Imaging Based Dosimetry for Individualized Internal Emitter Therapy

Completed

• Conditions: Non-Hodgkin's Lymphoma

• Registration Number: NCT01988272
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Primary Completion: 2015-03
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• • Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of Non-Hodgkin Lymphomas

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Exclusion Criteria

• • Clinical instability

  • Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed
  • Refusal to provide informed consent
  • Patients who are pregnant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between radiation absorbed dose to tumor and response or progression free survival	6 months	Tumor absorbed doses will be calculated based on research SPECT/CT imaging and correlated with the response as assessed by clinical PET/CT.

Secondary Outcome Measures

Name	Time	Method
Assess correlation between radiation absorbed dose to the bone marrow and hematologic toxicity.	6 months	Absorbed dose will be determined by SPECT/CT imaging of the marrow rich lumbar region and will be correlated with toxicity based on follow-up blood counts.

Trial Locations

Locations (1)

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States