NCT00162045已完成1 期
A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 16
- 主要终点
- Determination of the absorbed radiation dose of Sestamibi in subjects will be evaluated at the end of the study through measurements of PK (blood and urine) up to 8 hours, dosimetry for 8 hours and image biodistribution for up to 8 hours
研究概览
简要总结
The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been scheduled to undergo a clinically indicated rest or stress CARDIOLITE® MPI scan.
- •Be able to comply with imaging requirements permitting completion of rest or stress CARDIOLITE® whole-body scans and SPECT imaging procedures without the use of sedation.
排除标准
- •Have a terminal illness where expected survival is ≤6 months
- •Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).
结局指标
主要结局
Determination of the absorbed radiation dose of Sestamibi in subjects will be evaluated at the end of the study through measurements of PK (blood and urine) up to 8 hours, dosimetry for 8 hours and image biodistribution for up to 8 hours
时间窗: Following administration of Technetium Tc99m Sestamibi
次要结局
- A determination of the safety of Sestamibi will be evaluated at the end of the study through adverse and serious adverse events reported and evaluating vital signs, ECGs, physical exams and laboratory tests for each subject(Following administration of Technetium Tc99m Sestamibi)
研究者
研究点 (16)
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