试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 72
- 主要终点
- Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]
研究概览
简要总结
This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received In-111 Zevalin to verify that expected biodistribution is present.
排除标准
- •Patients who are contraindicated based on the product label.
研究组 & 干预措施
Group 1
干预措施: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128) (Drug)
结局指标
主要结局
Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]
时间窗: At 48-72 hours after In-111 Zevalin injection
Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No]
时间窗: At 48-72 hours after In-111 Zevalin injection
次要结局
未报告次要终点