check_circleStudy Completed
Non-Hodgkin's Lymphoma (NHL)
Bayer Identifier:
15043
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Zevalin post-marketing surveillance for adequateness of image interpretation criteria in Japan
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.
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
72Trial Dates
August 2008 - February 2011Phase
N/ACould I Receive a placebo
NoProducts
Zevalin (Ibritumomab tiuxetan, BAY86-5128)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]date_rangeTime Frame:At 48-72 hours after In-111 Zevalin injectionenhanced_encryptionNoSafety Issue:
- Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No]date_rangeTime Frame:At 48-72 hours after In-111 Zevalin injectionenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A