NCT02826382已完成早期 1 期
A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Time course of uptake of [68Ga]P15-041 in bone metastases
研究概览
简要总结
A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical [99mTc]MDP scan
排除标准
- •Estimated creatinine clearance (GFR) < 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
研究组 & 干预措施
Dynamic imaging group
Experimental
Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041
干预措施: [68Ga]P15-041 (Drug)
Whole body dosimetry group
Experimental
Determination of human dosimetry of the investigation drug [68Ga]P15-041
干预措施: [68Ga]P15-041 (Drug)
结局指标
主要结局
Time course of uptake of [68Ga]P15-041 in bone metastases
时间窗: 60 minutes post injection
kinetics of \[68Ga\]P15-041 uptake in known or suspected bone metastases in prostate cancer
Time course of whole body distribution of [68Ga]P15-041
时间窗: 3 hours post injection
whole body distribution of \[68Ga\]P15-041 used for human dosimetry determination
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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