Imaging Based Dosimetry for Individualized Internal Emitter Therapy

May 17, 2016 updated by: Yuni Dewaraja, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Yuni Dewaraja, PhD, University of Michigan

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

June 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01EB001994 (U.S. NIH Grant/Contract)

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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