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:

NCT01479387

EudraCT Number:

Not Available

Study Completed

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
72
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Zevalin (Ibritumomab tiuxetan, BAY86-5128)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design