Imaging Based Dosimetry for Individualized Internal Emitter Therapy

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

Imaging Based Dosimetry for Individualized Internal Emitter Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988272
• Other study ID #: 5R01EB001994
• Status: Completed
• Phase: N/A
• First received: November 5, 2013
• Last updated: May 17, 2016
• Start date: June 2011
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Device:
• SPECT/CT imaging
Patients will undergo scanning on the above system.

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assess correlation between radiation absorbed dose to the bone marrow and hematologic toxicity.	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	No