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NCT01988272 · ClinicalTrials.gov registry record
Imaging Based Dosimetry for Individualized Internal Emitter Therapy
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 33
- Enrollment target
NCT01988272: Completed study, sponsored by University of Michigan.
NCT01988272 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01988272 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
Tumor absorbed doses will be calculated based on research SPECT/CT imaging and correlated with the response as assessed by clinical PET/CT.
Interventions
- DEVICE SPECT/CT imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-01 |
What the finished NCT01988272 record still lists
NCT01988272 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 33 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which SPECT/CT imaging is the first listed.
NCT01988272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01988272 about?
NCT01988272 is a clinical study titled "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, (...
What is the current status of trial NCT01988272?
This trial is currently completed. The enrollment target is 33 participants. The study started on 2011-06. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01988272?
The interventions under investigation include: SPECT/CT imaging (DEVICE).
Who is sponsoring clinical trial NCT01988272?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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