Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan

Bayer72 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-Hodgkin's Lymphoma (NHL)

Interventions

[111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)DRUG

Patients who have received In-111 Zevalin.

Eligibility

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Many Locations, Japan

Outcomes

Primary Outcomes

Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]

Time frame: 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]

Time frame: At 48-72 hours after In-111 Zevalin injection

Data from ClinicalTrials.gov

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