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The purpose of this study is to determine if quantitative magnetic resonance imaging (qMRI) can objectively measure changes in the tumor/vertebral body and adjacent spinal cord following stereotactic body radiation therapy (SBRT) for painful metastatic spine disease.
Metastatic spine disease (MSD) can result in considerable morbidity from pain, spinal cord compromise and neurologic disability. Recent developments in image-guidance and immobilization have enabled more accurate target localization, which allows methods of precise high-dose radiation delivery such as stereotactic body radiation therapy (SBRT). SBRT carries potential risks of radiation induced myelopathy (RIM) and vertebral compression fracture (VCF). Magnetic resonance imaging (MRI) is a sensitive imaging modality that may be able to detect radiation-induced damage in the vertebral body or spinal cord following SBRT. Quantitative MR-based imaging methods may also help to quantify treatment response and help predict subsequent outcomes such as tumor control and VCF risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quantitative MRI at 4 weeks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| qMRI with Gadoteridol contrast agent | Device | quantitative MR: MRI uses a magnet and radio waves to make medical images of the body. Gadoteridol is used as a contrast agent. Quantitative MRI involves the use of software to analyze the acquired images. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI) | baseline, 4 wks | |
| Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI) | baseline, 4 wks | |
| Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI | baseline, 4 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in numeric pain score as measured by the Numeric Pain Rating Scale | Measured from 0-10 with 0 being no pain and 10 being severe pain | baseline, 4 wks |
| Change in numeric pain score as measured by the Brief Pain Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trey Mullikin, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
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|
Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain
| baseline, 4 wks |
| Change in numeric pain score as measured by the EQ5D Pain Questionnaire | Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain | baseline, 4 wks |
| Change in opioid use | baseline, 4 wks |
| Change in quality of life as measured by the Pat Sf36 V2 assessment | Pat SF36 V2 is a quality of life survey about physical activity, general health and daily functions measured from excellent/much better/yes, limited a lot/all of the time/not at all, through poor/much worse/no,not limited at all/none of the time/extremely with additional not answered option | baseline, 4 wks |
| Change in quality of life as measured by the PROMIS assessment | PROMIS categories include physical function, anxiety, depression, fatigue, sleep and pain ranging from never/not at all through always/very much. | baseline, 4 wks |
| Change in quality of life as measured by the SOSG+ assessment | Questionnaire about physical function, neurological function and pain ranging from never/not at all through always/very much | baseline, 4 wks |