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

NCT01479387 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2011-11-24

No results posted yet for this study

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.

Conditions

  • Non-Hodgkin's Lymphoma (NHL)

Interventions

DRUG

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

Patients who have received In-111 Zevalin.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Completion
2011-02-28

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479387 on ClinicalTrials.gov