Non-Hodgkin's LymphomaNCT01988272
Imaging Based Dosimetry for Individualized Internal Emitter Therapy
An observational study of Non-Hodgkin's Lymphoma, run by University of Michigan at 1 site in United States.
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 . Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- SPECT/CT imaging
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of Non-Hodgkin Lymphomas
Who may be able to join
- • Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of Non-Hodgkin Lymphomas
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
About this study
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
- Being tested
- SPECT/CT imaging
- Keywords
- SPECT/CT, Dosimetry, Radiation absorbed dose, Non-Hodgkin's Lymphoma, I-131 tositumomab radioimmunotherapy
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT/CT imagingDevice
Also called Siemens Symbia SPECT/CT system
Patients will undergo scanning on the above system.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startJun 2011
- Primary completionMar 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Yuni Dewaraja, University of Michigan
- Investigators
- Yuni Dewaraja, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988272
- Sponsor's protocol ID
- 5R01EB001994
- Status last verified
- May 2016
- First submitted
- 5 Nov 2013
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Based Dosimetry for Individualized Internal Emitter Therapy
- ClinicalTrials.gov ID
- NCT01988272
- Acronym / sponsor ID
- 5R01EB001994
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- SPECT/CT, Dosimetry, Radiation absorbed dose, Non-Hodgkin's Lymphoma, I-131 tositumomab radioimmunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of Non-Hodgkin Lymphomas
Key inclusion criteria (1 listed)
- • Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of Non-Hodgkin Lymphomas
Key exclusion criteria (4 listed)
- • Clinical instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT/CT imagingAlso: Siemens Symbia SPECT/CT systemPatients will undergo scanning on the above system. | Device | – |
Primary outcome
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.
1 secondary outcome
Assess correlation between radiation absorbed dose to the bone marrow and hematologic toxicity.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuni Dewaraja, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin's Lymphoma, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between radiation absorbed dose to tumor and response or progression free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.