Study to Calculate the Radiation-Absorbed Dose of Technetium-99m Macroaggregated Albumin (99mTc-MAA) to the Whole Body and Non-Liver Critical Organs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mean Absorbed Dose (Gy) for the Whole Body
研究概览
简要总结
The goal of this interventional clinical trial is to evaluate the dose of radiation of Technetium-99m macroaggregated-albumin (99mTc-MAA) after an intra-arterial injection to the whole body and non-liver critical organs in patients who are undergoing evaluation for SIR-Spheres treatment for hepatocellular carcinoma.
详细描述
The investigation is a prospective, single center, open label, single-arm study. Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA injection, the final of which will occur between 18 and 24 hours post-injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Willing, able, and mentally competent to provide written informed consent
- •Age 18 or older at the time of consent
- •Patients who are being evaluated for SIR-Spheres treatment eligibility
排除标准
- •Patients who are contraindicated for SIR-Spheres treatment
- •Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert
研究组 & 干预措施
99mTc-MAA Injection
Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.
干预措施: 99mTc-Macro Albumin Aggregate (Drug)
结局指标
主要结局
Mean Absorbed Dose (Gy) for the Whole Body
时间窗: 18-24 hours
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
时间窗: 18-24 hours
Mean Activity (Bq) for the Whole Body
时间窗: 18-24 hours
Mean Activity (Bq) for Critical Non-liver Organs
时间窗: 18-24 hours
Effective Dose (Gy) for the Whole Body
时间窗: 18-24 hours
次要结局
未报告次要终点