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Completed

NCT Number: NCT01988272

Imaging Based Dosimetry for Individualized Internal Emitter Therapy

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Treatment and study plan

SPECT/CT imaging

Device

Patients will undergo scanning on the above system.

Other names: Siemens Symbia SPECT/CT system

Primary outcomes

  1. Correlation between radiation absorbed dose to tumor and response or progression free survival

    Time frame: 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 outcomes

  1. Assess correlation between radiation absorbed dose to the bone marrow and hematologic toxicity.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Nov 20, 2013
Registry last updated
May 18, 2016

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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