Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan (ZEVALIN-SDUI)

November 22, 2011 updated by: Bayer

Special Drug Use Investigation of Zevalin

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Many Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population of this study is 40 patients who received In-111 Zevalin to access biodistribution of Zevalin.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Patients who have received In-111 Zevalin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
At 48-72 hours after In-111 Zevalin injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 24, 2011

Study Record Updates

Last Update Posted (Estimate)

November 24, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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