Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
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.