Clinical trial · Observational
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan
Special Drug Use Investigation of Zevalin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Primary outcomes (2)
- measure
- 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
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available