2011-11
2015-08
2015-08
25
NCT02019199
Duke University
Duke University
OBSERVATIONAL
Magnetic Resonance Imaging (MRI) in Motion
This study is a research initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation therapy.
The goal with radiation therapy is to treat the defined tumor and spare the surrounding normal tissue from receiving dose above specified tolerance doses. There is evidence of improved local control and survival with higher doses of radiation, however, at the same time there is the need to spare normal tissues from higher doses of radiation. Technologies that allow the delivery of an increased radiation dose to the tumor while sparing normal tissue have the potential of improving the therapeutic ratio. However, the development of these technologies has been hampered by organ respiratory motion particularly in the case of the lungs and liver. Inadequate radiation coverage of a tumor secondary to organ motion can lead to delivering a lower dose to a portion of the tumor. Making the field of radiation larger to account for organ motion results in unnecessary radiation dose to surrounding healthy tissues. It is therefore desirable to document the extent of motion of the organ in question prior to carrying out the radiation treatment planning. The organ motion impacts directly on the radiation dose distribution in the treatment volume.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2013-12-18 | N/A | 2017-07-07 |
2013-12-18 | N/A | 2017-07-11 |
2013-12-24 | N/A | 2017-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| To evaluate the accuracy, robustness, and efficacy of MRI for tumor motion measurement. | MRI and CT ( all subjects will have a standard of care CT scan) data in DICOM format will be collected for analysis using commercial or customized - developed software. Image quality will be assessed based on signal-to-noise (SNR), contrast-to-noise ratio (CNR), and the presence of image artifacts. Data to be computed include, but are not limited to, tumor volumes (gross tumor volume, internal target volume, planning target volume, etc.), tumor motion parameters (range, trajectory, frequency, variation, probability distribution, etc.), and treatment plan parameters (target coverage, dose-volume-histogram, etc.). | During MRI approx 1 hour |
| Tumor volume | Free breathing/breath-hold MRI will be compared to free breathing/breath-hold CT | During MRI approx 1 hour |
| Tumor contrast-to-noise ratio (CNR) | Difference between CNR is measured by 4D-MRI and 4D-CT | During MRI approx 1 hour |
| Tumor Motion | Difference between tumor motion as measured by 2D cine-MRI vs 4D-MRI vs 4D-CT | During MRI approx 1 hour |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
21 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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