non-physiological, non-tumor containing tissues(30 minutes, 1 hour, 4 hours and 24 hours following administration)
- Demonstration of known malignancy(30 minutes, 1 hour, 4 hours and 24 hours following administration)