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Completed

NCT Number: NCT01479387

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

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma (NHL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Patients who have received In-111 Zevalin.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Special Drug Use Investigation of Zevalin

Acronym: ZEVALIN-SDUI

Important dates

Study start
2008
Study completion
2011
First posted
Nov 24, 2011
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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