NCT01988272|CompletedDMC
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Sponsor study identifier
NIH
observational
33
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
January 2016
Actual (reported)The goal of this study is to develop imaging based methods to accurately determine the energy absorbed (absorbed dose) by tumor tissue and bone marrow after radioimmunotherapy with I-131 tositumomab . The administration of the radioactive, iodine-131 labeled, monoclonal antibody I-131 tositumomab, (also known as Bexxar) is part of the patient's clinical treatment protocol. For the absorbed dose measurement, investigators at the University of Michigan are evaluating a new Nuclear Medicine SPECT/CT imaging system . This new camera combines a CT imaging system in addition to a Nuclear Medicine SPECT scanner. CT scans allow the doctors to see a high quality picture of your internal organs. The Nuclear Medicine SPECT scanner allows the doctors to see the uptake of the radioactive I-131 including the tumor sites. The improved imaging using the SPECT/CT enables more accurate calculation of the energy absorbed by tumor tissue and bone marrow. Using the results from these calculations and clinical follow up data, the researchers will investigate the relationship between the absorbed dose to the tumor and the patient's tumor response as well as the relationship between the absorbed dose to the bone marrow and the bone marrow toxicity. These relationships can potentially be used in the future by doctors to help determine how much radioactive I-131 to administer to each patient to get optimal results.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 5, 2013
Actual (reported)November 20, 2013
Actual (reported)March 2015
Actual (reported)January 2016
Actual (reported)Correlation between radiation absorbed dose to tumor and response or progression free survival
Tumor absorbed doses will be calculated based on research SPECT/CT imaging and correlated with the response as assessed by clinical PET/CT.
6 months
Assess correlation between radiation absorbed dose to the bone marrow and hematologic toxicity.
6 months
Patients will undergo scanning on the above system.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of Non-Hodgkin Lymphomas
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Yuni Dewaraja, PhD
University of Michigan
33 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2013
First Posted
November 20, 2013
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2015
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
May 18, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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