Trial Condition(s):
Non-Hodgkin's Lymphoma (NHL)
Zevalin post-marketing surveillance for adequateness of image interpretation criteria in Japan (ZEVALIN-SDUI)
Bayer Identifier:
15043
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Patients who received In-111 Zevalin to verify that expected biodistribution is present.
Exclusion Criteria
- Patients who are contraindicated based on the product label.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Special drug use investigation of Zevalin
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]Timeframe: 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]Timeframe: At 48-72 hours after In-111 Zevalin injection
Additional Information
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