Imaging Based Dosimetry for Individualized Internal Emitter Therapy

NCT01988272 | Completed DMC

• 1 other identifier: 5R01EB001994
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

SPECT/CT; Dosimetry; Radiation absorbed dose; Non-Hodgkin's Lymphoma; I-131 tositumomab radioimmunotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  6 months

Interventions

SPECT/CT imaging DEVICE

Patients will undergo scanning on the above system.

Also known as: Siemens Symbia SPECT/CT system

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuni Dewaraja, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 20, 2013
• Study Start: June 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

US (1)