TheraSphere Post-approval Study to Calculate the Radiation-absorbed Dose of Technetium-99m Macroaggregated Albumin (Tc-99m MAA) to the Whole Body and Non-liver Critical Organs.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Delivered Activity of Tc-99m MAA (MBq) for Whole Body
研究概览
简要总结
The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC).
详细描述
Every patient being treated with TheraSphere needs to have a screening procedure with the administration of a radioactive product named Tc-99m MAA (called pre-treatment mapping). This screening procedure aims to determine if the patient can be treated with TheraSphere. The purpose of this study is to better understand the dose of radiation that is absorbed by the body and the risk of Tc-99m MAA to the whole body and other organs around the liver. The study will determine the amount of Tc-99m MAA that stays in the body and organs up to 24 hours after the administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 21 years and older
- •Written informed consent
- •Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment.
排除标准
- •Patients who are contraindicated for TheraSphere treatment.
- •Patients who are contraindicated for Tc-99m MAA per the applicable Package Insert.
- •Patients who do not receive Tc-99m MAA during pre-treatment Y-90 mapping
结局指标
主要结局
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
时间窗: 4 hours +/- 2 hours
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
时间窗: 18-24 hours
To provide imaging data to calculate radiation delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.
时间窗: 4 hours +/- 2 hours
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Delivered Activity of Tc-99m MAA (MBq) for Whole Body.
时间窗: 18-24 hours
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection.
Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.
时间窗: Overall
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body.
Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs
时间窗: Overall
To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs.
Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs
时间窗: Overall
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs.
Effective Dose of Tc-99m MAA (mSv) Whole Body
时间窗: Overall
To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs.
Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body
时间窗: Overall
To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body.
次要结局
未报告次要终点