Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan
Completed
- Conditions
- Non-Hodgkin's Lymphoma (NHL)
- Interventions
- Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- Registration Number
- NCT01479387
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Patients who received In-111 Zevalin to verify that expected biodistribution is present.
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Exclusion Criteria
- Patients who are contraindicated based on the product label.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128) -
- Primary Outcome Measures
Name Time Method Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No] 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] At 48-72 hours after In-111 Zevalin injection
- Secondary Outcome Measures
Name Time Method